Trial Outcomes & Findings for FOcal Radiation for Oligometastatic Castration-rEsistant Prostate Cancer (FORCE) (NCT NCT03556904)

Last Updated: 2026-01-15

Results Overview

Duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. A patient's designated response at any one time is a combination of the assessment of target lesions, non-target lesions, bone lesions and disease symptoms. Progression in this measure is defined as worsened pain or new sites of disease on imaging. Progression by pain due to prostate cancer requires evidence of disease at the site of pain and one or more palliative intervention (opioid therapy for 10 out of 14 consecutive days, radionuclide therapy or radiation therapy). Response and progression definitions used will be a combination of the criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee v1.1 and the Prostate Cancer Working Group 3.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

At 12 Months

Results posted on

2026-01-15

Participant Flow

Participant milestones

Participant milestones
Measure	Standard of Care Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.	Standard of Care + Ablative Radiation Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Ablative Radiation Therapy: Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.
Overall Study STARTED	9	5
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	8	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard of Care Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.	Standard of Care + Ablative Radiation Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Ablative Radiation Therapy: Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.
Overall Study Disease Progression after treatment started	3	3
Overall Study Sponsor Termination	2	2
Overall Study Physician Decision	2	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

FOcal Radiation for Oligometastatic Castration-rEsistant Prostate Cancer (FORCE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care n=9 Participants Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.	Standard of Care + Ablative Radiation n=5 Participants Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Ablative Radiation Therapy: Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=9 Participants	3 Participants n=6 Participants	3 Participants n=9 Participants
Age, Categorical >=65 years	9 Participants n=9 Participants	2 Participants n=6 Participants	11 Participants n=9 Participants
Sex: Female, Male Female	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Sex: Female, Male Male	9 Participants n=9 Participants	5 Participants n=6 Participants	14 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=9 Participants	5 Participants n=6 Participants	14 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	1 Participants n=9 Participants	1 Participants n=6 Participants	2 Participants n=9 Participants
Race (NIH/OMB) White	8 Participants n=9 Participants	4 Participants n=6 Participants	12 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Region of Enrollment United States	9 participants n=9 Participants	5 participants n=6 Participants	14 participants n=9 Participants

PRIMARY outcome

Timeframe: At 12 Months

Population: NA- Per biostatistician, values must be reported as NA due to lack of data from insufficient number of participants with events. Data is not available now nor will it be available in the future

Outcome measures

Outcome measures
Measure	Standard of Care n=9 Participants Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.	Standard of Care + Ablative Radiation n=5 Participants Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Ablative Radiation Therapy: Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.
Median Duration of Response	NA months Standard Deviation NA NA- Per biostatistician, values must be reported as NA due to lack of data from insufficient number of participants with events. Data is not available now nor will it be available in the future	NA months Standard Deviation NA NA- Per biostatistician, values must be reported as NA due to lack of data from insufficient number of participants with events. Data is not available now nor will it be available in the future

SECONDARY outcome

Timeframe: At 24 months

PFS is defined as the duration of time from start of treatment to date of progression or death (whichever is first). Initiation of other prostate directed therapies (excluding bisphosphonates or RANKL inhibitors) is considered to be progression. Reported as Kaplan-Meier estimates, including median at 12 months and 24 month.

Outcome measures

Outcome measures
Measure	Standard of Care n=9 Participants Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.	Standard of Care + Ablative Radiation n=5 Participants Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Ablative Radiation Therapy: Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.
Median Objective Progression Free Survival (PFS) Time	NA Months NA- Per biostatistician, values must be reported as NA due to lack of data from insufficient number of participants with events. Data is not available now nor will it be available in the future	26 Months Interval 22.0 to 100.0

SECONDARY outcome

Timeframe: At 24 months

The Median PSA PFS is defined as the median duration of time from start of treatment to date that PSA progression is documented or death occurs (whichever is first). PSA progression is defined as a 25% increase over baseline or nadir whichever is lower and an increase in the absolute value of PSA level by 2 ng/ml. Reported as Kaplan-Meier estimates, including median at 12 months and 24 month.

Outcome measures

Outcome measures
Measure	Standard of Care n=9 Participants Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.	Standard of Care + Ablative Radiation n=5 Participants Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Ablative Radiation Therapy: Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.
Median Prostate Specific Antigen (PSA) PFS	NA months NA- Per biostatistician, values must be reported as NA due to lack of data from insufficient number of participants with events. Data is not available now nor will it be available in the future	NA months NA- Per biostatistician, values must be reported as NA due to lack of data from insufficient number of participants with events. Data is not available now nor will it be available in the future

SECONDARY outcome

Timeframe: At 24 months

Radiographic PFS is defined as the duration of time from start of treatment to date that progression is radio-graphically documented or death occurs (whichever is first). Reported as Kaplan-Meier estimates, including median at 12 months and 24 month.

Outcome measures

Outcome measures
Measure	Standard of Care n=9 Participants Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.	Standard of Care + Ablative Radiation n=5 Participants Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Ablative Radiation Therapy: Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.
Median Radiographic PFS	NA Months NA- Per biostatistician, values must be reported as NA due to lack of data from insufficient number of participants with events. Data is not available now nor will it be available in the future	26 Months Interval 22.0 to 100.0

SECONDARY outcome

Timeframe: 24 months

Overall survival (OS) is defined as the duration of time from start of treatment to death. Reported as Kaplan-Meier estimates, including median at 12 months and 24 month.

Outcome measures

Outcome measures
Measure	Standard of Care n=9 Participants Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.	Standard of Care + Ablative Radiation n=5 Participants Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Ablative Radiation Therapy: Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.
Overall Survival Time	NA months NA- Per biostatistician, values must be reported as NA due to lack of data from insufficient number of participants with events. Data is not available now nor will it be available in the future	NA months NA- Per biostatistician, values must be reported as NA due to lack of data from insufficient number of participants with events. Data is not available now nor will it be available in the future

SECONDARY outcome

Timeframe: 24 months

Prostate Cancer Specific Survival (PCSS) is defined as the duration of time from start of treatment to death from prostate cancer. Reported as Kaplan-Meier estimates, including median at 12 months and 24 month.

Outcome measures

Outcome measures
Measure	Standard of Care n=9 Participants Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.	Standard of Care + Ablative Radiation n=5 Participants Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Ablative Radiation Therapy: Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.
Prostate Cancer Specific Survival Time	NA days NA- Per biostatistician, values must be reported as NA due to lack of data from insufficient number of participants with events. Data is not available now nor will it be available in the future	NA days NA- Per biostatistician, values must be reported as NA due to lack of data from insufficient number of participants with events. Data is not available now nor will it be available in the future

SECONDARY outcome

Timeframe: At 24 months

Non-irradiated metastases free survival is defined as the duration of time from start of treatment to the date of progressive disease of a new target lesion, a new non-measurable/non-target lesion or emergence of 2 or more new skeletal lesions on a bone scan. Reported as Kaplan-Meier estimates, including median at 12 months and 24 month.

Outcome measures

Outcome measures
Measure	Standard of Care n=9 Participants Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.	Standard of Care + Ablative Radiation n=5 Participants Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Ablative Radiation Therapy: Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.
Non-irradiated Metastases Free Survival Time	NA days NA- Per biostatistician, values must be reported as NA due to lack of data from insufficient number of participants with events. Data is not available now nor will it be available in the future	NA days NA- Per biostatistician, values must be reported as NA due to lack of data from insufficient number of participants with events. Data is not available now nor will it be available in the future

SECONDARY outcome

Timeframe: 24 months

The number of patients whose PSA becomes undetectable (≤0.2 ng/ml) will be counted in each treatment arm and divided by the number of patients who received any protocol treatment to provide the proportion of patients with complete PSA response. Complete PSA response is defined as an undetectable PSA (≤0.2 ng/ml).

Outcome measures

Outcome measures
Measure	Standard of Care n=9 Participants Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.	Standard of Care + Ablative Radiation n=5 Participants Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Ablative Radiation Therapy: Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.
The Proportion of Patients With Complete PSA Response	67 percentage of patients Interval 30.0 to 93.0	40 percentage of patients Interval 5.0 to 85.0

SECONDARY outcome

Timeframe: 24 months

The number of patients whose PSA declines by 50% decline (PSA partial response 50 (PR50)) will be counted in each treatment arm and divided by the number of patients who received any protocol treatment to provide the proportion of patients with PR50. PR50 response is defined as a decrease in PSA value by ≥ 50%.

Outcome measures

Outcome measures
Measure	Standard of Care n=9 Participants Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.	Standard of Care + Ablative Radiation n=5 Participants Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Ablative Radiation Therapy: Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.
The Proportion of Patients With a PSA Partial Response 50 (PR50)	89 percentage of patients Interval 52.0 to 100.0	60 percentage of patients Interval 15.0 to 95.0

SECONDARY outcome

Timeframe: 24 months

The number of patients whose PSA declines by 90% decline (PSA partial response 90 (PR90)) will be counted in each treatment arm and divided by the number of patients who received any protocol treatment to provide the proportion of patients with PR90. PR90 response is defined as a decrease in PSA value by ≥ 90%.

Outcome measures

Outcome measures
Measure	Standard of Care n=9 Participants Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.	Standard of Care + Ablative Radiation n=5 Participants Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Ablative Radiation Therapy: Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.
The Proportion of Patients With a PSA Partial Response 90 (PR90)	44 percentage of patients Interval 14.0 to 79.0	60 percentage of patients Interval 14.0 to 95.0

SECONDARY outcome

Timeframe: 24 months

The measurable disease response rate (CR + PR) will be calculated for patients evaluable for measurable disease response. Complete response (CR) is defined as a disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduced in short axis to \<10 mm. There can be no appearance of new lesions. Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions.

Outcome measures

Outcome measures
Measure	Standard of Care n=9 Participants Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.	Standard of Care + Ablative Radiation n=5 Participants Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Ablative Radiation Therapy: Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.
The Proportion of Patients That Respond to Treatment	22 percentage of patients Interval 1.0 to 72.0	20 percentage of patients Interval 5.0 to 51.0

SECONDARY outcome

Timeframe: measured at 6 and 12 months post starting treatment

Population: score range is 0-68 with higher scores indicating better health

The National Comprehensive Cancer Network Functional Assessment of Cancer Therapy - Prostate Symptom Index (NFPSI-17), version 2 is used to assess high priority symptoms/QOL concerns in patients with advanced prostate cancer (PC). It is a 17-item survey with a recall period of the past 7 days; scored using a 5 point Likert-type scale. Items are scored from 1-4 with some items reverse scored. Described using means or medians. score range is 0-68 with higher scores indicating better health

Outcome measures

Outcome measures
Measure	Standard of Care n=9 Participants Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.	Standard of Care + Ablative Radiation n=5 Participants Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Ablative Radiation Therapy: Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.
Patient-reported Outcome Based on NCCN-FACT FPSI-17 (Version 2) 6 Months	41.5 score on a scale Interval 37.5 to 45.4	39.1 score on a scale Interval 33.6 to 44.6
Patient-reported Outcome Based on NCCN-FACT FPSI-17 (Version 2) 12 Months	41.8 score on a scale Interval 36.6 to 47.1	39.7 score on a scale Interval 31.0 to 48.4

Adverse Events

Standard of Care

Serious events: 3 serious events

Other events: 9 other events

Deaths: 2 deaths

Standard of Care + Ablative Radiation

Serious events: 0 serious events

Other events: 5 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Standard of Care n=9 participants at risk Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.	Standard of Care + Ablative Radiation n=5 participants at risk Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Ablative Radiation Therapy: Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy.
General disorders Fall	11.1% 1/9 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 4 year and 7 month period for an average of 20 months per patient.	0.00% 0/5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 4 year and 7 month period for an average of 20 months per patient.
General disorders Fatigue	11.1% 1/9 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 4 year and 7 month period for an average of 20 months per patient.	0.00% 0/5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 4 year and 7 month period for an average of 20 months per patient.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	11.1% 1/9 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 4 year and 7 month period for an average of 20 months per patient.	0.00% 0/5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 4 year and 7 month period for an average of 20 months per patient.
Nervous system disorders Stroke	11.1% 1/9 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 4 year and 7 month period for an average of 20 months per patient.	0.00% 0/5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 4 year and 7 month period for an average of 20 months per patient.

Other adverse events

Additional Information

University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin

University of Michigan Rogel Cancer Center

Phone: 734-936-9499

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place