Trial Outcomes & Findings for The UPPROACH (Upfront Intensity Modulated Proton Beam Therapy) Approach (NCT NCT04527900)

Results Overview

This will be measured as proportion of patients completing full 6 cycles of chemotherapy concurrently with IMPT

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

End of study, approximately 4 years

Results posted on

2026-07-08

Participant Flow

Recruitment ended early due to low accrual, study terminated before outcome measure data was collected.

Participant milestones

Participant milestones
Measure	Concurrent Chemoradiation Concurrent carboplatin and paclitaxel and IMPT (Intensity Modulated Proton Therapy)
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Concurrent Chemoradiation Concurrent carboplatin and paclitaxel and IMPT (Intensity Modulated Proton Therapy)
Overall Study Adverse Event	1

Baseline Characteristics

The UPPROACH (Upfront Intensity Modulated Proton Beam Therapy) Approach

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Concurrent Chemoradiation n=2 Participants Concurrent carboplatin and paclitaxel and IMPT (Intensity Modulated Proton Therapy) carboplatin and paclitaxel: carboplatin and paclitaxel 5-6 cycles (dosage per standard of care according to treating oncologist) pelvic IMPT (Intensity Modulated Proton Therapy): whole pelvis will receive a total dose of 4500 cGy in 25 fractions to 5040 cGy in 28 fractions
Age, Categorical <=18 years	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=9 Participants
Age, Categorical >=65 years	0 Participants n=9 Participants
Age, Continuous	58 years n=9 Participants
Sex: Female, Male Female	2 Participants n=9 Participants
Sex: Female, Male Male	0 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	2 Participants n=9 Participants
Race (NIH/OMB) White	0 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants
Region of Enrollment United States	2 Participants n=9 Participants

PRIMARY outcome

Timeframe: End of study, approximately 4 years

Population: One participant completed chemotherapy and IMPT- trial to did not complete accrual.

This will be measured as proportion of patients completing full 6 cycles of chemotherapy concurrently with IMPT

Outcome measures

Outcome measures
Measure	Concurrent Chemoradiation n=1 Participants Concurrent carboplatin and paclitaxel and IMPT (Intensity Modulated Proton Therapy) carboplatin and paclitaxel: carboplatin and paclitaxel 5-6 cycles (dosage per standard of care according to treating oncologist) pelvic IMPT (Intensity Modulated Proton Therapy): whole pelvis will receive a total dose of 4500 cGy in 25 fractions to 5040 cGy in 28 fractions
Number of Participants Who Completed Full 6 Cycles of Chemotherapy Concurrently With IMPT	1 Participants

SECONDARY outcome

Timeframe: once a week during radiation treatment, up to 5-6 weeks

Population: One participant reported with Acute GI and Urinary Toxicity- trial to did not complete accrual. Second patient was removed prior to started concurrent chemoRT.

Measured by CTCAE (Common Terminology Criteria for Adverse Events). Toxicities noted did not meet the criteria for Serious Adverse Event. No SAEs noted.

Outcome measures

Outcome measures
Measure	Concurrent Chemoradiation n=1 Participants Concurrent carboplatin and paclitaxel and IMPT (Intensity Modulated Proton Therapy) carboplatin and paclitaxel: carboplatin and paclitaxel 5-6 cycles (dosage per standard of care according to treating oncologist) pelvic IMPT (Intensity Modulated Proton Therapy): whole pelvis will receive a total dose of 4500 cGy in 25 fractions to 5040 cGy in 28 fractions
Number of Participants With Acute GI and Urinary Toxicity	1 Participants

SECONDARY outcome

Timeframe: once a week during radiation treatment, up to 5-6 weeks

Population: One participant reported with Acute GI and Urinary Toxicity- trial to did not complete accrual. Second patient was removed prior to started concurrent chemoRT.

Measured by PRO-CTCAE (Patient reported outcomes Common Terminology Criteria for Adverse Events)

Outcome measures

Outcome measures
Measure	Concurrent Chemoradiation n=1 Participants Concurrent carboplatin and paclitaxel and IMPT (Intensity Modulated Proton Therapy) carboplatin and paclitaxel: carboplatin and paclitaxel 5-6 cycles (dosage per standard of care according to treating oncologist) pelvic IMPT (Intensity Modulated Proton Therapy): whole pelvis will receive a total dose of 4500 cGy in 25 fractions to 5040 cGy in 28 fractions
Number of Participants With Acute GI and Urinary Toxicity Measured by PRO-CTCAE	0 Participants

SECONDARY outcome

Timeframe: once a week during radiation treatment, up to 5-6 weeks

Population: One participant reported with Acute GI and Urinary Toxicity- trial to did not complete accrual. Second patient was removed prior to started concurrent chemoRT.

Measured by EPIC (Expanded Prostate Cancer Index Composite ) bowel and urinary domain

Outcome measures

Outcome measures
Measure	Concurrent Chemoradiation n=1 Participants Concurrent carboplatin and paclitaxel and IMPT (Intensity Modulated Proton Therapy) carboplatin and paclitaxel: carboplatin and paclitaxel 5-6 cycles (dosage per standard of care according to treating oncologist) pelvic IMPT (Intensity Modulated Proton Therapy): whole pelvis will receive a total dose of 4500 cGy in 25 fractions to 5040 cGy in 28 fractions
Number of Participants With Acute GI and Urinary Toxicity Measured by EPIC	1 Participants

SECONDARY outcome

Timeframe: Prior to each cycle of chemotherapy (once every 21 days for 106 days)

Population: One participant reviewed for acute hematologic toxicity- trial to did not complete accrual. Second patient was removed prior to started concurrent chemoRT.

Measured by CTCAE (Common Terminology Criteria for Adverse Events). Toxicities noted did not meet the criteria for Serious Adverse Event. No SAEs noted.

Outcome measures

Outcome measures
Measure	Concurrent Chemoradiation n=1 Participants Concurrent carboplatin and paclitaxel and IMPT (Intensity Modulated Proton Therapy) carboplatin and paclitaxel: carboplatin and paclitaxel 5-6 cycles (dosage per standard of care according to treating oncologist) pelvic IMPT (Intensity Modulated Proton Therapy): whole pelvis will receive a total dose of 4500 cGy in 25 fractions to 5040 cGy in 28 fractions
Number of Participants With Acute Hematologic Toxicity	0 Participants

SECONDARY outcome

Timeframe: 6-month following radiation therapy

Population: One participant reviewed for GI and urinary toxicity- trial to did not complete accrual. Second patient was removed prior to started concurrent chemoRT.

Measured by CTCAE (Common Terminology Criteria for Adverse Events)

Outcome measures

Outcome measures
Measure	Concurrent Chemoradiation n=1 Participants Concurrent carboplatin and paclitaxel and IMPT (Intensity Modulated Proton Therapy) carboplatin and paclitaxel: carboplatin and paclitaxel 5-6 cycles (dosage per standard of care according to treating oncologist) pelvic IMPT (Intensity Modulated Proton Therapy): whole pelvis will receive a total dose of 4500 cGy in 25 fractions to 5040 cGy in 28 fractions
Number of Participants With Late GI and Urinary Toxicity	1 Participants

SECONDARY outcome

Timeframe: 6-month following radiation therapy

Population: One participant reviewed for late GI and urinary toxicity- trial to did not complete accrual. Second patient was removed prior to started concurrent chemoRT.

Measured by PRO-CTCAE (Patient reported outcomes Common Terminology Criteria for Adverse Events)

Outcome measures

Outcome measures
Measure	Concurrent Chemoradiation n=1 Participants Concurrent carboplatin and paclitaxel and IMPT (Intensity Modulated Proton Therapy) carboplatin and paclitaxel: carboplatin and paclitaxel 5-6 cycles (dosage per standard of care according to treating oncologist) pelvic IMPT (Intensity Modulated Proton Therapy): whole pelvis will receive a total dose of 4500 cGy in 25 fractions to 5040 cGy in 28 fractions
Number of Participants With Late GI and Urinary Toxicity Per PRO-CTCAE	1 Participants

SECONDARY outcome

Timeframe: 6-month following radiation therapy

Population: One participant reviewed for GI and urinary toxicity- trial to did not complete accrual. Second patient was removed prior to started concurrent chemoRT.

Measured by EPIC (Expanded Prostate Cancer Index Composite ) bowel and urinary domain

Outcome measures

Outcome measures
Measure	Concurrent Chemoradiation n=1 Participants Concurrent carboplatin and paclitaxel and IMPT (Intensity Modulated Proton Therapy) carboplatin and paclitaxel: carboplatin and paclitaxel 5-6 cycles (dosage per standard of care according to treating oncologist) pelvic IMPT (Intensity Modulated Proton Therapy): whole pelvis will receive a total dose of 4500 cGy in 25 fractions to 5040 cGy in 28 fractions
Number of Participants With Late GI and Urinary Toxicity Measured by EPIC	1 Participants

Adverse Events

Concurrent Chemoradiation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Concurrent Chemoradiation n=2 participants at risk Concurrent carboplatin and paclitaxel and IMPT (Intensity Modulated Proton Therapy) carboplatin and paclitaxel: carboplatin and paclitaxel 5-6 cycles (dosage per standard of care according to treating oncologist) pelvic IMPT (Intensity Modulated Proton Therapy): whole pelvis will receive a total dose of 4500 cGy in 25 fractions to 5040 cGy in 28 fractions
Metabolism and nutrition disorders Anorexia	50.0% 1/2 • Up to 14 months post enrollment Adverse Events were assessed weekly during treatment and then at each follow-up visit per protocol.
Renal and urinary disorders Urinary Urgency	50.0% 1/2 • Up to 14 months post enrollment Adverse Events were assessed weekly during treatment and then at each follow-up visit per protocol.
General disorders Fatigue	50.0% 1/2 • Up to 14 months post enrollment Adverse Events were assessed weekly during treatment and then at each follow-up visit per protocol.
Renal and urinary disorders Urinary Frequency	50.0% 1/2 • Up to 14 months post enrollment Adverse Events were assessed weekly during treatment and then at each follow-up visit per protocol.
Renal and urinary disorders Urinary Incontinence	50.0% 1/2 • Up to 14 months post enrollment Adverse Events were assessed weekly during treatment and then at each follow-up visit per protocol.
Reproductive system and breast disorders Dyspareunia	50.0% 1/2 • Up to 14 months post enrollment Adverse Events were assessed weekly during treatment and then at each follow-up visit per protocol.
Immune system disorders Infusion Reaction	50.0% 1/2 • Up to 14 months post enrollment Adverse Events were assessed weekly during treatment and then at each follow-up visit per protocol.

Additional Information

Caitlin Eggleston, Director of Clinical Research

University of Maryland Medical Center

Phone: 410-369-5351

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place