Trial Outcomes & Findings for Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer (NCT NCT03298087)
NCT ID: NCT03298087
Last Updated: 2025-08-01
Results Overview
PSA is a biomarker for disease burden in prostate adenocarcinoma and offers a non-invasive and sensitive assessment of disease control after treatment in the vast majority of patients.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
6 months after recovery of testosterone
Results posted on
2025-08-01
Participant Flow
Participant milestones
| Measure |
Experimental Arm
Radical prostatectomy (and post-operative fractionated radiotherapy for pT=3a, pN1, or positive margins), metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy.
radical prostatectomy: surgical removal of the prostate
stereotactic body radiotherapy: Highly targeted radiation
Leuprolide: Lowers serum testosterone
apalutamide: antiandrogen
abiraterone: Inhibits androgen synthesis
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Experimental Arm
Radical prostatectomy (and post-operative fractionated radiotherapy for pT=3a, pN1, or positive margins), metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy.
radical prostatectomy: surgical removal of the prostate
stereotactic body radiotherapy: Highly targeted radiation
Leuprolide: Lowers serum testosterone
apalutamide: antiandrogen
abiraterone: Inhibits androgen synthesis
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
Experimental Arm
n=28 Participants
Radical prostatectomy (and post-operative fractionated radiotherapy for pT=3a, pN1, or positive margins), metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy.
radical prostatectomy: surgical removal of the prostate
stereotactic body radiotherapy: Highly targeted radiation
Leuprolide: Lowers serum testosterone
apalutamide: antiandrogen
abiraterone: Inhibits androgen synthesis
|
|---|---|
|
Age, Continuous
|
69 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 months after recovery of testosteronePSA is a biomarker for disease burden in prostate adenocarcinoma and offers a non-invasive and sensitive assessment of disease control after treatment in the vast majority of patients.
Outcome measures
| Measure |
Experimental Arm
n=24 Participants
Radical prostatectomy (and post-operative fractionated radiotherapy for pT=3a, pN1, or positive margins), metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy.
radical prostatectomy: surgical removal of the prostate
stereotactic body radiotherapy: Highly targeted radiation
Leuprolide: Lowers serum testosterone
apalutamide: antiandrogen
abiraterone: Inhibits androgen synthesis
|
|---|---|
|
Percentage of Participants With PSA<0.05ng/mL (Radical Prostatectomy) or PSA <Nadir+2ng/mL (Prostate Radiation)
|
20 Participants
|
SECONDARY outcome
Timeframe: up to 5 yearsbiochemical, radiographic, or clinical
Outcome measures
| Measure |
Experimental Arm
n=24 Participants
Radical prostatectomy (and post-operative fractionated radiotherapy for pT=3a, pN1, or positive margins), metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy.
radical prostatectomy: surgical removal of the prostate
stereotactic body radiotherapy: Highly targeted radiation
Leuprolide: Lowers serum testosterone
apalutamide: antiandrogen
abiraterone: Inhibits androgen synthesis
|
|---|---|
|
Time to Biochemical Progression
|
NA months
Median and 95% Confidence Interval would not be reached because there were only three biochemical progressions.
|
SECONDARY outcome
Timeframe: up to 5 yearsper PCWG3 criteria
Outcome measures
| Measure |
Experimental Arm
n=24 Participants
Radical prostatectomy (and post-operative fractionated radiotherapy for pT=3a, pN1, or positive margins), metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy.
radical prostatectomy: surgical removal of the prostate
stereotactic body radiotherapy: Highly targeted radiation
Leuprolide: Lowers serum testosterone
apalutamide: antiandrogen
abiraterone: Inhibits androgen synthesis
|
|---|---|
|
Time to Radiographic Progression
|
NA months
Median and 95% Confidence Interval would not be reached because there were only three radiographic progressions.
|
SECONDARY outcome
Timeframe: up to 5 yearsantineoplastic therapy includes any systemic or focal anti-prostate cancer therapy
Outcome measures
| Measure |
Experimental Arm
n=24 Participants
Radical prostatectomy (and post-operative fractionated radiotherapy for pT=3a, pN1, or positive margins), metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy.
radical prostatectomy: surgical removal of the prostate
stereotactic body radiotherapy: Highly targeted radiation
Leuprolide: Lowers serum testosterone
apalutamide: antiandrogen
abiraterone: Inhibits androgen synthesis
|
|---|---|
|
Time to Initiation of Additional Antineoplastic Therapy
|
NA months
Median and 95% Confidence Interval would not be reached because there were only three who had addition antineoplastic therapy initiated.
|
SECONDARY outcome
Timeframe: up to 5 yearsProstate cancer specific survival
Outcome measures
| Measure |
Experimental Arm
n=24 Participants
Radical prostatectomy (and post-operative fractionated radiotherapy for pT=3a, pN1, or positive margins), metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy.
radical prostatectomy: surgical removal of the prostate
stereotactic body radiotherapy: Highly targeted radiation
Leuprolide: Lowers serum testosterone
apalutamide: antiandrogen
abiraterone: Inhibits androgen synthesis
|
|---|---|
|
Prostate Cancer Specific Survival
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Every 3 months up to a total of 21 monthsPopulation: We could only analyze patients who agreed to fill out the questionnaires.
This uses the Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire. It assesses patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Items are rated on a 0 to 4 Likert type scale and combined to produce sub-scores that are summed into a total FACT-P score, the higher the score, the better the quality of life. Range from 0-150 . Data was aggregated per patient and over time. Data represented here are the mean scores and 95% confidence intervals of the participants who filled out the questionnaire (15/24 completed through 18 months, 12/24 completed through 21 months).
Outcome measures
| Measure |
Experimental Arm
n=24 Participants
Radical prostatectomy (and post-operative fractionated radiotherapy for pT=3a, pN1, or positive margins), metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy.
radical prostatectomy: surgical removal of the prostate
stereotactic body radiotherapy: Highly targeted radiation
Leuprolide: Lowers serum testosterone
apalutamide: antiandrogen
abiraterone: Inhibits androgen synthesis
|
|---|---|
|
Patient Reported Outcomes as Assessed by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Scale - Patient Questionnaire
Month 9
|
119 Score on a Scale
Interval 107.0 to 131.0
|
|
Patient Reported Outcomes as Assessed by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Scale - Patient Questionnaire
Month 12
|
120 Score on a Scale
Interval 110.0 to 131.0
|
|
Patient Reported Outcomes as Assessed by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Scale - Patient Questionnaire
Month 18
|
122 Score on a Scale
Interval 112.0 to 133.0
|
|
Patient Reported Outcomes as Assessed by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Scale - Patient Questionnaire
Month 0
|
118 Score on a Scale
Interval 108.0 to 129.0
|
|
Patient Reported Outcomes as Assessed by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Scale - Patient Questionnaire
Month 3
|
112 Score on a Scale
Interval 103.0 to 122.0
|
|
Patient Reported Outcomes as Assessed by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Scale - Patient Questionnaire
Month 6
|
115 Score on a Scale
Interval 106.0 to 124.0
|
|
Patient Reported Outcomes as Assessed by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Scale - Patient Questionnaire
Month 15
|
120 Score on a Scale
Interval 108.0 to 131.0
|
|
Patient Reported Outcomes as Assessed by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Scale - Patient Questionnaire
Month 21
|
113 Score on a Scale
Interval 100.0 to 127.0
|
SECONDARY outcome
Timeframe: up to 5 yearsCTCAE v4 criteria are a set of criteria for the standardized classification of adverse effects cancer therapy. The CTCAE system is a product of the US National Cancer Institute. The criteria are assessed by physician. The grades range from 0 to 5 (higher is worse). Data will be aggregated per patient and over time and classified by organ system (e.g., genitourinary, gastrointestinal, etc).
Outcome measures
| Measure |
Experimental Arm
n=24 Participants
Radical prostatectomy (and post-operative fractionated radiotherapy for pT=3a, pN1, or positive margins), metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy.
radical prostatectomy: surgical removal of the prostate
stereotactic body radiotherapy: Highly targeted radiation
Leuprolide: Lowers serum testosterone
apalutamide: antiandrogen
abiraterone: Inhibits androgen synthesis
|
|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by Physician Using CTCAE v4.0 Criteria
Grade 2
|
19 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by Physician Using CTCAE v4.0 Criteria
Grade 3
|
2 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by Physician Using CTCAE v4.0 Criteria
Grade 4
|
1 Participants
|
Adverse Events
Experimental Arm
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental Arm
n=28 participants at risk
Radical prostatectomy (and post-operative fractionated radiotherapy for pT=3a, pN1, or positive margins), metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy.
radical prostatectomy: surgical removal of the prostate
stereotactic body radiotherapy: Highly targeted radiation
Leuprolide: Lowers serum testosterone
apalutamide: antiandrogen
abiraterone: Inhibits androgen synthesis
|
|---|---|
|
Blood and lymphatic system disorders
hypokalemia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected for 60 months after start date.
Functional Assessment of Cancer Therapy-Prostate (FACT-P) was recorded every 3 months from baseline to a max of 21 months.
|
Other adverse events
| Measure |
Experimental Arm
n=28 participants at risk
Radical prostatectomy (and post-operative fractionated radiotherapy for pT=3a, pN1, or positive margins), metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy.
radical prostatectomy: surgical removal of the prostate
stereotactic body radiotherapy: Highly targeted radiation
Leuprolide: Lowers serum testosterone
apalutamide: antiandrogen
abiraterone: Inhibits androgen synthesis
|
|---|---|
|
Cardiac disorders
hypertension
|
3.6%
1/28 • Number of events 1 • Adverse events were collected for 60 months after start date.
Functional Assessment of Cancer Therapy-Prostate (FACT-P) was recorded every 3 months from baseline to a max of 21 months.
|
|
Hepatobiliary disorders
transaminitis
|
7.1%
2/28 • Number of events 2 • Adverse events were collected for 60 months after start date.
Functional Assessment of Cancer Therapy-Prostate (FACT-P) was recorded every 3 months from baseline to a max of 21 months.
|
|
Skin and subcutaneous tissue disorders
rash
|
10.7%
3/28 • Number of events 3 • Adverse events were collected for 60 months after start date.
Functional Assessment of Cancer Therapy-Prostate (FACT-P) was recorded every 3 months from baseline to a max of 21 months.
|
|
Nervous system disorders
concentration impairment
|
3.6%
1/28 • Number of events 1 • Adverse events were collected for 60 months after start date.
Functional Assessment of Cancer Therapy-Prostate (FACT-P) was recorded every 3 months from baseline to a max of 21 months.
|
|
Renal and urinary disorders
incontinence
|
25.0%
7/28 • Number of events 7 • Adverse events were collected for 60 months after start date.
Functional Assessment of Cancer Therapy-Prostate (FACT-P) was recorded every 3 months from baseline to a max of 21 months.
|
|
Renal and urinary disorders
cystitis
|
3.6%
1/28 • Number of events 1 • Adverse events were collected for 60 months after start date.
Functional Assessment of Cancer Therapy-Prostate (FACT-P) was recorded every 3 months from baseline to a max of 21 months.
|
|
Renal and urinary disorders
urinary urgency
|
7.1%
2/28 • Number of events 2 • Adverse events were collected for 60 months after start date.
Functional Assessment of Cancer Therapy-Prostate (FACT-P) was recorded every 3 months from baseline to a max of 21 months.
|
|
Renal and urinary disorders
urinary flow requiring tamsulosin
|
14.3%
4/28 • Number of events 4 • Adverse events were collected for 60 months after start date.
Functional Assessment of Cancer Therapy-Prostate (FACT-P) was recorded every 3 months from baseline to a max of 21 months.
|
|
Gastrointestinal disorders
rectal proctitis
|
3.6%
1/28 • Number of events 1 • Adverse events were collected for 60 months after start date.
Functional Assessment of Cancer Therapy-Prostate (FACT-P) was recorded every 3 months from baseline to a max of 21 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place