A Phase 3 interventional study of Radiation and Androgen Suppression Therapy in Prostate Cancer, sponsored by Proton Collaborative Group. Recruiting at 4 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Proton Collaborative Group · Phase 3, Interventional, and Treatment
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Among 3,595 studies in Prostatic Neoplasms with a site in United States — 607 open to participants now, 977 under way, 101 of them phase 3. Prostatic Neoplasms · United States.
Among the 3,595 studies in Prostatic Neoplasms with a site in United States, this one is the 572nd largest by planned enrollment of the 3,023 interventional ones that give a count, is one of 120 that started in 2012, is one of 284 in phase 3, reaches primary completion later than 563 of the 971 other live ones, and was the 1,281st registered.
7,047 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.
Browse Prostatic Neoplasms studies →607 of the 3,595 studies in Prostatic Neoplasms with a site in United States are open now. Recruiting first, the newest first:
City of Hope Medical Center · Sites in United States
Ages 40–80 · Men only
Fred Hutchinson Cancer Center · Sites in United States
Ages 18+ · Men only
University of Michigan Rogel Cancer Center · Sites in United States
Ages 50–75 · Men only · Healthy volunteers
Clinton Bahler · Sites in United States
Ages 18+ · Men only
University of Miami · Sites in United States
Ages 18+ · Men only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
3,595 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 898 · Phase 2 1,383 · Phase 3 321 · Phase 4 50
First in 1988; this study’s year is marked. 120 started in 2012.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 192 is above the median of 60 across 5,349 interventional studies indexed under Prostatic Neoplasms.
Median enrollment 48 across the 3,023 interventional studies, 157 across the 477 observational. Of the 2,355 that completed or were terminated, 997 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
921 of 3,595 have an industry lead sponsor. The 10 most frequent:
Proton Collaborative Group is the lead sponsor of 10 studies on the registry; 6 are open to participants now.
Proton Collaborative Group has 4 studies filed under Prostatic Neoplasms — fewer than ten, so there is no comparison to draw.
338 of the studies in Prostatic Neoplasms with a site in United States that are under way reach primary completion within a year, 25 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03348670Phase 3Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB ChairPharmacogenomics IND Commercial SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms | 2026-11-18 |
| NCT03767244Phase 3Janssen Research & Development, LLCA Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy | 2026-12-01 |
| NCT06970847Phase 3Clarity Pharmaceuticals Ltd64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer | 2026-12-31 |
| NCT02446405Phase 3University of SydneyEnzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer | 2026-12-31 |
| NCT07427043Phase 3Brigham and Women's HospitalRobotic Opioid-free Prostatectomy Enhanced Strategy (ROPES) | 2026-12-31 |
Add all 338 to your calendar (.ics) → With an account.
Among the 3,595 studies in Prostatic Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to compare the effects, good and/or bad of two treatment methods on subjects and their cancer.
Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease. The benefit of the combination with androgen suppression is not completely understood. This study will compare the use of hypofraction proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Proton Radiation Total Dose=70 Gy(RBE) OR High Dose Radiation with IMRT Alone=81 Gy OR Intraoperative LDR Brachytherapy and IMRT=45 Gy
Radiation: Radiation
Androgen Suppression Therapy x 6 months + Radiation
Radiation: Radiation · Drug: Androgen Suppression Therapy
Consists of: 1. Conformal Proton Radiation Dose: 2.5 Gy (RBE) five days a week in 28 treatments over 5.5-6.5 weeks (total dose: 70 Gy (RBE)) 2. High Dose Radiation with IMRT alone: 1.8 Gy five days a week in 45 treatments over 9-10 weeks (total dose: 81 Gy) 3. Intraoperative LDR Brachytherapy and IMRT: 100Gy Pad103 implant and IMRT 1.8 Gy five days a week in 25 treatments over 5-6 weeks (total dose: 45 Gy)
Androgen suppression will begin 8 - 10 weeks prior to the start of RT for a total of 6 (+/- 2) months. Luteinizing Hormone-Releasing Hormone (LHRH) agonist therapy will consist of analogs approved by the FDA (or by Health Canada for Canadian institutions)
Also known as: leuprolide, goserelin, buserelin, or triptorelin
Morbidity Outcomes
To determine if androgen suppression along with radiation therapy will result in a higher freedom from failure (FFF) than radiation therapy without androgen suppression. Freedom from failure (FFF): The events for FFF will be the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA ≥ 2 ng/ml over the current nadir PSA) (45) discounting bounces per investigator discretion, or the start of salvage therapy including androgen suppression
Time frame: after the initial 100 patients have had a median follow up of at least three years and then every year.
Frequency and severity of grade 2 or higher GU and GI toxicity
Assessment of grade 2 or higher GU and GI toxicity using CTCAE 4.0 criteria
Time frame: At 6 months
Frequency and severity of GI and GU toxicity
Time frame: At 3 years
Incidence of quality of life issues
Time frame: At completion of radiation therapy
Incidence of Freedom from biochemical failure (FFBF)
Time frame: At 5 years
Incidence of clinical failure: local and/or distant
Time frame: At 5 years
Incidence of salvage Androgen Suppression use (SAD)
Time frame: At 5 years
Incidence of progression free survival: using clinical, biochemical and SAD as events
Time frame: At 5 years
Incidence of overall survival
Time frame: At 5 years
Incidence of disease-specific survival
Time frame: At 5 years
Correlate pathologic and radiologic findings with outcomes
Time frame: At 5 years
Correlate PSA and free PSA levels with outcomes
Time frame: At 5 years
Correlate testosterone levels and variation with proton therapy and outcomes
Time frame: At 5 years
Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity
Time frame: At 3 years
The record gives a start of Jan 2012 and a primary completion of Dec 2027. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Proton Collaborative Group