Reccurent/Metastatic Solid Tumor DiseaseHYP-OP-RTNCT07483658

Non-inferiority Study Comparing Salvage Pelvic Radiotherapy in 25 Fractions (62.5 Gy/25) Versus 20 Fractions (52.5 Gy/20) for Recurrent Prostate Cancer After Surgery.

A study testing Standard Fractionation Post-Operative Salvage Radiotherapy (25 fractions), Hypofractionated Post-Operative Salvage Radiotherapy (20 fractions) and Androgen Deprivation Therapy (ADT) in people with Reccurent/Metastatic Solid Tumor Disease and Prostate Cancer (Post Prostatectomy), run by CHU de Quebec-Universite Laval at 4 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Study Overview This research compares two types of post-operative salvage radiotherapy (SRT) for men with prostate cancer who have had surgery but show signs of recurrence (detectable PSA). The goal is to see if a shorter treatment schedule is as safe and effective as the standard schedule. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Reccurent/Metastatic Solid Tumor Disease, Prostate Cancer (Post Prostatectomy), Prostate Cancer
What is being tested?: Standard Fractionation Post-Operative Salvage Radiotherapy (25 fractions), Hypofractionated Post-Operative Salvage Radiotherapy (20 fractions) and Androgen Deprivation Therapy (ADT)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 434 participants
Where: 4 sitesCanada
Study dates: 13 May 2026to Feb 2036
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically confirmed prostate adenocarcinoma.
Prior radical prostatectomy with detectable PSA (≥0.2 ng/mL).
No evidence of distant metastasis (confirmed via bone scan and CT/MRI or TEP-PSMA if PSA is above 0.5 ng /ml).
Patient with Nodal recurrence within the pelvis are eligible
ECOG performance status 0-2.
Age ≥ 18 years.
Adequate baseline renal, hepatic, and hematologic function.

Who cannot join

Prior pelvic radiotherapy.
Macroscopic local relapse on imaging
Presence of metastatic disease.
Active inflammatory bowel disease or other GI conditions predisposing to radiation toxicity.
Uncontrolled comorbidities affecting study participation.
Prior systemic therapy for recurrent prostate cancer (except ADT within 6 months).

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Eric Vigneault, MD, MSc contact

418 691-5264

eric.vigneault.med@ssss.gouv.qc.ca

Damien Carignan, PhD contact

418 525-4444 ext. 67854

damien.carignan@crchudequebec.ulaval.ca

Canada4 sites, 4 recruiting

Gatineau Hospital
Gatineau, Quebec
Steven Tisseverasinghe, MD, 819-966-6100, steven.tisseverasinghe.med@ssss.gouv.qc.ca
Not yet recruiting
Hôpital Général Juif
Montreal, Quebec, H3T 1E2
Tamim Niazi, MD, 514-340-8288, tniazi@mcgill.ca
Not yet recruiting
McGill University Health Centre
Montreal, Quebec, H4A 3J1
James MG Tsui, MS, PhD, 514-934-4400, james.tsui@mcgill.ca
Not yet recruiting
CHU de Québec-Université Laval
Québec, Quebec, G1G 5X1
Eric Vigneault, MD, MSc, 418 691-5264, eric.vigneault.med@ssss.gouv.qc.ca
Damien Carignan, PhD, 418 525-4444 ext. 67853, damien.carignan@crchudequebec.ulaval.ca
Recruiting

Other trials in Canada

About this study

Official title: Non-Inferiority Study Comparing Hypofractionated Post-Operative Salvage Radiotherapy Regimens: 45/62.5 Gy in 25 Fractions vs. 43/52.5 Gy in 20 Fractions for Grade 2+ GU or GI Toxicity (HYP-OP-RT)

Why is this study important? After prostate surgery, cancer can return in up to 70-80% of high-risk patients. Radiotherapy helps control this, but the best way to deliver it-especially the number of sessions and whether to treat the pelvic area-is still being studied. Shorter treatments could mean less time in therapy and better quality of life, if such treatments are proven safe.

What is being compared?

Standard treatment (Arm A):

25 sessions (about 5 weeks) Prostate bed: 62.5 Gy Pelvis: 45 Gy

Shorter treatment (Arm B):

20 sessions (about 4 weeks) Prostate bed: 52.5 Gy Pelvis: 43 Gy

Both groups may also receive hormone therapy (ADT) for 6-24 months.

Main Goal To check if the shorter treatment causes no more side effects (urinary or bowel problems) than the standard treatment, while keeping cancer control similar.

Other Things to be Measured

Cancer control (PSA levels, spread of disease) Survival Quality of life (urinary, bowel, sexual health questionnaires)

Who can join?

Men who:

Had prostate surgery Have a detectable PSA (≥0.2 ng/mL) No distant metastasis Are in good general health (ECOG 0-2)

How long will the study last?

About 12 years total:

2 years to enroll patients 10 years of follow-up

Conditions: Reccurent/Metastatic Solid Tumor Disease, Prostate Cancer (Post Prostatectomy), Prostate Cancer, Prostatic Neoplasms, Neoplasm Recurrence, Local, Biochemical Recurrence of Malignant Neoplasm of Prostate
Being tested: Standard Fractionation Post-Operative Salvage Radiotherapy (25 fractions), Hypofractionated Post-Operative Salvage Radiotherapy (20 fractions), Androgen Deprivation Therapy (ADT)
Keywords: Radiotherapy, Adjuvant, Radiotherapy, Intensity-Modulated, Radiotherapy, High-Dose Hypofractionated, Pelvic Radiotherapy, Androgen Deprivation Therapy, Randomized Controlled Trials, Noninferiority Trials, Quality of Life, Treatment Outcome, Gastrointestinal Diseases / chemically induced, Urinary Tract Diseases / chemically induced, Radiation Injuries
Medical subject headings: Prostatic Neoplasms, Neoplasm Recurrence, Local, Gastrointestinal Diseases, Urologic Diseases, Radiation Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard Fractionation Post-Operative Salvage Radiotherapy (25 fractions)Radiation
Type: Radiation Description: External beam radiotherapy delivered to the prostate bed and pelvis using VMAT/IMRT techniques.
Dose and Schedule:
Prostate bed: 62.5 Gy in 25 fractions Pelvis: 45 Gy in 25 fractions Duration: Approximately 5 weeks
Hypofractionated Post-Operative Salvage Radiotherapy (20 fractions)Radiation
Type: Radiation Description: External beam radiotherapy delivered to the prostate bed and pelvis using VMAT/IMRT techniques.
Dose and Schedule:
Prostate bed: 52.5 Gy in 20 fractions Pelvis: 43 Gy in 20 fractions Duration: Approximately 4 weeks
Androgen Deprivation Therapy (ADT)Drug
Type: Drug Description: Hormonal therapy with a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., goserelin) ± short-term anti-androgen.
Duration: 6 to 24 months, at physician's discretion. Additional Notes: Patients with pelvic nodal disease may receive abiraterone and prednisone for 24 months as per STAMPEDE protocol.

Study groups in NCT07483658
Study group	Role	What they receive
Arm A	Active comparator	Prostate bed 62.5 Gy / 25 Pelvis 45 Gy / 25 (+/-55 Gy/25) ADT Receives: Radiation: Standard Fractionation Post-Operative Salvage Radiotherapy (25 fractions); Drug: Androgen Deprivation Therapy (ADT)
Arm B	Experimental	Prostate bed 52.5 Gy / 20 Pelvis 43 Gy / 20 (+/-52 Gy/20) ADT Receives: Radiation: Hypofractionated Post-Operative Salvage Radiotherapy (20 fractions); Drug: Androgen Deprivation Therapy (ADT)

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Grade 2 or Higher Genitourinary (GU) or Gastrointestinal (GI) Toxicity
The proportion of patients experiencing Grade 2 or higher GU or GI adverse events, assessed according to CTCAE v5.0 criteria, following post-operative salvage radiotherapy. This outcome measures treatment-related toxicity in both study arms.
Measured: Within 24 months after completion of radiotherapy.

Secondary outcomes (8)

Biochemical Progression-Free Survival (bPFS)
Time from the end of radiotherapy to biochemical recurrence, defined as PSA ≥ 0.2 ng/mL and rising.
Measured: Up to 10 years post-treatment.
Progression-Free Survival (PFS)
Time from the end of radiotherapy to biochemical recurrence, metastatic recurrence, or death from any cause, whichever occurs first.
Measured: Up to 10 years post-treatment.
Metastasis-Free Survival (MFS)
Time from the end of radiotherapy to the first occurrence of metastatic disease or death from any cause.
Measured: Up to 10 years post-treatment.
Time to Initiation of Systemic Salvage Therapy
Time from the end of radiotherapy to the start of systemic therapy (e.g., ADT, ARPis, chemotherapy).
Measured: Up to 10 years post-treatment.
Overall Survival (OS)
Time from the end of radiotherapy to death from any cause.
Measured: Up to 10 years post-treatment.
Expanded Prostate Cancer Index Composite-26 (EPIC-26)
EPIC-26 is a validated 26-item, patient-reported questionnaire used to evaluate health-related quality of life, specifically urinary, bowel, sexual, and hormonal symptoms, following prostate cancer treatment. Responses are converted to a 0-100 scale. A higher score indicates better function or less bother.
Measured: Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.
International Prostate Symptom Score (IPSS)
IPSS is an 8-question tool evaluating Lower Urinary Tract Symptoms in prostate cancer and benign prostatic hyperplasia. Scores of 0-7 are mild, 8-19 moderate, and 20-35 severe. It measures frequency, urgency, straining, and nocturia, aiding treatment monitoring.
Measured: Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.
Functional Assessment of Cancer Therapy - Prostate (FACT-P)
The FACT-P is a 39-item validated instrument used to evaluate Health-Related Quality of Life (HRQoL) specifically in prostate cancer patients. Each item is rated on a 5-point Likert scale (0 to 4). The total score ranges from 0 to 156, where a higher score indicates a better quality of life.
Measured: Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 2026Feb 2036

First posted19 Mar 2026
Study start13 May 2026
Primary completionDec 2029 (estimated)
Study completionFeb 2036 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Reccurent/Metastatic Solid Tumor DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 434 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07483658
Sponsor's protocol ID: MP-20-2026-8430
Other IDs: PCS XIII
Acronym: HYP-OP-RT
Status last verified: Jun 2026
First submitted: 13 Mar 2026
Last updated: 1 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Institutional policies are against sharing IPD.

Publications

Pollack A, Karrison TG, Balogh AG, Gomella LG, Low DA, Bruner DW, Wefel JS, Martin AG, Michalski JM, Angyalfi SJ, Lukka H, Faria SL, Rodrigues GB, Beauchemin MC, Lee RJ, Seaward SA, Allen AM, Monitto DC, Seiferheld W, Sartor O, Feng F, Sandler HM. The addition of androgen deprivation therapy and pelvic lymph node treatment to prostate bed salvage radiotherapy (NRG Oncology/RTOG 0534 SPPORT): an international, multicentre, randomised phase 3 trial. Lancet. 2022 May 14;399(10338):1886-1901. doi: 10.1016/S0140-6736(21)01790-6.
PubMed 35569466
Shipley WU, Seiferheld W, Lukka HR, Major PP, Heney NM, Grignon DJ, Sartor O, Patel MP, Bahary JP, Zietman AL, Pisansky TM, Zeitzer KL, Lawton CA, Feng FY, Lovett RD, Balogh AG, Souhami L, Rosenthal SA, Kerlin KJ, Dignam JJ, Pugh SL, Sandler HM; NRG Oncology RTOG. Radiation with or without Antiandrogen Therapy in Recurrent Prostate Cancer. N Engl J Med. 2017 Feb 2;376(5):417-428. doi: 10.1056/NEJMoa1607529.
PubMed 28146658
Parker CC, Kynaston H, Cook AD, Clarke NW, Catton CN, Cross WR, Petersen PM, Persad RA, Pugh CA, Saad F, Logue J, Payne H, Bower LC, Brawley C, Rauchenberger M, Barkati M, Bottomley DM, Brasso K, Chung HT, Chung PWM, Conroy R, Falconer A, Ford V, Goh CL, Heath CM, James ND, Kim-Sing C, Kodavatiganti R, Malone SC, Morris SL, Nabid A, Ong AD, Raman R, Rodda S, Wells P, Worlding J, Parulekar WR, Parmar MKB, Sydes MR; RADICALS investigators. Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial. Lancet. 2024 Jun 1;403(10442):2416-2425. doi: 10.1016/S0140-6736(24)00549-X. Epub 2024 May 16.
PubMed 38763153
Petersen PM, Cook AD, Sydes MR, Clarke N, Cross W, Kynaston H, Logue J, Neville P; Patient Representative; Payne H, Parmar MKB, Parulekar W, Persad R, Saad F, Stirling A, Parker CC, Catton C. Salvage Radiation Therapy After Radical Prostatectomy: Analysis of Toxicity by Dose-Fractionation in the RADICALS-RT Trial. Int J Radiat Oncol Biol Phys. 2023 Nov 1;117(3):624-629. doi: 10.1016/j.ijrobp.2023.04.032. Epub 2023 May 6.
PubMed 37150260
Buyyounouski MK, Pugh SL, Chen RC, Mann MJ, Kudchadker RJ, Konski AA, Mian OY, Michalski JM, Vigneault E, Valicenti RK, Barkati M, Lawton CAF, Potters L, Monitto DC, Kittel JA, Schroeder TM, Hannan R, Duncan CE, Rodgers JP, Feng F, Sandler HM. Noninferiority of Hypofractionated vs Conventional Postprostatectomy Radiotherapy for Genitourinary and Gastrointestinal Symptoms: The NRG-GU003 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2024 May 1;10(5):584-591. doi: 10.1001/jamaoncol.2023.7291.
PubMed 38483412
Attard G, Murphy L, Clarke NW, Cross W, Jones RJ, Parker CC, Gillessen S, Cook A, Brawley C, Amos CL, Atako N, Pugh C, Buckner M, Chowdhury S, Malik Z, Russell JM, Gilson C, Rush H, Bowen J, Lydon A, Pedley I, O'Sullivan JM, Birtle A, Gale J, Srihari N, Thomas C, Tanguay J, Wagstaff J, Das P, Gray E, Alzoueb M, Parikh O, Robinson A, Syndikus I, Wylie J, Zarkar A, Thalmann G, de Bono JS, Dearnaley DP, Mason MD, Gilbert D, Langley RE, Millman R, Matheson D, Sydes MR, Brown LC, Parmar MKB, James ND; Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) investigators. Abiraterone acetate and prednisolone with or without enzalutamide for high-risk non-metastatic prostate cancer: a meta-analysis of primary results from two randomised controlled phase 3 trials of the STAMPEDE platform protocol. Lancet. 2022 Jan 29;399(10323):447-460. doi: 10.1016/S0140-6736(21)02437-5. Epub 2021 Dec 23.
PubMed 34953525

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-Inferiority Study Comparing Hypofractionated Post-Operative Salvage Radiotherapy Regimens: 45/62.5 Gy in 25 Fractions vs. 43/52.5 Gy in 20 Fractions for Grade 2+ GU or GI Toxicity (HYP-OP-RT)
ClinicalTrials.gov ID: NCT07483658
Acronym / sponsor ID: HYP-OP-RT / MP-20-2026-8430
Conditions: Reccurent/Metastatic Solid Tumor Disease, Prostate Cancer (Post Prostatectomy), Prostate Cancer, Prostatic Neoplasms, Neoplasm Recurrence, Local, Biochemical Recurrence of Malignant Neoplasm of Prostate
Keywords: Radiotherapy, Adjuvant, Radiotherapy, Intensity-Modulated, Radiotherapy, High-Dose Hypofractionated, Pelvic Radiotherapy, Androgen Deprivation Therapy, Randomized Controlled Trials, Noninferiority Trials, Quality of Life
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 434 participants (estimated)
Lead sponsor: CHU de Quebec-Universite LavalUniversity, hospital or other
Collaborators: TerSera Therapeutics LLC
Study start: 13 May 2026 (actual)
Primary completion: Dec 2029 (estimated)
Study completion: Feb 2036 (estimated)
First posted: 19 Mar 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

What is being compared?

Standard treatment (Arm A):

25 sessions (about 5 weeks) Prostate bed: 62.5 Gy Pelvis: 45 Gy

Shorter treatment (Arm B):

20 sessions (about 4 weeks) Prostate bed: 52.5 Gy Pelvis: 43 Gy

Both groups may also receive hormone therapy (ADT) for 6-24 months.

Main Goal To check if the shorter treatment causes no more side effects (urinary or bowel problems) than the standard treatment, while keeping cancer control similar.

Other Things to be Measured

Cancer control (PSA levels, spread of disease) Survival Quality of life (urinary, bowel, sexual health questionnaires)

Who can join?

Men who:

Had prostate surgery Have a detectable PSA (≥0.2 ng/mL) No distant metastasis Are in good general health (ECOG 0-2)

How long will the study last?

About 12 years total:

2 years to enroll patients 10 years of follow-up

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A	Active comparator	Radiation: Standard Fractionation Post-Operative Salvage Radiotherapy (25 fractions), Drug: Androgen Deprivation Therapy (ADT)Prostate bed 62.5 Gy / 25 Pelvis 45 Gy / 25 (+/-55 Gy/25) ADT
Arm B	Experimental	Radiation: Hypofractionated Post-Operative Salvage Radiotherapy (20 fractions), Drug: Androgen Deprivation Therapy (ADT)Prostate bed 52.5 Gy / 20 Pelvis 43 Gy / 20 (+/-52 Gy/20) ADT

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Histologically confirmed prostate adenocarcinoma.
Prior radical prostatectomy with detectable PSA (≥0.2 ng/mL).
No evidence of distant metastasis (confirmed via bone scan and CT/MRI or TEP-PSMA if PSA is above 0.5 ng /ml).
Patient with Nodal recurrence within the pelvis are eligible
ECOG performance status 0-2.

Key exclusion criteria (6 listed)

Prior pelvic radiotherapy.
Macroscopic local relapse on imaging
Presence of metastatic disease.
Active inflammatory bowel disease or other GI conditions predisposing to radiation toxicity.
Uncontrolled comorbidities affecting study participation.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standard Fractionation Post-Operative Salvage Radiotherapy (25 fractions)Type: Radiation Description: External beam radiotherapy delivered to the prostate bed and pelvis using VMAT/IMRT techniques. Dose and Schedule: Prostate bed: 62.5 Gy in 25 fractions Pelvis: 45 Gy in 25 fractions Duration: Approximately 5 weeks	Radiation	Arm A
Hypofractionated Post-Operative Salvage Radiotherapy (20 fractions)Type: Radiation Description: External beam radiotherapy delivered to the prostate bed and pelvis using VMAT/IMRT techniques. Dose and Schedule: Prostate bed: 52.5 Gy in 20 fractions Pelvis: 43 Gy in 20 fractions Duration: Approximately 4 weeks	Radiation	Arm B
Androgen Deprivation Therapy (ADT)Type: Drug Description: Hormonal therapy with a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., goserelin) ± short-term anti-androgen. Duration: 6 to 24 months, at physician's discretion. Additional Notes: Patients with pelvic nodal disease may receive abiraterone and prednisone for 24 months as per STAMPEDE protocol.	Drug	Arm A, Arm B

Primary outcome

Incidence of Grade 2 or Higher Genitourinary (GU) or Gastrointestinal (GI) Toxicity
Time frame: Within 24 months after completion of radiotherapy.
The proportion of patients experiencing Grade 2 or higher GU or GI adverse events, assessed according to CTCAE v5.0 criteria, following post-operative salvage radiotherapy. This outcome measures treatment-related toxicity in both study arms.

8 secondary outcomes

Biochemical Progression-Free Survival (bPFS)
Time frame: Up to 10 years post-treatment.
Progression-Free Survival (PFS)
Time frame: Up to 10 years post-treatment.
Metastasis-Free Survival (MFS)
Time frame: Up to 10 years post-treatment.
Time to Initiation of Systemic Salvage Therapy
Time frame: Up to 10 years post-treatment.
Overall Survival (OS)
Time frame: Up to 10 years post-treatment.
Expanded Prostate Cancer Index Composite-26 (EPIC-26)
Time frame: Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.
International Prostate Symptom Score (IPSS)
Time frame: Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.
Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Time frame: Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
Background: PubMed 35569466Pollack A, Karrison TG, Balogh AG, Gomella LG, Low DA, Bruner DW, Wefel JS, Martin AG, Michalski JM, Angyalfi SJ, Lukka H, Faria SL, Rodrigues GB, Beauchemin MC, Lee RJ, Seaward SA, Allen AM, Monitto DC, Seiferheld W, Sartor O, Feng F, Sandler HM. The addition of androgen deprivation therapy and pelvic lymph node treatment to prostate bed salvage radiotherapy (NRG Oncology/RTOG 0534 SPPORT): an international, multicentre, randomised phase 3 trial. Lancet. 2022 May 14;399(10338):1886-1901. doi: 10.1016/S0140-6736(21)01790-6.
Background: PubMed 28146658Shipley WU, Seiferheld W, Lukka HR, Major PP, Heney NM, Grignon DJ, Sartor O, Patel MP, Bahary JP, Zietman AL, Pisansky TM, Zeitzer KL, Lawton CA, Feng FY, Lovett RD, Balogh AG, Souhami L, Rosenthal SA, Kerlin KJ, Dignam JJ, Pugh SL, Sandler HM; NRG Oncology RTOG. Radiation with or without Antiandrogen Therapy in Recurrent Prostate Cancer. N Engl J Med. 2017 Feb 2;376(5):417-428. doi: 10.1056/NEJMoa1607529.
Background: PubMed 38763153Parker CC, Kynaston H, Cook AD, Clarke NW, Catton CN, Cross WR, Petersen PM, Persad RA, Pugh CA, Saad F, Logue J, Payne H, Bower LC, Brawley C, Rauchenberger M, Barkati M, Bottomley DM, Brasso K, Chung HT, Chung PWM, Conroy R, Falconer A, Ford V, Goh CL, Heath CM, James ND, Kim-Sing C, Kodavatiganti R, Malone SC, Morris SL, Nabid A, Ong AD, Raman R, Rodda S, Wells P, Worlding J, Parulekar WR, Parmar MKB, Sydes MR; RADICALS investigators. Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial. Lancet. 2024 Jun 1;403(10442):2416-2425. doi: 10.1016/S0140-6736(24)00549-X. Epub 2024 May 16.
Background: PubMed 37150260Petersen PM, Cook AD, Sydes MR, Clarke N, Cross W, Kynaston H, Logue J, Neville P; Patient Representative; Payne H, Parmar MKB, Parulekar W, Persad R, Saad F, Stirling A, Parker CC, Catton C. Salvage Radiation Therapy After Radical Prostatectomy: Analysis of Toxicity by Dose-Fractionation in the RADICALS-RT Trial. Int J Radiat Oncol Biol Phys. 2023 Nov 1;117(3):624-629. doi: 10.1016/j.ijrobp.2023.04.032. Epub 2023 May 6.
Background: PubMed 38483412Buyyounouski MK, Pugh SL, Chen RC, Mann MJ, Kudchadker RJ, Konski AA, Mian OY, Michalski JM, Vigneault E, Valicenti RK, Barkati M, Lawton CAF, Potters L, Monitto DC, Kittel JA, Schroeder TM, Hannan R, Duncan CE, Rodgers JP, Feng F, Sandler HM. Noninferiority of Hypofractionated vs Conventional Postprostatectomy Radiotherapy for Genitourinary and Gastrointestinal Symptoms: The NRG-GU003 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2024 May 1;10(5):584-591. doi: 10.1001/jamaoncol.2023.7291.
Background: PubMed 34953525Attard G, Murphy L, Clarke NW, Cross W, Jones RJ, Parker CC, Gillessen S, Cook A, Brawley C, Amos CL, Atako N, Pugh C, Buckner M, Chowdhury S, Malik Z, Russell JM, Gilson C, Rush H, Bowen J, Lydon A, Pedley I, O'Sullivan JM, Birtle A, Gale J, Srihari N, Thomas C, Tanguay J, Wagstaff J, Das P, Gray E, Alzoueb M, Parikh O, Robinson A, Syndikus I, Wylie J, Zarkar A, Thalmann G, de Bono JS, Dearnaley DP, Mason MD, Gilbert D, Langley RE, Millman R, Matheson D, Sydes MR, Brown LC, Parmar MKB, James ND; Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) investigators. Abiraterone acetate and prednisolone with or without enzalutamide for high-risk non-metastatic prostate cancer: a meta-analysis of primary results from two randomised controlled phase 3 trials of the STAMPEDE platform protocol. Lancet. 2022 Jan 29;399(10323):447-460. doi: 10.1016/S0140-6736(21)02437-5. Epub 2021 Dec 23.
Individual participant dataSharing planned: No. Institutional policies are against sharing IPD.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Eric Vigneault, MD, MSc contact

418 691-5264

eric.vigneault.med@ssss.gouv.qc.ca

Damien Carignan, PhD contact

418 525-4444 ext. 67854

damien.carignan@crchudequebec.ulaval.ca

Eric Vigneault, MD, MSc principal investigator

CHU de Québec-Université Laval

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eric Vigneault, MD, MSc (418 691-5264, eric.vigneault.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Grade 2 or Higher Genitourinary (GU) or Gastrointestinal (GI) Toxicity (time frame: Within 24 months after completion of radiotherapy.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07483658, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.