Can a shorter, stronger radiation course beat standard therapy for High-Risk prostate cancer?
NCT ID NCT02303327
First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether a shorter course of higher-dose radiation can match or improve upon standard pelvic radiation plus a brachytherapy boost for men with high-risk prostate cancer. Participants also receive hormone therapy for 28 months. The study compares side effects and cancer control between the two approaches.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy (external beam radiation therapy and high-dose-rate brachytherapy boost) plus androgen deprivation therapy
- What this could lead to
- If one approach proves safer or more effective, it could become a new standard treatment for high-risk prostate cancer, potentially reducing side effects or improving cancer control.
- What could go wrong
- This is a phase 3 trial, but results may not show a clear advantage for either arm. Both treatments carry risks of urinary, bowel, and sexual side effects from radiation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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307 people
The number who actually took part.
- Start date
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Jan 2015
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate diagnosed within 6 months prior to randomization, (if longer than 6 months, needs to be approved by the PI). * Clinical stage including at least one of the following: T3 or T4, Gleason Score \> 8, and/ or Prostate-specific antigen (PSA) \> 20 (ng/ml or μg/L). * Pelvic and para-aortic lymph nodes must be negative on CT scan or MRI of the abdomen and pelvis performed within 12 (recommended time limit, may exceed in certain cases) weeks prior to randomization. For patients who have started androgen suppression prior to randomization, CT or MRI may be done after start of therapy, provided it is done no more than 28 days following start of androgen suppression therapy (any lymph node appearing \> 1.5 cm on CT or MRI must be histologically negative by either needle aspirate or lymph node dissection performed within 12 weeks prior to randomization). * Investigations, including chest x-ray (CXR is recommended and not mandatory) CT scan and bone scan (with radiographs of suspicious areas) have been performed within 12 weeks (recommended time limit) prior to randomization and are negative for metastases. For patients who have started androgen suppression prior to randomization, bone scan may be done up to and including 28 days after the commencement of therapy. * Patients will have had a PSA test done at the time of diagnosis. This PSA test could be repeated within 28 days prior to randomization. The PSA value used to confirm high risk disease and the value to be entered on the eligibility checklist must be the higher of these two values. These criteria will be the same regardless of whether or not the patient has initiated hormone therapy prior to randomization. * The patient may have received prior androgen suppression therapy provided that androgen suppression therapy commenced no more than 28 days prior to randomization. * The patient must not have received any cytotoxic anticancer therapy for prostate cancer prior to randomization. Patients may have received treatment with a 5-alpha-reductase inhibitor (e.g. Finasteride) for benign prostatic hypertrophy (BPH), which must have been discontinued prior to the randomization. * ECOG performance status must be 0 or 1. * Hematology and Biochemistry: Laboratory requirements have been done within 28-42 days prior to randomization: hemoglobin \> 100 g/L, absolute Neutrophils \> 1.5 x 109/L, platelets \> 100 x 109/L, serum creatinine \< 1.5 x ULN Exclusion Criteria: * Patients with a history of other malignancies, except: non-melanoma skin cancer; or other solid tumours curatively treated with no evidence of disease for \> 5 years. * The presence of small-cell or transitional-cell carcinoma in the biopsy specimen. * Patients who had previous chemotherapy for carcinoma of the prostate. * Patients who had prior surgical treatment for carcinoma of the prostate apart from trans-urethral resection, including bilateral orchiectomy. * Patients with any contraindication to pelvic radiotherapy: including, but not limited to, previous pelvic radiotherapy. Inflammatory bowel disease (at the discretion of the treating oncologist) or severe bladder irritability. * Patients with serious non malignant disease resulting in a life expectancy less than 3 years. * Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including active uncontrolled infection and significant cardiac dysfunction. Patients with medical conditions that would contraindicate the treatment regimen outlined in the protocol \[e.g. intake of study drugs\]. * Known hypersensitivity to any protocol-indicated study medications. * Presence of bilateral hip replacement prostheses. * Patients with history of severe congestive heart failure will not be eligible. * Patients with congenital long QT syndrome or patients taking Class IA, Class III or Class IC anti-arrhythmic medications will require a cardiologist's evaluation prior to eligibility assessment. Patients with cardiovascular diseases can be included as long as the benefits of androgen deprivation therapy outweigh the potential risk of cardiovascular events.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
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CHUM Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
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CHUQ, L'Hôtel-Dieu de Québec
Québec, Quebec, G1R 2J6, Canada
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CHUS - Hôpital Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
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Centre Hospitalier des Vallées de l'Outaouais, Hôpital de Gatineau
Gatineau, Quebec, J8P 7H2, Canada
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Centre Hospitalier régional de Trois-Rivières
Trois-Rivières, Quebec, G8Z 3R9, Canada
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Centre de santé Rimouski-Neigette
Rimouski, Quebec, G5L 5T1, Canada
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Eastern Health
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
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Jewish General Hospital, McGill University
Montreal, Quebec, H3T 1E2, Canada
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Lawson Health Research Institute
London, Ontario, N6C 2R5, Canada
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Montréal General Hospital
Montreal, Quebec, H3G 1A4, Canada
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Windsor Regional Hospital
Windsor, Ontario, N8W2X3, Canada
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Other studies related to the condition(s) this trial covers.
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