NCT Number: NCT07483658
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.
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
Interested in participating?
Request Info18 year and older
Male
Interventional
Not applicable
Gatineau Hospital, Gatineau, Quebec, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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.
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.
Time frame: Up to 10 years post-treatment.
Time from the end of radiotherapy to biochemical recurrence, defined as PSA ≥ 0.2 ng/mL and rising.
Time frame: Up to 10 years post-treatment.
Time from the end of radiotherapy to biochemical recurrence, metastatic recurrence, or death from any cause, whichever occurs first.
Time frame: Up to 10 years post-treatment.
Time from the end of radiotherapy to the first occurrence of metastatic disease or death from any cause.
Time frame: Up to 10 years post-treatment.
Time from the end of radiotherapy to the start of systemic therapy (e.g., ADT, ARPis, chemotherapy).
Time frame: Up to 10 years post-treatment.
Time from the end of radiotherapy to death from any cause.
Time frame: Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.
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.
Time frame: Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.
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.
Time frame: Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.
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.
Contact information is provided by the study sponsor or research team.
CHU de Quebec-Universite Laval
Other
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)
Acronym: HYP-OP-RT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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