Hypofractionated radiation therapy and hormone treatment for prostate cancer after surgery
Postoperative Hypofractionated Radiation Therapy and Hormonal Therapy in Patients With Prostate Cancer: A Phase II Trial
PHASE2 · McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT04249154
This study is testing if a new type of radiation therapy combined with hormone treatment can help men with high-risk prostate cancer feel better and reduce the chances of their cancer coming back after surgery.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 77 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre (other) |
| Drugs / interventions | Chemotherapy |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Trial ID | NCT04249154 on ClinicalTrials.gov |
What this trial studies
This Phase 2 trial investigates the effectiveness of hypofractionated radiation therapy combined with androgen deprivation therapy in patients with high-risk prostate cancer following radical prostatectomy. The study aims to assess the toxicity and potential benefits of this treatment approach in reducing the risk of biochemical failure. Participants will receive the treatment and be monitored for side effects and treatment outcomes. The trial is designed to provide insights into the optimal timing and method of radiation therapy for patients at high risk of recurrence.
Who should consider this trial
Good fit: Ideal candidates are men with histologically proven high-risk prostate cancer who have undergone radical prostatectomy and have specific pathological features indicating a higher risk of recurrence.
Not a fit: Patients with low-risk prostate cancer or those who have not undergone radical prostatectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of cancer recurrence and improve survival rates for patients with high-risk prostate cancer.
How similar studies have performed: Previous studies have shown promising results with hypofractionated radiation therapy in lower-risk populations, but this specific approach in high-risk patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically proven high risk (any of the following risk factors: surgical positive margins; extra-capsular extension; seminal vesicle involvement, Gleason score \>7) adenocarcinoma of the prostate after a radical prostatectomy as primary treatment (adjuvant group), with pathologically negative lymph nodes dissection or clinically negative lymph nodes by imaging \[pelvic and abdominal computed tomography (CT) scan, or magnetic resonance imaging (MRI)\]. Lymphadenectomy is not mandatory. Any type of prostatectomy will be permitted. For this group of patients, the PSA level at time of entry must be below 0.4 ng/ml * Histologically proven adenocarcinoma after a radical prostatectomy with pathologically negative lymph nodes (lymphadenectomy is not mandatory) or clinically negative lymph nodes by imaging (pelvic and abdominal CT scan, or MRI or) and evidence of biochemical failure (defined as two consecutives rises of the PSA, at any PSA level). PSA upper limit post-prostatectomy must be below 2.0 ng/ml (salvage group). Any type of prostatectomy will be permitted * Negative bone metastases proven by bone scan. The use of proton emission tomography (PET) fluoride is allowed * History and physical examination (including digital rectal exam) within 90 days prior of registration * Adequate marrow reserve defined as: Hemoglobin ≥ 10 g/dl (patients may be transfused in order to achieve this level); Platelets ≥ 100 000 cells/mm3 and a white blood cell count of ≥ 4000 cells/ml3 * AST or ALT \<2 x the upper limit of normal * PSA and testosterone levels within one month of registration Age ≥ 18 * Zubrod Performance Status 0-1 * Patients must sign a study-specific consent form Exclusion Criteria: * Previous exposure to androgen deprivation * Chemotherapy before or after prostatectomy * Prior pelvic radiotherapy * Previous malignancies (except non-melanomatous skin cancer) unless disease-free \>5 years * Severe, active medical condition that makes the use of any of the therapies of the study not recommended
Where this trial is running
Montreal, Quebec and 1 other locations
- McGill University Health Centre- Cedars Cancer Centre — Montreal, Quebec, Canada (RECRUITING)
- McGill University Health Centre-Cedars Cancer Centre — Montreal, Quebec, Canada (RECRUITING)
Study contacts
- Principal investigator: Fabio Cury, MD — Radiation Oncologist
- Study coordinator: Fabio Cury, MD
- Email: fabio.cury@muhc.mcgill.ca
- Phone: 514-934-4400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Eligard, Post-Operative Hypofractionation