Hypofractionated radiation therapy and hormone treatment for prostate cancer after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.