Postop Hypofractionated Radiation Therapy and LHRH in Patients With Prostate Cancer

Status

Recruiting

Phase

Phase 2

Enrollment

77 participants (estimated)

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre · Other

Design

Allocation not applicable · Open label (no masking)

Countries

1 country

Canada

Start

3 Sept 2019

Primary completion

15 Dec 2026 (estimated)

Completion

15 Dec 2027 (estimated)

First posted

30 Jan 2020

Last update posted

25 Jun 2025

Conditions

Prostate Cancer

Prostate cancer is the second most common cancer among Canadian men of which approximately 20-30% present with high-risk tumour characteristic. Although surgery can be curative in patients evidencing pathological high-risk disease (extracapsular extension, seminal vesicle involvement, positive surgical margins), a large proportion will develop biochemical failure within years from the surgical procedure. The failure rate is even more pronounced in those patients that present with high prostate specific antigen (PSA) levels, pT3 disease, positive margins and Gleason score ≥8 with an estimated 75% failure rate at 10 years. Post-operative radiotherapy (RT) has been shown in three randomized trials to significantly decrease the biochemical failure rate and in one of the trials a survival benefit was also seen with the addition of post-operative RT and is considered by many investigators standard therapy in patients with pathological high-risks factors even in absence of biochemical failure.

• Other

  Post-op IMRT & hormonal therapy

  The protocol is designed to recruit patients who have undergone prostatectomy and high risk features of the disease were found post-operatively or for patients that, after prostatectomy, a PSA rise has been documented will be enrolled in the Phase II trial. Patients will receive Eligard injection 8-12 weeks before starting radiation. The second injection is given 12 weeks after the first one concomitant with radiation therapy.

1. Acute Patient Reported Morbidity in genito-urinary and gastrointestinal toxicity

   Time frame · Up to 90 days after the end of radiation treatment

   Registry description

   Number of Participants With Treatment-Related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events v.5.0 (CTCAE v5.0), Change From Baseline in genito-urinary and gastrointestinal toxicity up to 12 Weeks. Assessments will be collected at baseline and at the end of radiotherapy treatment and in follow-up.