Recruiting
Phase 2

Post-Operative RT

Sponsor:

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

Code:

NCT04249154

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

Eligard

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT04249154

Start date

Sep 3, 2019

Status verified date

Jun, 2025

Completion date

Dec 15, 2027

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

77 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Eligard

Eligard dose of 22.5mg given, 50Gy in 20 treatments of radiation therapy to start 12 weeks after first injection concurrent with second injection of Eligard

Primary outcome measure

  • Acute Patient Reported Morbidity in genito-urinary and gastrointestinal toxicity [ Time Frame: Up to 90 days after the end of radiation treatment ]

Central Contacts and Locations

Central contacts

Fabio Cury, MD

514-934-4400fabio.cury@muhc.mcgill.ca

Marianna Perna, CCRP

514-934-1934marianna.perna@muhc.mcgill.ca

Locations

McGill University Health Centre- Cedars Cancer Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Fabio Cury, M.D.

514-934-1934fabio.cury@muhc.mcgill.ca

Marianna Perna, CCRP

514-934-1934marianna.perna@muhc.mcgill.ca

McGill University Health Centre-Cedars Cancer Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Marianna Perna

514-934-1934marianna.perna@muhc.mcgill.ca

Tatiana Carvalho

514-934-1934tatiana.carvalho@muhc.mcgill.ca

Principal Investigator:

Fabio Cury, MD

More Information

Sponsor

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

Last update posted

Jun 25, 2025

Last verified

Jun, 2025

Keywords

  • Eligard
  • Post-Operative Hypofractionation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2025-06-25.