Phase 2 Prostate Cancer Trial, Recruiting NCT04249154 Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT04249154
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with prostate cancer (confirmed by tissue testing) and have already had their prostate removed as their main treatment, and whose cancer has one or more high-risk features — such as cancer cells found at the edges of the removed tissue, cancer that had spread beyond the prostate capsule, cancer involving the seminal vesicles, or a Gleason score greater than 7 — with no cancer found in the lymph nodes (either by surgical removal and testing, or by CT or MRI scan), and a PSA level below 0.4 ng/ml at the time of joining
  • People who have had their prostate surgically removed, have no cancer in their lymph nodes (confirmed by surgery or CT/MRI scan), and whose PSA level has risen on two separate tests at any level, with a PSA no higher than 2.0 ng/ml after surgery
  • People with no bone metastases (cancer spread to the bones), confirmed by a bone scan or PET fluoride scan
  • People who have had a full physical examination, including a digital rectal exam, within the 90 days before registering for the trial
  • People with adequate blood counts — specifically, haemoglobin of at least 10 g/dl, platelets of at least 100,000 cells/mm³, and white blood cell count of at least 4,000 cells/ml³ (confirm with trial site regarding transfusion allowance)
  • People with liver enzyme levels (AST or ALT) within an acceptable range — less than twice the upper limit of normal
  • People who have had PSA and testosterone levels tested within one month before registration
  • People aged 18 or older
  • People with a good general performance level, rated 0 or 1 on the Zubrod scale (meaning fully active or able to carry out light activity) (confirm with trial site)
  • People who are willing to sign the trial-specific consent form

Who may not be able to join:

  • People who have previously received hormone therapy to reduce androgen (male hormone) levels
  • People who have received chemotherapy at any point before or after their prostate surgery
  • People who have previously had radiotherapy to the pelvic area
  • People who have had another cancer in the past, unless they have been free of that cancer for more than 5 years — an exception may apply for certain non-melanoma skin cancers
  • People who have a serious or active medical condition that would make any of the treatments used in this trial unsafe or unsuitable for them

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 8 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Fabio Cury, MD, Radiation Oncologist

Phone: 514-934-4400

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Registry
ClinicalTrials.gov
Start date
3 September 2019
Est. completion
15 December 2026

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Acute Patient Reported Morbidity in genito-urinary and gastrointestinal toxicity

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov