Phase 3 Prostate Cancer Trial, Recruiting NCT04654338 Sponsor: Sunnybrook Health Sciences Centre Condition: Prostate Cancer
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Phase 3 Prostate Cancer Trial, Recruiting

NCT04654338
Recruiting Phase 3

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 (a specific type called adenocarcinoma), confirmed through a tissue sample analysis
  • People whose cancer is considered low risk, meaning the cancer is contained within or close to the prostate, has a low grade group score (grade group 1), and a PSA level below 10 ng/ml
  • People whose cancer is considered favorable intermediate risk, meaning only one of the following applies: cancer has grown to a certain stage (T2c), a slightly higher grade group score (grade group 2), or a PSA level between 10 and 20 ng/ml — and no more than 50% of the tissue samples taken during biopsy contain cancer
  • People whose prostate is smaller than 60cc in size, as measured by ultrasound, CT scan, or MRI
  • People who are able to undergo an MRI scan
  • People who are willing and able to give written consent to participate

Who may not be able to join:

  • People whose cancer has spread to the lymph nodes or other parts of the body
  • People who have previously had radiotherapy to the pelvic area
  • People who have previously had prostate surgery, including procedures to remove the prostate, a procedure called transurethral resection of the prostate (TURP), or a treatment called HIFU
  • People who are currently using hormone therapy to reduce testosterone (known as androgen deprivation therapy) — note that a separate type of medication called 5-alpha-reductase inhibitors is permitted
  • People who have significant urinary problems before the trial, based on a symptom score above 15 on a standard questionnaire (confirm with trial site)
  • People who have a medical condition that would make standard prostate radiotherapy unsafe, such as certain connective tissue diseases or inflammatory bowel disease
  • People who have serious health conditions that would make it unsafe to undergo a general anaesthetic

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 6 July 2026
Phase 3: approximately ~65% 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: Andrew Loblaw, MD, Sunnybrook Health Sciences Centre

Phone: 416-480-6100

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 3
Registry
ClinicalTrials.gov
Start date
29 July 2020
Est. completion
29 January 2024

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Acute Toxicities

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: 6 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