Phase 3 Prostate Cancer Trial, Recruiting NCT01492972 Sponsor: Proton Collaborative Group Condition: Prostate Cancer
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Phase 3 Prostate Cancer Trial, Recruiting

NCT01492972
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:

  • You have been diagnosed with prostate cancer (confirmed by a tissue sample taken within the past year) that is considered "intermediate risk" based on at least one of the following: a Gleason score of 7, a PSA level between 10 and 20, or a tumour stage of T2b–T2c.
  • Your cancer has not spread to lymph nodes or other parts of the body, based on your doctor's assessment.
  • Your prostate biopsy has been reviewed and given a Gleason score between 2 and 7 (a measure of how the cancer cells look under a microscope).
  • Your PSA blood test result was 20 ng/ml or lower, taken within the past 90 days, either before your biopsy or at least 21 days after it.
  • You are generally healthy or have only minor limitations in daily activity (confirm with trial site).
  • You are willing and able to sign a consent form approved for this study.
  • You have completed all required tests before joining, within the required timeframes.
  • You are able to begin treatment within 56 days of being enrolled in the trial.
  • You are at least 18 years old.
  • If brachytherapy (internal radiation) is being considered, your urinary symptom score must meet a specific threshold, with a slightly lower limit if you take medication to help with urination (confirm with trial site).
  • If brachytherapy is being considered, your prostate must measure less than 55cc in volume before any hormone-shrinking treatment.

Who may not be able to join:

  • You have enlarged pelvic lymph nodes (larger than 1.5 cm) unless a biopsy has confirmed they do not contain cancer.
  • You have previously had prostate surgery, including removal of the prostate, heat treatment (hyperthermia), or freezing treatment (cryosurgery).
  • You have previously had radiation therapy to the pelvic area for prostate cancer.
  • You have previously received hormone therapy to suppress testosterone for prostate cancer.
  • You currently have active rectal diverticulitis, Crohn's disease affecting the rectum, or active ulcerative colitis.
  • You have previously had chemotherapy for prostate cancer.
  • You have a history of a narrowing of the upper urethra (the tube that carries urine) that required a procedure to widen it.
  • You are currently taking blood-thinning medications such as warfarin (Coumadin), heparin, Plavix (clopidogrel), or similar drugs, unless these can be safely stopped when needed during the trial.
  • You have a serious medical, mental health, or addiction-related condition that, in your doctor's opinion, would prevent you from completing the treatment or follow-up, or from giving your own consent.
  • You have had another type of cancer in the past 5 years with less than a 50% chance of surviving 5 years (certain skin cancers are an exception — confirm with trial site).
  • You have had a heart attack within the past 6 months.

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 26 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.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Proton Collaborative Group
Registry
ClinicalTrials.gov
Start date
1 January 2012
Est. completion
1 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Morbidity Outcomes

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: 26 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