Comparing two versus five MRI-guided treatments for prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of ultra-hypofractionated radiotherapy (UHRT) compared to the standard five-fraction stereotactic ablative body radiotherapy (SABR) for men with localized prostate cancer. The study aims to determine if delivering radiation in just two fractions over two weeks can achieve similar therapeutic outcomes as the traditional five-fraction regimen. Participants will receive highly conformal radiation treatment, which is less invasive and does not require general anesthesia. The trial is designed to assess both the efficacy and tolerability of the two approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histologically confirmed prostate adenocarcinoma (centrally reviewed)
2. Low or favorable intermediate risk disease. Patient must meet one of the following categories:

   * Low risk - T1-T2b, grade group 1, AND PSA \< 10 ng/ml;
   * Favorable risk

     1. Only one of the following intermediate risk factors - cT2c, grade group 2, or PSA 10-20 ng/ml; or
     2. Grade group 3 AND PSA \< 20, AND \<cT2c AND absolute percentage pattern 4/5 is \<10%

Exclusion Criteria:

1. Androgen deprivation therapy (LHRH-agonists or antiandrogens) given or planned
2. Prior pelvic radiotherapy
3. Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
4. Diagnosis of bleeding diathesis
5. Large prostate (\>90cm3) on imaging
6. Immunosuppressive medications
7. Inflammatory bowel disease
8. Presence of dual hip prostheses
9. Contraindications to having MRI

Where it's running

• Sunnybrook Health Sciences Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Danny Vesprini, MD — Sunnybrook Health Sciences Centre
• Study coordinator: Danny Vesprini, MD
• Email: Danny.Vesprini@sunnybrook.ca
• Phone: 416-480-6100

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Two-fraction radiotherapy for localized prostate cancer

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• Radiation therapy for recurrent prostate cancer

  This study is testing a new way to use radiation therapy for men with recurrent prostate cancer to see if it helps control the cancer better while also keeping their quality of life intact.

  Recruiting Phase 2 University of Miami · Miami, Florida · NCT06392295

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.