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Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up Men only

Focal dose escalation for localized prostate cancer treatment

Official title: A Phase II Study of the Use of MRI-defined Focal Boosts With Stereotactic Body Radiotherapy for Localized Prostate Cancer

Run by Ottawa Hospital Research Institute · NCT05851547 · Data updated 2026-11-12

This study is testing a new way to treat localized prostate cancer by giving higher doses of radiation in a shorter time while also using hormone therapy to see if it works better and causes fewer side effects.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment54 (estimated)
SponsorOttawa Hospital Research Institute
Academic / other
Locations1 site (Ottawa, Ontario)
StatusRecruiting
StartedNovember 23, 2023
Main results expectedJune 2027
Study endsJune 2028
Registry record updatedJanuary 5, 2024
Trial IDNCT05851547 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include men aged 18 and older with histologically confirmed adenocarcinoma of the prostate classified as unfavorable intermediate-risk or high-risk localized disease.

Probably not a fit

Patients with low-risk prostate cancer or those who do not meet the specific eligibility criteria may not benefit from this study.

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 a new approach to treating localized prostate cancer by using ultra-hypofractionated external beam radiotherapy combined with androgen deprivation therapy. The study aims to deliver radiotherapy in larger doses over a shorter period, guided by multiparametric magnetic resonance imaging to target tumor areas more effectively. By focusing the treatment on specific lesions within the prostate, the researchers hope to improve treatment efficacy while minimizing side effects compared to the standard uniform irradiation method. The trial will assess the safety and side effects of this innovative approach over a one-year follow-up period.

Why it matters

Potential benefit: If successful, this treatment could reduce the risk of cancer recurrence while maintaining a similar safety profile to current standard therapies.

How similar studies have gone: Previous studies have shown promise for ultra-hypofractionated approaches in treating localized prostate cancer, indicating potential for success in this trial.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Unfavourable intermediate-risk or high-risk localized disease
* Unfavourable intermediate-risk prostate cancer is defined as intermediate-risk prostate cancer \[that is, no high-risk features and one or more intermediate-risk factors: T2b-T2c, Gleason 3+4 (grade group 2) or Gleason 4+3 (grade group 3), or PSA 10-20 μg/L\] and one or more of the following: 2 or 3 intermediate-risk factors; Gleason 4+3 (grade group 3); ≥ 50% biopsy cores positive
* High-risk localized prostate cancer is defined as at least one of the following: T3a-T3b; Gleason ≥ 8 (grade group 4 or grade group 5); PSA \> 20 μg/L
* 3 Tesla prostate MRI done no more than 12 months prior to enrollment
* ECOG performance status 0-2
* Age ≥ 18 years
* Written informed consent
* The participant has planned androgen deprivation therapy that meets one of the following criteria:
* Patients with intermediate-risk localized prostate cancer who have planned androgen deprivation therapy consisting of up to 6 months of triptorelin with or without bicalutamide; OR patients with high-risk localized prostate cancer who have planned androgen deprivation therapy consisting of up to 24 months of triptorelin with or without bicalutamide.
* Completion of all appropriate investigations prior to enrollment

Exclusion Criteria:

* Evidence of pelvic nodal metastases or distant metastases (AJCC Stage T1-4 N1 M0-1 or T1-4 N0 M1 disease)
* Discordance between pre-enrollment prostate MRI and prostate biopsy findings, defined as biopsy cores with Gleason Gleason ≥ 4+3 (grade group ≥ 3) adenocarcinoma with no corresponding tumour focus seen on MRI
* Androgen deprivation therapy commenced more than 60 days prior to enrollment
* Intention to electively treat the pelvic lymph nodes with radiotherapy
* Other active malignancy within the previous three years (except adequately treated nonmelanomatous carcinoma of the skin or low-grade superficial bladder carcinoma)
* Prior pelvic radiotherapy
* Contraindication to pelvic radiotherapy
* Any history, past or present, of inflammatory bowel disease
* Unilateral or bilateral hip arthroplasty
* Trans-urethral resection of the prostate (TURP) performed within 6 months of anticipated start date of radiotherapy
* Patients must not concurrently participate in any other therapeutic prostate cancer trial.

Where it's running

  • The Ottawa Hospital Cancer Centre
    Ottawa, Ontario, Canada     Recruiting

Study contacts

  • Principal investigator: Scott C Morgan, MD, MSc — The Ottawa Hospital Cancer Centre
  • Study coordinator: Scott Grimes
  • Email: sgrimes@ohri.ca
  • Phone: 613-737-7700

Similar studies

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

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.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.