Clinical trial Recruiting at 4 sites Phase 2 Interventional Ages 50 and up Men only

Using PSMA PET scans to improve prostate cancer treatment accuracy

Official title: PSMA-Guided Ablation of the Prostate: A Multicenter Randomized Controlled Trial

Run by University of Alberta · NCT06003556 · Data updated 2026-11-12

This study is testing if a new type of PET scan can help men with localized prostate cancer get more accurate treatment before they undergo therapy.

Quick facts

PhasePhase 2
Study typeInterventional
Ages50 Years and up
SexMen only
Enrollment138 (estimated)
SponsorUniversity of Alberta
Academic / other
Drugs / interventionsradiation
Locations4 sites (Calgary, Alberta and 3 other locations)
StatusRecruiting
StartedApril 2, 2024
Main results expectedFebruary 26, 2029
Study endsFebruary 26, 2029
Registry record updatedJune 3, 2026
Trial IDNCT06003556 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men over 50 with unilateral Gleason Grade Group 2 or 3 prostate cancer and specific clinical staging criteria.

Probably not a fit

Patients with bilateral prostate cancer or those who have previously undergone androgen deprivation or radiation therapy will 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 phase 2 multicenter randomized controlled trial aims to evaluate the effectiveness of second generation PSMA PET imaging in accurately staging unilateral prostate cancer compared to standard MRI and biopsy methods. Eligible participants will be randomly assigned to receive either a PSMA PET scan or no further imaging before undergoing focal therapy. The study seeks to determine if PSMA PET can enhance diagnostic precision, thereby reducing the risk of residual or recurrent disease after treatment. The focus is on men diagnosed with localized prostate carcinoma who are candidates for focal therapy.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate treatment of prostate cancer, minimizing side effects and improving patient outcomes.

How similar studies have gone: Other studies have shown promise in using advanced imaging techniques for prostate cancer diagnosis, suggesting potential success for this novel approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Age \> 50
2. Clinical stage \< T2b
3. PSA \< 15
4. Combined targeted and systematic MRI-guided biopsy shows unilateral Gleason Grade Group 2 or 3 prostate cancer

Exclusion Criteria:

1. Unable to obtain consent
2. Weight \>250 kg (weight limitation of scanners)
3. Unable to lie flat for 30 minutes to complete the PET imaging
4. Lack of intravenous access
5. eGFR \< 40 mL/min/1.73 m2 and/or a history of a severe reaction to CT contrast
6. Prior androgen deprivation therapy or radiation therapy to prostate gland

Where it's running

  • Prostate Cancer Centre
    Calgary, Alberta, Canada
    Recruiting
  • Royal Alexandra Hospital
    Edmonton, Alberta, Canada
    Recruiting
  • University of Alberta Hospital
    Edmonton, Alberta, Canada
    Recruiting
  • Princess Margaret Cancer Centre
    Toronto, Ontario, Canada
    Recruiting

Study contacts

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.
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.