Using PSMA PET scans to improve prostate cancer treatment accuracy
PSMA-Guided Ablation of the Prostate: A Multicenter Randomized Controlled Trial
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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | University of Alberta Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Calgary, Alberta and 2 other locations) |
| Trial ID | NCT06003556 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men over 50 with unilateral Gleason Grade Group 2 or 3 prostate cancer and specific clinical staging criteria.
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.
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 performed: Other studies have shown promise in using advanced imaging techniques for prostate cancer diagnosis, suggesting potential success for this novel approach.
Eligibility criteria
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 this trial is running
Calgary, Alberta and 2 other locations
- Prostate Cancer Centre — Calgary, Alberta, Canada (Recruiting)
- Royal Alexandra Hospital — Edmonton, Alberta, Canada (Recruiting)
- University of Alberta Hospital — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Study coordinator: Adam Kinnaird, MD, PhD
- Email: ask@ualberta.ca
- Phone: (780) 407-5800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.