Status:
RECRUITING
PSMA-Guided Ablation of the Prostate
Lead Sponsor:
University of Alberta
Conditions:
Prostate Cancer
Localized Prostate Carcinoma
Eligibility:
MALE
50+ years
Phase:
PHASE2
Brief Summary
The goal of this phase 2 multicenter randomized controlled trial is to study the accuracy of second generation prostate specific membrane antigen (PSMA) positron emission tomography (PET; utilizing 18...
Detailed Description
1. Background \& Rationale Focal therapy is emerging as a new treatment strategy for appropriately selected men with localized prostate cancer. Focal therapy (also called partial gland ablation) i...
Eligibility Criteria
Inclusion
- Age \> 50
- Clinical stage \< T2b
- PSA \< 15
- Combined targeted and systematic MRI-guided biopsy shows unilateral Gleason Grade Group 2 or 3 prostate cancer
Exclusion
- Unable to obtain consent
- Weight \>250 kg (weight limitation of scanners)
- Unable to lie flat for 30 minutes to complete the PET imaging
- Lack of intravenous access
- eGFR \< 40 mL/min/1.73 m2 and/or a history of a severe reaction to CT contrast
- Prior androgen deprivation therapy or radiation therapy to prostate gland
Key Trial Info
Start Date :
April 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 26 2029
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT06003556
Start Date
April 2 2024
End Date
February 26 2029
Last Update
July 4 2025
Active Locations (3)
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1
Prostate Cancer Centre
Calgary, Alberta, Canada, T2V 1P9
2
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
3
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7