Status:
COMPLETED
Radioligand fOr locAl raDiorecurrent proStaTe cancER
Lead Sponsor:
Glenn Bauman
Collaborating Sponsors:
London Health Sciences Foundation
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Approximately 50-60% of men undergoing salvage brachytherapy post cancer recurrence to the prostate have the disease controlled at 5 years. This study aims to integrate a local treatment to the prosta...
Detailed Description
Surgery or radiation are common treatments for a prostate cancer that is confined to the prostate gland itself. After radiation treatment, a significant minority of patients (about one third) progress...
Eligibility Criteria
Inclusion
- Men with prostate adenocarcinoma treated with prior primary radiotherapy at least 2 years previously
- Biochemical failure according to the Phoenix criteria(Roach et al. 2006)
- PSMA PET demonstrating isolated uptake (SUV\>3) within the prostate
- Biopsy confirmation of local recurrence within the prostate
- Not currently experiencing genitourinary (GU) or gastrointestinal (GI) Grade 3 or higher toxicity associated with prior treatment
- Adequate marrow function (Absolute neutrophil count ≥ 1.5 x 109/L -Platelet count ≥ 100 x 109/L
- Hemoglobin ≥ 90 g/L with no transfusions in the past 2 weeks)
- Adequate renal function: Estimated creatinine clearance ≥ 30 ml/min according to Cockroft Gault equation:
- (140 - age) x (weight in kg) / 72 x (serum creatinine)
- Adequate liver function: Total bilirubin \< 1.5 x upper limit of normal (ULN). Alanine aminotransferase (ALT) \< 3.5 x ULN
- No contraindication to treatment with \[177Lu-PSMA Agent\]
- No contraindication to MRI
- No contraindication to therapy with high dose rate brachytherapy under general anaesthetic
Exclusion
- Does not meet eligibility criteria
- Prior ablative radiotherapy to the prostate (prior HDR or LDR brachytherapy or SBRT/SABR to prostate)
- Documented extraprostatic or distant recurrence on PSMA PET
- Consent not obtained or declines randomization
- Declines HDR salvage or not fit for HDR salvage procedure
- Concurrent use of hormone therapy
Key Trial Info
Start Date :
March 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05230251
Start Date
March 17 2022
End Date
December 31 2024
Last Update
September 12 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
London Health Sciences Centre
London, Ontario, Canada, N6A5W9