Radioligand fOr locAl raDiorecurrent proStaTe cancER

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: Male

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 prostate (brachytherapy) with a treatment involving 177Lutetium (Lu)- Prostate-Specific Membrane Antigen (PSMA) therapy. Differently than brachytherapy, 177-Lutetium-PSMA is thought to have its effect not only to the cancer cells within the prostate, but also to cancer cells located elsewhere in the body. Thus, the idea here is that by adding 177Lutetium (Lu)- PSMA early in the course of treatment we may be able to inactivate potential metastatic cells outside the prostate, while the prostate cancer within this organ still treated by the combination of brachytherapy and 177-Lutetium-PSMA.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glenn Bauman
• Collaborator: London Health Sciences Foundation

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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