Radioligand fOr locAl raDiorecurrent proStaTe cancER (ROADSTER)
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility 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
Sites / Locations
- London Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
High Dose Radiation (HDR) arm
Lutetium Arm
Patients in the HDR arm will receive two fractions of HDR brachytherapy. HDR brachytherapy will be administered as per local practice and as previously described. All procedures will be conducted under general anesthesia in a dedicated brachytherapy suite using transrectal three dimensional ultrasound for image guidance. For all HDR fractions at least 10Gy will be delivered to the entire prostate with a boost to 13.5Gy to the involved prostate as determined by biopsy and PSMA PET/MRI results. In instances of multi-focal/diffuse involvement of the prostate, the entire prostate will receive 13.5Gy/fraction (respecting OAR constraints).
Patients in Lutetium Arm will receive 1 cycle of 177Lu-PSMA radioligand therapy plus 1 fraction of HDR brachytherapy.