Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT05230251
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05230251
Study Brief:
Protocol Section:
NCT05230251