NCT05230251CompletedPhase 1/2
Radioligand fOr locAl raDiorecurrent proStaTe cancER
Source: ClinicalTrials.gov · Last updated 12 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 3 (actual)
- First submitted
- 19 Jan 2022
- Start date
- 17 Mar 2022
- Primary completion date
- 25 Sept 2023
- Lead sponsor
- Glenn Bauman
- Diseases
- Prostate cancer
- NCT number
- NCT05230251
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 3
- From 17 Mar 2022 to the primary completion date, 25 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior ablative radiotherapy to the prostate (prior HDR or LDR brachytherapy or SBRT/SABR to prostate)
- Concurrent use of hormone therapy
Other
- Does not meet eligibility criteria
- Documented extraprostatic or distant recurrence on PSMA PET
- Consent not obtained or declines randomization
- Declines HDR salvage or not fit for HDR salvage procedure
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.