Clinical trial · Interventional
Radioligand fOr locAl raDiorecurrent proStaTe cancER
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 177Lu-PNT2002 | Drug | — | UNRESOLVED |
| High Dose Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- High Dose Radiation (HDR) arm
- description
- 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).
- interventionNames
- Radiation: High Dose Radiation
- type
- EXPERIMENTAL
- label
- Lutetium Arm
- description
- Patients in Lutetium Arm will receive 1 cycle of 177Lu-PSMA radioligand therapy plus 1 fraction of HDR brachytherapy.
- interventionNames
- Drug: 177Lu-PNT2002
- Radiation: High Dose Radiation
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMendez LC, Dhar A, Laidley D, Moussa M, Gomez JA, Chin J, Lee TY, Thiessen JD, Hoover D, Surrey K, Helou J, Velker V, Correa RJ, D'Souza D, Bayani J, Bauman G. The use of Lutetium-177 PSMA radioligand therapy with high dose rate brachytherapy for locally recurrent prostate cancer after previous definitive radiation therapy: a randomized, single-institution, phase I/II study (ROADSTER). BMC Cancer. 2023 Apr 20;23(1):362. doi: 10.1186/s12885-023-10851-0. PMID 37081426