Clinical trial · Observational
ProsTIC Registry of Men Treated With PSMA Theranostics
Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC) Prospective Patient Registry of Men Treated With PSMA Theranostics
NCT04769817CI-TRIAL-00111482active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a descriptive, observational, prospective, open-ended, registry utilising electronic data capture to collect information on the outcomes of men treated with prostate specific-membrane antigen (PSMA) theranostics.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 177Lu-PSMA | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- PSA-RR
- timeFrame
- From baseline through to progression or death until registry completion (approx. 5 years).
- description
- Prostate specific antigen-response rate (PSA-RR) defined as the proportion of participants with a PSA reduction of ≥ 50 percent from baseline.
Secondary outcomes (6)
- measure
- Number of participants with Adverse Events (AE) and Serious Adverse Events (SAE) measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
- timeFrame
- From date of treatment to 12 weeks after completing study treatment.
- description
- Safety of the combination will be measured by selected AEs and SAEs; only grade 3 or greater AEs related to 177Lu-PSMA with the exception of lymphopenia and fatigue or any grade 1-2 AEs that have not previously been reported with 177Lu-PSMA
- measure
- Radiographic progression-free survival (rPFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 1. Diagnosis of mCRPC 2. Progression or intolerance on a novel anti-androgen therapy (e.g. abiraterone, enzalutamide, apalutamide or darolutamide) 3. Prior therapy with at least one taxane cytotoxic (these agents may have been received upfront for metastatic hormone-sensitive prostate cancer) or the patient is symptomatic and assessed as unfit for chemotherapy 4. Referred to nuclear medicine and being considered for Lu-PSMA therapy according to institutional procedure guidelines
References
Publications (1)
- DERIVEDChen DC, Buteau JP, Papa N, Akhurst T, Alipour R, Bollampally N, Cardin A, Eifer M, Casanueva Eliceiry S, Jackson P, Jewell K, Kashyap R, Kong G, Kostos L, Ravi Kumar A, McIntosh L, Medhurst E, Saghebi J, Sandhu S, Murphy DG, Tran B, Azad AA, Hofman MS. Prognostic Value of Initial Imaging and PSA Change with [177Lu]Lu-PSMA-617 Radiopharmaceutical Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer: A ProsTIC Registry Analysis. J Nucl Med. 2025 Dec 3;66(12):1914-1920. doi: 10.2967/jnumed.125.270804. PMID 41067860