Registry of men treated with PSMA theranostics for prostate cancer
Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC) Prospective Patient Registry of Men Treated With PSMA Theranostics
This study is collecting information on men with advanced prostate cancer who are treated with a specific therapy to see how well it works and how it affects their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Peter MacCallum Cancer Centre, Australia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT04769817 on ClinicalTrials.gov |
What this trial studies
This registry collects data on men with metastatic castration-resistant prostate cancer (mCRPC) who are treated with Lutetium 177 (177Lu)-PSMA outside of clinical trials. It aims to assess the real-world effectiveness of 177Lu-PSMA by evaluating prostate specific antigen (PSA) response rates, safety, and overall survival. The study also examines health-related quality of life and pain, while identifying biomarkers linked to clinical outcomes. Data is captured electronically to facilitate comprehensive analysis.
Who should consider this trial
Good fit: Ideal candidates are men diagnosed with metastatic castration-resistant prostate cancer who have experienced progression or intolerance on novel anti-androgen therapies.
Not a fit: Patients who have not been treated with novel anti-androgen therapies or those who are not diagnosed with mCRPC may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the effectiveness and safety of PSMA theranostics, potentially improving treatment options for patients with mCRPC.
How similar studies have performed: Other studies have shown promise in using PSMA theranostics for prostate cancer treatment, indicating a growing body of evidence supporting this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Melbourne, Victoria
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Elizabeth Medhurst
- Email: ProsTIC@petermac.org
- Phone: +61 3 8559 8617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.