ProsTIC Registry of Men Treated With PSMA Theranostics

NCT04769817 | Recruiting DMC FDA Drug

• 1 other identifier: PMC 20/164
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer; Metastatic Castration-resistant Prostate Cancer

Keywords

Prostate Cancer; Metastatic Castration-resistant Prostate Cancer; Theranostic; 177Lu-PSMA; Radionuclide Therapy

Outcome Measures

Primary Outcomes (1)

• PSA-RR

  Prostate specific antigen-response rate (PSA-RR) defined as the proportion of participants with a PSA reduction of ≥ 50 percent from baseline.

  From baseline through to progression or death until registry completion (approx. 5 years).

Secondary Outcomes (6)

• 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

  From date of treatment to 12 weeks after completing study treatment.

• Radiographic progression-free survival (rPFS)

  From date of treatment through to progression or death until registry completion (approx. 5 years).

• PSA progression free survival (PSA-PFS)

  From date of treatment through to progression or death until registry completion (approx. 5 years).

• Overall survival (OS)

  From date of treatment, up until 18 months after the last patient commences treatment.

• EORTC QLQ-C30

  From baseline through to progression or death until registry completion (approx. 5 years).

Other Outcomes (6)

• Prognostic and predictive value of baseline PET/CT

  Baseline PSMA and FDG PET/CT within 3 months of 177Lu-PSMA therapy.

• Prognostic value of 12 week restaging PSMA and FDG PET/CT

  12 weeks after first cycle of 177Lu-PSMA therapy.

• Histopathology parameters

  At baseline, 12 weeks post treatment and date of progression.

Interventions

177Lu-PSMA OTHER

Lu-PSMA will be administered as a standard-of-care procedure following assessment of suitability by a nuclear medicine physician and managed in close collaboration with the patient's medical oncologist.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Men with metastatic castration-resistant prostate cancer (mCRPC).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men with mCRPC who have progressed after novel anti-androgen therapy and taxane chemotherapy (unless unfit and symptomatic).

You may qualify if:

• Diagnosis of mCRPC
• Progression or intolerance on a novel anti-androgen therapy (e.g. abiraterone, enzalutamide, apalutamide or darolutamide)
• 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
• Referred to nuclear medicine and being considered for Lu-PSMA therapy according to institutional procedure guidelines

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia: lead

Study Sites (1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Prognostic and predictive biomarkers associated with treatment outcome and response will be assessed. This will include any of the following: i. Circulating tumour deoxyribonucleic acid (DNA) ± tumour tissue (DNA repair genes, tumour suppressor genes, androgen receptor); and ii. Whole blood ribonucleic acid (RNA) (androgen receptor splice variants, TMPRSS2:ERG fusion) iii. Blood or histopathology parameters

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Elizabeth Medhurst

CONTACT

+61 3 8559 8617; ProsTIC@petermac.org

Gaurav Sharma

CONTACT

03 85596830; Gaurav.Sharma@petermac.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: February 25, 2021
• Study Start: May 1, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)