A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy

Phase 1

Not yet recruiting

• Conditions: Cancer; Prostate Cancer; Metastatic Cancer; Metastatic Prostate Cancer

• Registration Number: NCT05896371
• Lead Sponsor: CHU de Quebec-Universite Laval

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-5-31
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Inclusion Criteria:<br><br> - >18 y.o. adults able to provide consent<br><br> - Inoperable or metastatic PSMA-expressing cancer, with significant PSMA expression<br> defined as uptake in at least one lesion that is superior to that of the liver on<br> PSMA positron-emission tomography (PET) within 3 months prior to enrolment<br><br> - Cancer progression documented within 3 months prior to enrolment as per the<br> investigator's assessment, without initiation of another anti-cancer treatment since<br> (excluding palliative radiation therapy to a minority of the tumor burden), unless<br> that anti-cancer treatment was stopped prematurely because of intolerance<br><br> - For participants with a cancer other than mCRPC, a recommendation from a<br> multidisciplinary tumor board (MDT) in favor of PSMA RPT must be obtained<br><br>Exclusion Criteria:<br><br> - Platelets < 50 x 106/L<br><br> - Absolute neutrophil count (ANC) < 1.0 x 106/L<br><br> - Eastern Cooperative Oncology Group (ECOG) 4 or prognosis < 3 months, for<br> cancer-related or other serious medical conditions, as per investigator's assessment<br><br> - Known presence of central nervous system metastasis at risk of complication, which<br> cannot be adequately stabilized (e.g. radiotherapy or corticoid prophylaxis), as per<br> investigator's assessment<br><br> - Any condition that would limit the ability to comply with the study protocol, as per<br> investigator's assessment<br><br> - Pregnancy or breastfeeding (e.g. for female participants with non-prostate cancer)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase 1: Number of dose-limiting toxicities (DLTs);Phase 2: Overall response rate (ORR);Phase 2: Biochemical response rate (PSA50)

Secondary Outcome Measures

Name	Time	Method
Frequency and grades of treatment-related adverse events (AEs);Delayed AEs of particular interest;Phase 1: Overall response rate (ORR);Phase 1: Biochemical response rate (PSA50);Quality of life patient-reported outcome measures (PROMs) response rates;Progression-free survival (PFS);Overall survival (OS)