Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Prostatic Neoplasms
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
This open label, phase I/II non-randomised clinical trial will evaluate the dosimetry, efficacy and toxicity of Lu-PSMA in men with high PSMA-expressing high-risk localized or locoregional advanced prostate cancer (HRCaP) undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND)....
This open label, phase I/II non-randomised clinical trial will evaluate the dosimetry, efficacy and toxicity of Lu-PSMA in men with high PSMA-expressing high-risk localized or locoregional advanced prostate cancer (HRCaP) undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND). Patients will receive one or two cycles of 177Lu-PSMA followed by surgery. The primary objective is to determine the radiation absorbed dose in the prostate and involved lymph nodes. Secondary objectives include evaluating imaging response to therapy using PSMA-PET, biochemical response, pathological response, adverse effects of Lu-PSMA and surgical safety, and health-related Quality of Life (QoL).
Tracking Information
- NCT #
- NCT04430192
- Collaborators
- Movember Foundation
- Medical Research Future Fund (MRFF)
- Endocyte
- E.J. Whitten Foundation Prostate Cancer Research Centre
- Investigators
- Principal Investigator: Declan Murphy Peter MacCallum Cancer Centre, Australia Principal Investigator: Michael S Hofman Peter MacCallum Cancer Centre, Australia Principal Investigator: John Violet Peter MacCallum Cancer Centre, Australia
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