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Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy

NCT04430192 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-11-08

No results posted yet for this study

Summary

This 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)

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

177Lu-PSMA-617

Patients 1-10 will be given 5GBq of 177Lu-PSMA. Patients 11-20 will be given 2 cycles of 5GBq of 177Lu-PSMA, separated by 6 weeks.

Sponsors & Collaborators

  • Movember Foundation

    collaborator OTHER

  • Medical Research Future Fund

    collaborator OTHER

  • Endocyte

    collaborator INDUSTRY

  • E.J. Whitten Foundation Prostate Cancer Research Centre

    collaborator UNKNOWN

  • Peter MacCallum Cancer Centre, Australia

    lead OTHER

Principal Investigators

  • Declan Murphy · Peter MacCallum Cancer Centre, Australia

  • Michael S Hofman · Peter MacCallum Cancer Centre, Australia

  • John Violet · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-06
Primary Completion
2022-12-22
Completion
2025-08-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04430192 on ClinicalTrials.gov