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Spots Global Cancer Trial Database for Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy

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Trial Identification

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

Official Title: Study of the Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Radionuclide Therapy Prior to Radical Prostatectomy in Men With High-risk Localised Prostate Cancer

Study ID: NCT04430192

Interventions

177Lu-PSMA-617

Study Description

Brief 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)

Detailed 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). 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).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Contact Details

Name: Declan Murphy

Affiliation: Peter MacCallum Cancer Centre, Australia

Role: PRINCIPAL_INVESTIGATOR

Name: Michael S Hofman

Affiliation: Peter MacCallum Cancer Centre, Australia

Role: PRINCIPAL_INVESTIGATOR

Name: John Violet

Affiliation: Peter MacCallum Cancer Centre, Australia

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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