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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
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).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
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