Clinical Trial Title
An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With SoC, Versus SoC Alone, in Adult Male Patients With mHSPC (PSMAddition)National Clinical Trial Number:
NCT04720157Contact Information
Clinical Trial Protocol Description:
The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with mHSPC. In this study, the SoC is defined as a combination of Androgen Receptor Directed Therapy + Androgen Deprivation Therapy. Approximately 1126 patients will be randomized in this study.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are an adults ≥18 years of age.
- Have an ECOG performance status of 0 to 2.
- Have a life expectancy >9 months as determined by the study investigator.
- Have metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma (current or prior biopsy of the prostate and/or metastatic site).
- Have evidence of PSMA-positive disease as seen on a 68Ga-PSMA-11 PET/CT scan, and eligible as determined by the sponsor's central reader.
- Have at least one documented metastatic bone and/or soft tissue/visceral lesion documented.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.
Study Details
Clinical Trial Investigator
Alan Tan, MD
Contact Information
Rush Cancer Center Clinical Trials Office
Clinical Trial Location
RUSH University Medical Center