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An International Prospective Open-label, Randomized, Phase III Study comparing 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic hormone Sensitive Prostate Cancer (mHSPC)

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.

At the study visits, the following procedures should happen: • Your study eligibility will be determined • There will be a review of your current medications and medical history • You will undergo a physical examination that includes measuring your height, weight, taking your vital signs, checking your heart with an electrocardiogram, and determining your ECOG performance status (a measure of your daily functional activity) • You may undergo tumor biopsy if clinically feasible according to your doctor or may be asked for a previously collected sample. You will be asked for a previously collected tumor biopsy if clinically feasible by your doctor • Blood and urine will be taken to determine the function of your liver, kidneys, and bone marrow function. • Blood samples will also be collected to assess potential changes in biological molecules in the blood such as certain proteins and pieces of DNA shed from tumor cells • You will receive a variety of imaging procedures to determine the status of your cancer throughout the study. These will include CT and PET scans, bone scans and may include other scans like X-rays and MRI scans. • On repeat visits, your doctor will ask you about any changes in the way you feel

Monika Joshi
Kathleen Rizzo - at

18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Patients must have metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma (current or prior biopsy of the prostate and/or metastatic site)
Patients must have an ECOG performance status of 0 to 2
Patients must be adults >= 18 years of age
Patients must have evidence of PSMA-positive disease as seen on a 68Ga-PSMA-11 PET/CT scan

Exclusion Criteria:
Patients with rapidly progressing tumor that requires urgent exposure to taxane-based chemotherapy
Patients with CNS metastases that are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity
Patients with a history of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
Patients with symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression
Patients who received transfusion for the sole purpose of making a subject eligible for study inclusion
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Location Contacts
Hershey, PA ,