An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in … (NCT04720157) | Clinical Trial Compass
Active — Not RecruitingPhase 3
An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
United States1,145 participantsStarted 2021-06-09
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care (SOC), versus Standard of Care alone, in adult male patients with Metastatic hormone sensitive prostate cancer (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. As of 31-Jan-2024, 1144 participants were enrolled in 20 countries.
Who can participate
Age range18 Years – 100 Years
SexMALE
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Inclusion criteria
✓. Signed informed consent must be obtained prior to participation in the study
✓. Patients must be adults ≥18 years of age
✓. Patients must have an ECOG performance status of 0 to 2
✓. Patients must have a life expectancy \>9 months as determined by the study investigator
✓. 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 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
✓. Patients must have at least one documented metastatic bone and/or soft tissue/visceral lesion documented in the following manners within 28 days prior randomization:
✓. Metastatic disease to the bone (in any distribution) visible on 99Tc-MDP bone scintigraphy on either pre-ADT scans or baseline scans AND/OR
Exclusion criteria
What they're measuring
1
Radiographic Progression Free Survival (rPFS)
Timeframe: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 50 months (estimated final OS analysis)
✕. Participants with rapidly progressing tumor that requires urgent exposure to taxane-based chemotherapy
✕. Any prior systemic anti-prostate cancer therapy (with the exception of the drugs listed on inclusion criteria 11), including chemotherapy, Poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors, immunotherapy or biological therapy (including monoclonal antibodies).
✕. Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed
✕. Ongoing participation in any other clinical trial
✕. Use of other investigational drugs within 30 days prior to day of randomization
✕. Known hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes
✕. Transfusion for the sole purpose of making a participant eligible for study inclusion