A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxan… (NCT05658003) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer
China63 participantsStarted 2023-05-05
Plain-language summary
The purpose of this study is to evaluate the efficacy of \[177Lu\]Lu-PSMA-617 over a change of androgen receptor-directed therapy (ARDT) treatment in prolonging radiographic progression free survival (rPFS) in Chinese metastatic castration-resistant prostate cancer patients, who were previously treated with another ARDT as last treatment and who have not been exposed to a taxane-containing regimen in castrate resistant prostate cancer (CRPC) or hormone-sensitive prostate cancer (HSPC) settings and who are considered appropriate for delaying taxane-based chemotherapy. The primary endpoint of rPFS will be assessed via blinded independent centralized review of radiographic images provided by the treating physician and as outlined in Prostate Cancer Working Group 3 (PCWG3) guidelines.
Who can participate
Age range18 Years – 100 Years
SexMALE
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Inclusion criteria
✓. Participants must be Chinese adult men \>= 18 years of age
✓. Participants must have an ECOG performance status of 0 to 1
✓. Participant must have histological pathological and/or cytological confirmation of adenocarcinoma of the prostate
✓. Participants must be \[68Ga\]Ga-PSMA-11 PET/CT scan positive, and eligible as determined by the sponsor's central reader
✓. Participants must have a castrate level of serum/plasma testosterone (\< 50 ng/dl, or \< 1.7 nmol/L)
✓. Participants must have progressed only once on prior second generation ARDT (abiraterone, enzalutamide, darolutamide, or apalutamide)) in either HSPC or CRPC setting.
✓. candidates for change in ARDT (eligible to receive abiraterone or enzalutamide) as assessed by the treating physician
✓. Documented progressive mCRPC, based on at least 1 of the following criteria:
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 47 months (estimated final analysis)
. Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, Lutitium-177, Actium-225, hemi-body irradiation
✕. Previous PSMA-targeted radioligand therapy
✕. Prior treatment with PARP inhibitor, cytotoxic chemotherapy for castration resistant or castration sensitive prostate cancer (i.e., taxanes, platinum, estramustine, vincristine, methotrexate, etc.), immunotherapy or biological therapy (including monoclonal antibodies). \[Note: a maximum of 6 cycles of taxane exposure in the adjuvant or neo-adjuvant setting is allowed if 12 months have elapsed since completion of this adjuvant or neo-adjuvant therapy prior to randomization\]
✕. Transfusion or use of bone marrow stimulating agents for the sole purpose of making a participant eligible for study inclusion
✕. Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
✕. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression
✕. Cardiac or cardiac repolarization abnormality, including any of the following: