First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer
A Phase IIA Study of Sequential ("First Strike, Second Strike") Therapies, Modeled on Evolutionary Dynamics of Anthropocene Extinctions, for High Risk Metastatic Castration Sensitive Prostate Cancer
Sponsor: H. Lee Moffitt Cancer Center and Research Institute + BeiGene
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Overall Survival
Time frame: Up to 36 months
Secondary Endpoints
PSA <0.2 nanogram per milliliter (ng/ml) rate at 6 months
PSA <0.2 nanogram per milliliter (ng/ml) rate at 12 months
PSA <0.2 nanogram per milliliter (ng/ml) rate at 36 months
Eligibility Criteria
Inclusion Criteria: * Biopsy proven prostate cancer and the diagnosis can be established through either prostate biopsy or biopsy of a metastatic lesion. High risk mCSPC is defined as having 2 of the 3 risk factors: a Gleason score of 8 or more, at least 3 bone metastases, and the presence of measurable visceral metastasis. * ECOG performance status of 0-1 * No androgen deprivation therapy (ADT) with LHRH analogue monotherapy for more than 12 weeks after the diagnosis of metastatic prostate cancer. Prior ADT in the non-metastatic setting is allowed if it was given \> 2 years prior to the diagnosis of metastatic prostate cancer and a reduction of PSA is documented after initiating ADT in the metastatic setting. * Agreeable to prostate biopsy after completing "second strike". * Adequate organ function with absolute neutrophil count \> 1000/l, Hb \> 10 g/dl, Platelet \> 100,000/l, Creatinine and liver enzymes within 1.5 folds of upper limits of normal * No uncontrolled arrhythmia; partic…
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