First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer (NCT05189457) | Clinical Trial Compass
Active — Not RecruitingPhase 2
First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer
United States32 participantsStarted 2022-01-25
Plain-language summary
The goal of this clinical research is to find if sequential therapy with combined androgen deprivation or hormonal therapy with luteinizing hormone release hormone (LHRH) analog plus a new hormonal agent (abiraterone, enzalutamide, or apalutamide) followed by chemohormonal therapy with docetaxel and LHRH analog would improve the outcome of high risk metastatic/stage IV prostate cancer.
Who can participate
Age range18 Years
SexMALE
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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; participants with h/o myocardial infarction or history of congestive heart failure, need to have estimated left ventricle ejection fraction above 40% either on echocardiogram or MUGA scan within 6 months of study enrollment.
* All men who are sexually active with a female partner of childbearing potential treated or enrolled on this protocol must agree to use highly effective barrier contraception prior to the study, for the duration of study participation, and for 7 months after last dose of tisleliz…
What they're measuring
1
Overall Survival
Timeframe: Up to 36 months
Trial details
NCT IDNCT05189457
SponsorH. Lee Moffitt Cancer Center and Research Institute