Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (NCT06734130) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer
United States25 participantsStarted 2025-01-10
Plain-language summary
This is a prospective single center phase IIa open label nonrandomized study, which aims to test the hypothesis that the duration of castration sensitive phase of stage IV prostate cancer can be prolonged with adaptive androgen deprivation therapy (ADT) and Docetaxel.
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.
* No androgen deprivation therapy (ADT) with LHRH analog for more than 4 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.
* Achieved \>50% PSA decline and \<4 ng/ml PSA after the run-in period.
* 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; patients with h/o myocardia 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.
* ECOG performance status 0-1.
* Non-sterilized men who are sexually active with a female partner of childbearing potential treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 weeks after last dose of ARSI or docetaxel administration.
* Ability to understand and the willingness to sign a written informed consent document or have a legally authorized representative sign on the subject's behalf. Stated willingness to comply with all study procedures and availability for the duration…
What they're measuring
1
Castration Sensitivity Rate
Timeframe: Up to 36 months
Trial details
NCT IDNCT06734130
SponsorH. Lee Moffitt Cancer Center and Research Institute