Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer

Launched by H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE · Dec 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment approach for men with metastatic castration-sensitive prostate cancer, which is a form of prostate cancer that has spread beyond the prostate but still responds to hormone therapy. The researchers want to see if combining a specific hormone therapy known as adaptive androgen deprivation therapy (ADT) with a chemotherapy drug called Docetaxel can help prolong the time that the cancer remains sensitive to these treatments.

To participate in this trial, men aged 65 to 74 with a confirmed diagnosis of prostate cancer are needed. They should not have received certain previous treatments for their cancer and must have shown a significant decrease in a blood marker called PSA after an initial treatment phase. Participants will undergo close monitoring during the trial, and they will need to agree to use birth control if they are sexually active, to avoid any risk of pregnancy. This study is currently recruiting, and it's an opportunity for eligible patients to help explore new treatment options that could improve care for future patients with similar cancer types.

Gender

MALE

Eligibility criteria

• 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 of the study.
• Exclusion Criteria:
• • Prior treatments with TAK-700/Orteronel, abiraterone, apalutamide or enzalutamide.
• • Surgical castration.
• • Documented liver or brain metastases
• • History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel (including any drugs formulated with polysorbate 80), or LHRH analog (e.g., leuprolide, triptorelin, relugolix, degarelix)
• • Treatment with any investigational compound within 30 days prior to the first dose of study drugs.
• • Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of LHRH analog, or previously diagnosed with another malignancy \& have any evidence of residual disease. Patients with early-stage skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
• • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• • Subjects with delayed healing of wounds, ulcers, and/or bone fractures.