Prolonging treatment effectiveness in advanced prostate cancer
A Phase IIA Study of Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer
This study is testing if a new way of combining hormone therapy and chemotherapy can help men with advanced prostate cancer stay in a better state for longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute Academic / other |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT06734130 on ClinicalTrials.gov |
What this trial studies
This phase IIa open-label study investigates the potential to extend the duration of the castration-sensitive phase in patients with stage IV metastatic prostate cancer using adaptive androgen deprivation therapy (ADT) combined with Docetaxel. The study will enroll patients who have not undergone more than four weeks of prior ADT and have shown a significant decline in PSA levels after a run-in period. The approach aims to optimize treatment outcomes by tailoring therapy based on individual patient responses.
Who should consider this trial
Good fit: Ideal candidates include men with biopsy-proven metastatic prostate cancer who have not received prolonged androgen deprivation therapy and have achieved a significant decline in PSA levels.
Not a fit: Patients who have undergone extensive prior androgen deprivation therapy or have uncontrolled cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment duration and outcomes for patients with metastatic castration-sensitive prostate cancer.
How similar studies have performed: Other studies have shown promise in using adaptive therapy approaches in cancer treatment, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tampa, Florida
- Moffitt Caner Center — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Jingsong Zhang, MD, PhD — Moffitt Cancer Center
- Study coordinator: Sara Donadelli
- Email: Sara.Donadelli@moffitt.org
- Phone: 813-745-8111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.