A Phase 2 interventional study of Luteinizing Hormone-Releasing Hormone (LHRH) analog and Androgen Receptor Signal Inhibitor (ARSI) in Metastatic Castration Sensitive Prostate Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Active, not recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 2, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 25 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This study will consist of various visits: a screening visit, 1-3 visits during the screening standard of care treatment period and visits every 4 weeks during the adaptive therapy period.
Drug: Luteinizing Hormone-Releasing Hormone (LHRH) analog · Drug: Androgen Receptor Signal Inhibitor (ARSI) · Drug: Docetaxel
The choice of the standard of care LHRH analog will be at the discretion of the treating physician.
Also known as: Degarelix, Leuprolide, Triptorelin, Relugolix
The choice of the standard of care ARSI will be at the discretion of the treating physician.
Also known as: Enzalutamide, Apalutamide, Darolutamide
Docetaxel will be given by IV infusion at 75mg/m2 once every 3 weeks.
Castration Sensitivity Rate
Percentage of patients who remain castration sensitive at 36 months from initiation of LHRH analog for stage IV prostate cancer.
Time frame: Up to 36 months
On treatment PSA Progression Free Survival
On treatment PSA progression free survival will be analyzed using the Kaplan-Meier method.
Time frame: Up to 36 months
Radiographic Progression Free Survival
Radiographic progression free survival will be analyzed using the Kaplan-Meier method.
Time frame: Up to 36 months
Overall Survival
Overall survival will be analyzed using the Kaplan-Meier method.
Time frame: Up to 36 months
Patient Reported Outcome
Patient reported outcome as measured by National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Prostate Cancer Symptom Index -17 items (NFPSI-17).
Time frame: Up to 36 months
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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H. Lee Moffitt Cancer Center and Research Institute