Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adaptive Androgen Deprivation and Docetaxel Treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luteinizing Hormone-Releasing Hormone (LHRH) analog | Drug | The choice of the standard of care LHRH analog will be at the discretion of the treating physician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Castration Sensitivity Rate | Percentage of patients who remain castration sensitive at 36 months from initiation of LHRH analog for stage IV prostate cancer. | Up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| On treatment PSA Progression Free Survival | On treatment PSA progression free survival will be analyzed using the Kaplan-Meier method. | Up to 36 months |
| Radiographic Progression Free Survival | Radiographic progression free survival will be analyzed using the Kaplan-Meier method. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jingsong Zhang, MD, PhD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Caner Center | Tampa | Florida | 33612 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Androgen Receptor Signal Inhibitor (ARSI) | Drug | The choice of the standard of care ARSI will be at the discretion of the treating physician. |
|
|
| Docetaxel | Drug | Docetaxel will be given by IV infusion at 75mg/m2 once every 3 weeks. |
|
| Up to 36 months |
| Overall Survival | Overall survival will be analyzed using the Kaplan-Meier method. | 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). | Up to 36 months |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
| D016729 | Leuprolide |
| D017329 | Triptorelin Pamoate |
| C561634 | relugolix |
| C540278 | enzalutamide |
| C572045 | apalutamide |
| C000607739 | darolutamide |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided