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| Name | Class |
|---|---|
| BeiGene | INDUSTRY |
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The goal of this clinical research is to find if sequential therapy with combined androgen deprivation or hormonal therapy with luteinizing hormone release hormone (LHRH) analog plus a new hormonal agent (abiraterone, enzalutamide, or apalutamide) followed by chemohormonal therapy with docetaxel and LHRH analog would improve the outcome of high risk metastatic/stage IV prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Strike then Second Strike | Experimental | The first part of the study treatment or "first strike" involves 12-18 weeks of combined therapy with LHRH analog and one of the new hormonal agents (NHAs). Participants will complete the "first strike" at week 13 if their PSA has reduced >90%; otherwise they will complete a total of 18 weeks of therapy. The second part of the treatment or "second strike" involves 4 cycles docetaxel and LHRH analog. The "second strike" will start immediately after the "first strike". MRI guided prostate biopsy will be performed after "second strike". For patients with positive prostate biopsy or detectable PSA, the "second strike" will be consolidated with 4-6 additional cycles of docetaxel plus 6 doses of tislelizumab at 200 mg, given IV once every 3 weeks. For patients with undetectable PSA at year 3 from study enrollment, LHRH analog can be discontinued. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luteinizing Hormone Releasing Hormone | Drug | During the first strike, LHRH will be administered for 12 to 18 weeks. During the second strike, participants will receive 4 cycles of LHRH |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival will be from initiation of first strike until failure or death from any cause. | Up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| PSA <0.2 nanogram per milliliter (ng/ml) rate at 6 months | Investigators will measure the PSA <0.2 nanogram per milliliter (ng/ml) at 6 months from the initiation of the first strike | At 6 months |
| PSA <0.2 nanogram per milliliter (ng/ml) rate at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Standard Uptake Values (SUV) | Investigators will track the changes on F18 (Posluma or Pylarify) PSMA PET scan after first and second strikes compared to baseline. | Up to 9 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jingsong Zhang, MD, PhD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trial Web Search | View source |
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| New Hormonal Agent | Drug | During the first strike, if Abiraterone is chosen 1000mg of Abiraterone will be taken orally. If Enzalutamide is used, 160 mg will be taken orally every 24 hours. |
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| Docetaxel | Drug | During the second strike, participants will receive 4 cycles of Docetaxel at 75mg/m2 given intravenously at day 1 of ever 21 days. For participants with positive prostate biopsy or detectable PSA, the "second strike" will receive 2 additional cycles of docetaxel. |
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| Tislelizumab | Drug | During the second strike, participants will receive 6 doses of Tislelizumab at 200 mg, given intravenously once every 3 weeks. |
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Investigators will measure the PSA <0.2 nanogram per milliliter (ng/ml) at 12 months from the initiation of the first strike |
| At 12 months |
| PSA <0.2 nanogram per milliliter (ng/ml) rate at 36 months | Investigators will measure the PSA <0.2 nanogram per milliliter (ng/ml) at 36 months from the initiation of the first strike | At 36 months |
| PSA Progression | Time to PSA progression from the initiation of "first strike" | Up to 36 months |
| Radiographic Progression | Investigators will measure the radiographic progression free survival rate at 36 months from the initiation of "first strike" | At 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 |
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| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D016729 | Leuprolide |
| D017329 | Triptorelin Pamoate |
| C561634 | relugolix |
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
| C089740 | abiraterone |
| C540278 | enzalutamide |
| D000077143 | Docetaxel |
| C000707970 | tislelizumab |
| 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 |
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