Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Testosterone cypionate · 1 trial · 1 indication
Time from the date of the randomization to the date of first documented radiological progression per RECIST 1.1 for soft tissue or PCWG3 for bone lesions, or clinical progression or death, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Arm A: Enzalutamide | EXPERIMENTAL | Patients randomized to Arm A will receive continuous therapy with standard dose Enzalutamide (160 mg oral daily). |
| Arm B: Sequential Testosterone and Enzalutamide | EXPERIMENTAL | Patients in Arm B will receive intramuscular injection with testosterone cypionate (T) at a dose of 400 mg every 28 days x 2 (i.e. cycle 1). On Day 1 of cycle 2, patients will stop testosterone and begin enzalutamide 160 mg po q day for 56 days. Each cycle is 56 days. On Day 1 of cycle 3, patient will not take enzalutamide and will again receive injection of testosterone. Patients will continue to alternate one cycle of testosterone (2 injections) with one cycle of 56 days of enzalutamide. |
| Arm C: Variable Sequential Testosterone and Enzalutamide | EXPERIMENTAL | Patients in Arm C will receive intramuscular injection with testosterone cypionate (T) at a dose of 400 mg every 28 days x 2 injections per cycle. Each cycle is 56 days. Patients with PSA progression will stop T injection and begin Enzalutamide. Patients on T with initial PSA decline will remain on high dose T for additional cycles of 2 injections until PSA progression occurs (≥25% increase in PSA from PSA nadir on current BAT cycle). These patients will then be started on Enzalutamide. Patients with PSA progression will stop Enzalutamide and will restart injections of T with 2 injections/cycle. Patients on enzalutamide with initial PSA decline after one 56-day cycle will continue on Enzalutamide until PSA progression occurs (≥25% increase in PSA from PSA nadir on current Enzalutamide cycle). These cycles of switching between T and Enza with onset of PSA progression will continue until clinical and/or radiographic progression occurs. |
| Name | Type | Description |
|---|---|---|
| Testosterone cypionate | DRUG | Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate. |
| Enzalutamide | DRUG | Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide. |
| Testosterone enanthate | DRUG | Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative. |
Inclusion Criteria: 1. ECOG Performance status ≤2. 2. Age ≥18 years. 3. Histologically-confirmed adenocarcinoma of the prostate. 4. Treated with continuous androgen ablative therapy (either surgical castration or LHRH agonist/antagonist). 5. Documented castrate level of serum testosterone (\<50 ng/...
Testosterone cypionate is being studied for the treatment of Castration Resistant Metastatic Prostate Cancer. It is currently in Phase 2 clinical development as an investigational therapy. The drug is being evaluated in a randomized, controlled trial to assess its effects in this patient population.
Testosterone cypionate is being developed by United Therapeutics Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol UTHR. The company is conducting a Phase 2 clinical trial to evaluate the drug for the treatment of Castration Resistant Metastatic Prostate Cancer.
Testosterone cypionate is currently in Phase 2 clinical development. It is an investigational drug being studied for Castration Resistant Metastatic Prostate Cancer. The drug has not yet been approved by regulatory authorities and is still undergoing clinical trials to determine its safety and efficacy.
Testosterone cypionate is being evaluated in a Phase 2 clinical trial with the identifier NCT04363164. This trial, titled 'Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression', is currently recruiting participants in the United States. The study is randomized and controlled, with an estimated enrollment of 150 male patients aged 18 years and older.
Testosterone cypionate is a form of testosterone, specifically a prodrug of testosterone that is administered via injection. In the context of this clinical trial, it is being studied as a potential treatment for Castration Resistant Metastatic Prostate Cancer, where it may be used in a sequential regimen with enzalutamide.