Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Antiandrogen Therapy · 1 trial · 3 indications
The complete PSA response is defined as a PSA =\< 0.2 ng/ml, confirmed with a 2nd measurement at least 3 weeks later. The estimated PSA response rate will be computed with 95% exact confidence interval. Binomial exact test will be used to determine whether the complete PSA response rate is significantly greater than 43%.
| Arm | Type | Description |
|---|---|---|
| Treatment (apalutamide, abiraterone acetate, prednisone, ADT) | EXPERIMENTAL | Patients receive apalutamide PO QD, abiraterone acetate PO QD, and prednisone PO QD. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive androgen deprivation therapy per standard of care. Patients undergo CT scan, bone scan and blood sample collection throughout the study. |
| Name | Type | Description |
|---|---|---|
| Abiraterone Acetate | DRUG | Given PO |
| Antiandrogen Therapy | DRUG | Given ADT per standard of care |
| Apalutamide | DRUG | Given PO |
| Prednisone | DRUG | Given PO |
| Computed Tomography | PROCEDURE | Undergo CT scan |
| Bone Scan | PROCEDURE | Undergo bone scan |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Questionnaire Administration | OTHER | Ancillary studies |
Inclusion Criteria: * Patients must have histologically or cytologically confirmed prostate cancer OR a strong suspicion of prostate cancer as evidenced by metastatic disease in a pattern consistent with prostate cancer (such as blastic lesions on a nuclear medicine bone scan or lymphadenopathy on ...
Antiandrogen Therapy is used for Castration-Sensitive Prostate Carcinoma, specifically in patients with metastatic prostate carcinoma and Stage IVB prostate cancer. It is being studied as an advanced chemo-hormonal therapy for treatment-naive metastatic prostate cancer, according to clinical trial NCT04267887.
Antiandrogen Therapy is being developed by Johnson & Johnson, a company traded on the stock exchange under the ticker JNJ. The therapy is currently in Phase 2 clinical development for the treatment of Castration-Sensitive Prostate Carcinoma.
Antiandrogen Therapy is in Phase 2 clinical development. It is an investigational therapy, not yet approved by regulatory authorities, and is being studied in an active clinical trial for Castration-Sensitive Prostate Carcinoma.
Antiandrogen Therapy is being evaluated in clinical trial NCT04267887, titled 'Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer.' This Phase 2 trial is active but not recruiting, with an enrollment of 7 participants, and is being conducted in the United States.
Antiandrogen Therapy is a small molecule therapy being developed by Johnson & Johnson. It is being studied specifically for Castration-Sensitive Prostate Carcinoma in a Phase 2 trial. The therapy is biomarker-selected, meaning it is being tested in a patient population identified by specific biomarkers.