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Also known as Apalutamide 60mg Tab
Apalutamide Tab · 1 trial · 1 indication
Pathological Minimal Residual Disease (pMRD): pathological minimal residual disease (pMRD) is defined as residual tumour 5mm or less.
Pathological minimal residual disease is defined as residual tumour 5 mm or less.
| Arm | Type | Description |
|---|---|---|
| Group 1a | ACTIVE_COMPARATOR | LHRHa plus apalutamide. |
| Group 1b | ACTIVE_COMPARATOR | LHRHa plus apalutamide plus abiraterone acetate plus prednisone. |
| Group 2a | ACTIVE_COMPARATOR | LHRHa plus abiraterone acetate plus prednisone. |
| Group 2b | ACTIVE_COMPARATOR | LHRHa plus abiraterone acetate plus prednisone plus docetaxel. |
| Group 3 | ACTIVE_COMPARATOR | LHRHa plus abiraterone acetate plus prednisone plus niraparib |
| Group 4 | ACTIVE_COMPARATOR | LHRHa plus apalutamide plus atezolizumab |
| Group 5 | ACTIVE_COMPARATOR | LHRHa plus abiraterone acetate plus prednisone plus tazemetostat |
| Group 6 | ACTIVE_COMPARATOR | LHRHa plus abiraterone acetate plus prednisone plus Capivasertib |
| Name | Type | Description |
|---|---|---|
| Apalutamide 60mg Tab | DRUG | 4 tablets by mouth once a day for 24 weeks |
| Abiraterone Acetate 250mg | DRUG | 4 tablets by mouth on an empty stomach once a day for 16 weeks |
| Prednisone 5mg Tab | DRUG | 1 tablet by mouth once daily while taking abiraterone acetate |
| Docetaxel | DRUG | Infusion every 3 weeks for 6 cycles (each cycle has 3 weeks) |
| Niraparib 100mg Oral Capsule | DRUG | 3 capsules by mouth once daily for 16 weeks |
| Atezolizumab | DRUG | 1200mg infusion every 3 weeks for 6 cycles |
| Tazemetostat Pill | DRUG | 200 mg 4 tablets by mouth twice daily with or without food for 16 weeks |
| Capivasertib | DRUG | 200 mg 2 tablets by mouth twice a day with or without food on an intermittent dosing schedule (days 1-4, then 3 days off) each week for 16 weeks |
Inclusion Criteria: i. Males ≥ 18 years of age. ii. Histologically confirmed adenocarcinoma of the prostate without pathologic evidence of small cell differentiation at the time of initial diagnosis. Screening biopsy must be performed within 4 months of the screening visit. iii. High-risk localize...
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Apalutamide Tab is an investigational small molecule being studied for the treatment of prostate cancer. It is currently in Phase 2 clinical development for this indication. The drug is being evaluated in a genomic biomarker-selected umbrella neoadjuvant study for high risk localized prostate cancer.
Apalutamide Tab is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 2 clinical development for prostate cancer.
Apalutamide Tab is in Phase 2 clinical development. It is an investigational drug being studied for prostate cancer and has not been approved by regulatory authorities. The drug is currently being evaluated in an active clinical trial.
Apalutamide Tab is being studied in clinical trial NCT04812366, titled "Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer." This Phase 2 trial is recruiting participants in the United States and Canada, with an enrollment of 315 male patients aged 18 years and older.
Yes, Apalutamide Tab is also known as Apalutamide 60mg Tab. Both names refer to the same drug, which is being developed by Johnson & Johnson for the treatment of prostate cancer.
The clinical trial for Apalutamide Tab, NCT04812366, is a randomized, active-controlled Phase 2 study. It is biomarker-selected and does not use a double-blind design. The trial is currently recruiting and is being conducted in the United States and Canada.