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NCT04947254 · ClinicalTrials.gov registry record · Phase 2
Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer
A Phase 2 study of Prostate Carcinoma and Stage III Prostate Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT04947254 is a Phase 2 study of Prostate Carcinoma and Stage III Prostate Cancer AJCC v8 that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 200 participants, below the 1,498-participant average among 59 other Prostate Carcinoma trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04947254, a Phase 2 study of Prostate Carcinoma and Stage III Prostate Cancer AJCC v8, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the effect of androgen ablation therapy with or without niraparib after standard of care radiation therapy in treating patients with prostate cancer that has not spread to other parts of the body (localized) or that has spread to nearby tissue or lymph nodes (locally advanced). Androgen ablation therapy (also known as hormone therapy) lowers the levels of male hormones called androgens in the body. Androgens stimulate prostate cancer cells to grow. There are 2 types of androgen ablation therapy given in this study: AAP + ADT and Apa + ADT. AAP + ADT is the treatment combination of the drugs abiraterone acetate and prednisone (AAP) given with androgen deprivation therapy (ADT, also known as androgen deprivation therapy or androgen suppression medication, which is used as standard of care to lower testosterone levels in men with high risk localized or metastatic prostate cancer). Apa + ADT is the treatment combination of the drug apalutamide (Apa) given with ADT. Androgen ablation therapy with or without niraparib after radiation therapy may help to control the disease in patients with prostate cancer.
Conditions Studied
Interventions
- PROCEDURE Biopsy
- DRUG Apalutamide
- DRUG Antiandrogen Therapy
- DRUG Abiraterone Acetate
- DRUG Niraparib
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2021-08-05 |
| Est. Completion | 2026-06-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04947254
The ClinicalTrials.gov registry entry for NCT04947254 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,498-participant average among 59 other Prostate Carcinoma trials with a reported enrollment target (87% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Prostate Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biopsy is the first listed.
NCT04947254 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT04947254 about?
NCT04947254 is a clinical study titled "Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer". This phase II trial studies the effect of androgen ablation therapy with or without niraparib after standard of care radiation therapy in treating patients with prostate cancer that has not spread to other parts of the body (localized) or that has spread to nearby tissue or lymph nodes (locally adva...
What is the current status of trial NCT04947254?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2021-08-05. Estimated completion is 2026-06-07.
What conditions does trial NCT04947254 study?
This clinical trial studies the following conditions: Prostate Carcinoma, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8.
What interventions are being tested in trial NCT04947254?
The interventions under investigation include: Biopsy (PROCEDURE), Apalutamide (DRUG), Antiandrogen Therapy (DRUG), Abiraterone Acetate (DRUG), Niraparib (DRUG).
Who is sponsoring clinical trial NCT04947254?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04947254 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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