Last reviewed · How we verify
NCT04056754
Study of Abiraterone Acetate in Subjects With Metastatic Castration Resistant Prostate Cancer
Phase 3 trial testing Abiraterone Acetate in Metastatic Castration Resistant Prostate Cancer in 268 participants. Completed in 16 July 2019.
14 March 2018
Quick facts
| Lead sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 268 |
| Start date | 16 July 2014 |
| Primary completion | 14 March 2018 |
| Estimated completion | 16 July 2019 |
| Sites | 16 locations across China |
Drugs / interventions tested
- Abiraterone Acetate (ABIRATERONE) — full drug profile →
- Placebo
- Prednisone (prednisone) — full drug profile →
Conditions studied
- Metastatic Castration Resistant Prostate Cancer — all drugs for Metastatic Castration Resistant Prostate Cancer →
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. — full company profile →
Who can join
18 and older, male only, with Metastatic Castration Resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Abiraterone acetate is an orally effective CYP17 inhibitor, which is metabolized into abiraterone in the body, and its inhibitory activity against CYP17 is 10-30 times that of ketoconazole. Clinical studies have shown that abiraterone acetate can significantly reduce the level of prostate specific antigen (PSA) in PCa patients, and help to reduce tumors, extending the lifespan of patients with advanced PCa for several years, and the toxicity is acceptable.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Targeting signaling pathways in prostate cancer: mechanisms and clinical trials.
He Y, Xu W, Xiao YT, Huang H, et al · · 2022 · cited 192× · PMID 35750683 · DOI 10.1038/s41392-022-01042-7
Verify or expand the search:
- PubMed search for NCT04056754
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Abiraterone Acetate
Trials testing the same drug.
- NCT06632977 — Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial · Phase 2 · recruiting
- NCT06650579 — REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial · Phase 3 · recruiting
- NCT06369610 — Risk Stratified De-escalated Hormone Therapy With Radiation Therapy for the Treatment of Prostate Cancer · Phase 2 · recruiting
- NCT06120491 — Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice · Phase 3 · recruiting
- NCT04879589 — Phase 1 Study of ATRS-2002 in Healthy Male Adults · Phase 1 · withdrawn
Other recruiting trials for Metastatic Castration Resistant Prostate Cancer
Currently open trials in the same condition.
- NCT07093801 — Observational Study on Lutetium (177Lu) Vipivotide Tetraxetan to Treat Metastatic Castration Resistant Prostate Cancer · recruiting
- NCT06830850 — A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With · Phase 1 · recruiting
- NCT06517719 — Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer · recruiting
- NCT05219500 — Targeted Alpha Therapy With 225Actinium-Prostate Specific Membrane Antigen (PSMA)-I&T of Castration-resISTant Prostate C · Phase 2 · active not recruiting
- NCT04729114 — A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer · Phase 1 · recruiting
Other Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials
Trials by the same sponsor.
- NCT06990776 — A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects · Phase 2 · withdrawn
- NCT06851442 — Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced o · Phase 1, PHASE2 · terminated
- NCT06711991 — A Clinical Trial of TQC3927 Powder for Inhalation in Chronic Obstructive Pulmonary Disease · Phase 1 · completed
- NCT06672276 — To Evaluate the Pharmacokinetics and Safety of TQD3606 for Injection in Subjects With Renal Insufficiency · Phase 1 · completed
- NCT06644417 — Clinical Study of TQA3605 Tablets Combined With Nucleoside (Acid) Analogs (NAs) Drugs Compared With NAs Drugs in the Tre · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04056754 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Last refreshed: 14 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04056754.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing