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NCT05627752
Docetaxel Alone or in Combination With Enzalutamide for mCRPC Previously Treated With Abiraterone at mHSPC Stage
Phase 2, PHASE3 trial testing Enzalutamide 40 MG in Prostate Cancer in 120 participants. Status unknown.
31 December 2025
Quick facts
| Lead sponsor | Zhongnan Hospital |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 1 June 2024 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 2 locations across China |
Drugs / interventions tested
- Enzalutamide 40 MG — full drug profile →
- Docetaxel injection — full drug profile →
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
- Castrate Resistant Prostate Cancer — all drugs for Castrate Resistant Prostate Cancer →
Sponsor
Zhongnan Hospital
Who can join
Adults 18 to 75, male only, with Prostate Cancer or Castrate Resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
New androgen pathway targeting agents (ARTA), including Abiraterone acetate, Apalutamide and Enzalutamide, are approved and used in treatment of metastatic hormonal sensitive prostate cancer(mHSPC). However, the development of castration-resistance prostate cancer(CRPC) is only a matter of time. The use of sequential ARTAs in mCRPC showed limited benefit in retrospective series and prospective trials. Therefore this sequence should be avoided because of known cross resistance and the availability of chemotherapy and poly adenosine diphosphate-ribose polymerase(PARP) inhibitors (if a relevant mutation is present). Recently, a randomized controlled trial(RCT), the ABIDO-SOGUG, indicated that compared with docetaxel, maintaining Abiraterone added to docetaxel in chemotherapy-naive patients who have experienced cancer progression to Abiraterone treatment could not improve radiographic progression-free survival or the other endpoints.However, another RCT, the PRESIDE trial, indicated that in patients who had progressed on Enzalutamide, continued Enzalutamide treatment in combination with docetaxel led to a significant improvement of PFS compared with placebo plus docetaxel. The aims of this trial is to assess both the efficacy and safety of docetaxel in combination with Enzalutamide as first-line treatment in mCRPC patients progressed on Abiraterone.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05627752
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Other Zhongnan Hospital trials
Trials by the same sponsor.
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- NCT07363330 — A Phase II Study of Utidelone With Toripalimab in Advanced Cervical Cancer · Phase 2 · not yet recruiting
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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 NCT05627752 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zhongnan Hospital
- Last refreshed: 28 February 2024
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/NCT05627752.
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