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NCT06865547: ProA
ProA Study: ProActive Management Model in Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated by Apalutamide
trial testing The 4A ProActive Management Model in Prostate Cancer (Adenocarcinoma) in 94 participants. Enrolling by invitation.
30 January 2026
Quick facts
| Lead sponsor | Yonghong Li |
|---|---|
| Status | ENROLLING BY INVITATION |
| Study type | OBSERVATIONAL |
| Enrollment | 94 |
| Start date | 22 January 2025 |
| Primary completion | 30 January 2026 |
| Estimated completion | 30 August 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- The 4A ProActive Management Model
Conditions studied
- Prostate Cancer (Adenocarcinoma) — all drugs for Prostate Cancer (Adenocarcinoma) →
Sponsor
Yonghong Li
Who can join
18 and older, male only, with Prostate Cancer (Adenocarcinoma). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 4, multi-center, single arm, open-label clinical study to evaluate whether participants with mHSPC treated with apalutamide will benefit from the 4A ProActive Management Model. The study will include a Screening Period of up to 14 days before assignment on Day 1 to establish study eligibility. Participants will get 4A ProActive Management according to the protocol . As the background disease treatment, participants will received apalutamide according to local label (240 mg, 4 × 60 mg tablets, orally once daily with or without food) with duration of at least 6 months. Participants will have a Safety Follow-Up Visit within 30 days after the Visit 7. Participants will be monitored for safety, starting from the time of signing the informed consent until 30 days after the Visit 7. AEs including laboratory AEs will be graded and summarized using Version 5.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06865547
- Europe PMC full search
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Related trials
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- NCT07302451 — REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients) · Phase 2 · active not recruiting
- NCT07115914 — PSMA PET for Surveillance After Focal Therapy · NA · recruiting
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 NCT06865547 (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 Yonghong Li
- Last refreshed: 10 March 2025
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/NCT06865547.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing