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NCT06865547: ProA

ProA Study: ProActive Management Model in Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated by Apalutamide

ENROLLING BY INVITATION Last updated 10 March 2025
What this trial tests

trial testing The 4A ProActive Management Model in Prostate Cancer (Adenocarcinoma) in 94 participants. Enrolling by invitation.

Timeline
22 January 2025
Primary endpoint
30 January 2026
30 August 2026

Quick facts

Lead sponsorYonghong Li
StatusENROLLING BY INVITATION
Study typeOBSERVATIONAL
Enrollment94
Start date22 January 2025
Primary completion30 January 2026
Estimated completion30 August 2026
Sites1 location across China

Drugs / interventions tested

Conditions studied

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.

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Data sources for this page

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.

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