NCT06865547

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 94 (estimated)
• Sponsor: Yonghong Li · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Prostate Cancer (Adenocarcinoma)

Interventions

Type	Name	Description
BEHAVIORAL	The 4A ProActive Management Model	This model focuses on four key areas - Active Education, Active Prevention Strategies, Active Management, and Active Follow-up. Active Education involves providing patients with detailed information on treatment regimens, potential AEs, and self-care through verbal education, reminder cards, and direct counseling. Active Prevention Strategies aims to directly reduce risks through nursing care bundles that incorporate supportive medications, fall risk assessments, and dietary guidance. Active Management establishes robust protocols for early AE reporting, rapid treatment, and standardized order sets. Active Follow-up comprises additional outpatient visits, patient surveys, medication refill coordination, and pharmacist/nurse follow-up calls to closely monitor patient adherence and symptoms.

Timeline

• Start date: 2025-01-22
• Primary completion: 2026-01-30
• Completion: 2026-08-30
• First posted: 2025-03-10
• Last updated: 2025-03-10

Locations

1 site across 1 country: China