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Darolutamide+ADT Post-RP w/o ePLND in hrPC: Briganti 2019

NCT07282197 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-15

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate whether adjuvant darolutamide plus androgen-deprivation therapy (ADT) can reduce post-operative recurrence and improve disease control in high-risk prostate cancer patients-defined by the Briganti 2019 nomogram-who have undergone radical prostatectomy (RP) without extended pelvic lymph node dissection (ePLND). The main questions it aims to answer are:

1. What proportion of participants remains biochemical-recurrence-free at 2 years, using NCCN criteria (PSA increase \>0.1 ng/mL above post-treatment nadir confirmed by two tests ≥2 weeks apart)?
2. What proportion of participants is the 2-year radiographic progression-free survival (rPFS)?

Additional key outcomes include:

* PSA undetectable rates at 6, 12, and 24 months (PSA \<0.01 ng/mL).
* Safety and tolerability assessed by CTCAE v5.0.
* Exploratory\*\* patient-reported outcomes: urinary symptoms (IPSS) and quality of life (EQ-5D-3L).

Study type \& design: Phase II, single-center, single-arm, prospective interventional study. Enrollment occurs within 12 weeks after RP. ADT is delivered with a GnRH agonist (physician's choice); orchiectomy is excluded. Target sample size is approximately 40 participants; the statistical plan uses a one-sample log-rank framework. Primary and secondary endpoints are assessed over 2 years.

Participants will: Provide informed consent and undergo eligibility confirmation (high-risk per Briganti 2019; post-RP without ePLND; enrollment ≤12 weeks after surgery). Receive darolutamide + ADT according to protocol (GnRH agonist; no orchiectomy). Attend scheduled visits for PSA monitoring, safety labs, and adverse-event assessments (CTCAE v5.0). Undergo radiologic evaluations as per protocol to determine rPFS (RECIST 1.1/PCWG3). Complete IPSS and EQ-5D-3L questionnaires at specified time points to assess urinary symptoms and quality of life.

Primary endpoint: 2-year biochemical-recurrence-free rate. Key secondary endpoints: 2-year rPFS; PSA \<0.01 ng/mL at 6/12/24 months; treatment-emergent adverse events.

Exploratory endpoints: IPSS and EQ-5D-3L changes over 2 years.

This trial aims to balance oncologic control with quality of life in a population for whom the therapeutic value of ePLND remains uncertain, by testing whether early adjuvant darolutamide + ADT after RP can meaningfully delay recurrence and progression while maintaining acceptable tolerability.

Conditions

Interventions

DRUG

Darolutamide (BAY 1841788)

Darolutamide 600 mg bid + ADT x 12 months

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Kan Gong · Peking University First Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2029-03-31
Completion
2029-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07282197 on ClinicalTrials.gov