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

NCT07282197 | Not Yet Recruiting Phase 2

• 1 other identifier: 23096
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who remained biochemical recurrence free for 2 years

  biochemical recurrence defined as a PSA increase \>0.1 ng/ml above the post-treatment nadir (confirmed by two consecutive measures at least 2 weeks apart), according to NCCN criteria

  2 years

Secondary Outcomes (3)

• 2-year rate of radiological progression-free survival (rPFS)

  2 years

• 6-month/ 12-month/ 24-month PSA undetectable rate

  2 years

• TEAEs

  2 years

Other Outcomes (2)

• Changes in urinary symptoms

  2 years

• PRO

  2 years

Study Arms (1)

Daro+ADT

EXPERIMENTAL

High-risk prostate cancer patients (Briganti 2019 monogram criteria) who did not undergo extended pelvic lymph node dissection (ePLND), will receive Darolutamide 600 mg bid + ADT for 12 months within 12 weeks after RP.

Drug: Darolutamide (BAY 1841788)

Interventions

Darolutamide (BAY 1841788) DRUG

Darolutamide 600 mg bid + ADT x 12 months

Daro+ADT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient volunteers to participate and signs the informed consent form (ICF);
• Age 18-75 years (inclusive), male;
• Histologically or cytologically confirmed prostatic adenocarcinoma;
• No non-regional lymph-node metastasis, bone metastasis, or other distant metastasis (e.g., visceral) by conventional imaging (bone scan, CT or MRI) or by PET/CT; i.e., M0;
• High-risk per the Briganti 2019 nomogram, i.e., risk \>7%;
• PSA \<0.1 ng/mL at 6 weeks after radical prostatectomy (RP);
• Has undergone RP without pelvic lymph-node dissection;
• Not suitable for adjuvant/salvage radiotherapy (RT) after RP, or the patient declines RT;
• Patients with lymph-node involvement (LNI) indicated by PSMA-PET who did not undergo extended pelvic lymph-node dissection (ePLND) may be enrolled;
• Patients with negative intraoperative obturator lymph-node biopsy who did not undergo ePLND may be enrolled;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
• Adequate hematologic and organ function:
• Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L (1500/µL);
• Hemoglobin ≥90 g/L (9.0 g/dL);
• Platelet count ≥100 × 10⁹/L (100,000/µL) (without transfusion and/or growth factors within 3 months prior to starting study treatment);

You may not qualify if:

• Histologic features of neuroendocrine differentiation or small-cell carcinoma;
• Prior prostate cancer treatments including any of the following:
• Systemic therapy, including but not limited to: \>2 months of ADT; \>2 months of conventional hormonal therapy (e.g., flutamide, bicalutamide); next-generation hormonal agents (e.g., darolutamide, abiraterone, apalutamide, enzalutamide, relugolix); chemotherapy (e.g., docetaxel); immunotherapy; targeted therapy;
• Local radiotherapy;
• Planned bilateral orchiectomy during the study treatment period;
• Inability to tolerate darolutamide or ADT;
• Concurrent participation in, or planned participation in, another clinical trial;
• A malignancy other than prostate cancer within the past 5 years or concurrently, except for cured basal cell carcinoma of the skin;
• Any concomitant disease or condition that, in the investigator's judgment, presents a serious risk to patient safety, may confound study results, or may interfere with completion of the study (e.g., severe cardiovascular disease, active infection, gastrointestinal disease, neurologic or psychiatric disorders, etc.);
• Any other condition deemed by the investigator to make the patient unsuitable for this study.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

darolutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Kan Gong

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kan Gong

CONTACT

(86)-010-83572075; kan.gong@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: December 15, 2025

Record last verified: 2025-10

Locations

CN (1)