Using Darolutamide with hormone therapy for men with localized prostate cancer

A Phase II, Multi-center, Single-arm, Prospective Study of Darolutamide + ADT Prior to Radical Prostatectomy (RP) in High-risk/Very High-risk Localized Prostate Cancer

This study is testing if adding Darolutamide to hormone therapy can help men with high-risk localized prostate cancer shrink their tumors before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Male
• Sponsor: Peking University First Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Beijing)
• Trial ID: NCT06029036 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of Darolutamide combined with androgen deprivation therapy (ADT) in men diagnosed with high-risk localized prostate cancer. The primary goal is to measure the reduction in tumor volume and pathological downstaging after patients undergo radical prostatectomy and pelvic lymph-node dissection. Participants must meet specific criteria indicating high-risk features of their cancer, and the study aims to provide insights into the potential benefits of this novel hormone therapy approach in the neoadjuvant setting.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 and older with non-metastatic adenocarcinoma of the prostate and high-risk features as defined by specific clinical criteria.

Not a fit: Patients with metastatic prostate cancer or those who do not meet the high-risk criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to improved outcomes and reduced recurrence rates for men with high-risk localized prostate cancer.

How similar studies have performed: Other studies have shown promising results with similar hormone therapy approaches in advanced stages of prostate cancer, suggesting potential for success in this neoadjuvant context.

Eligibility criteria

Inclusion Criteria:

1. Male ≥18 years of age.
2. Able to Sign informed consent form independently.
3. Non-metastatic adenocarcinoma of the prostate.
4. Subjects must have as least one of the following features according to NCCN definition of high-risk: Gleason score ≥8, or PSA \>20ng/ml,or≥clinical T3a.
5. Subjects with pelvic lymph node involvement(N1) can be included.
6. Candidate for radical prostatectomy with or without pelvic lymph node dissection as per the investigator.
7. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
8. Subjects must have normal organ and marrow function as defined below:

Hemoglobin ≥ 9.0 g/dL;Absolute neutrophil count (ANC) ≥ 1,500/mcL; Platelets ≥ 100,000/mcL, independent of transfusions/growth factors within 3 months of treatment start; Serum potassium ≥ 3.5 mmol/L; Serum total bilirubin ≤ 2.0 x upper limit of normal (ULN) (except in subjects with Gilbert's syndrome who have a total bilirubin \> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible);Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN;Serum albumin ≥ 3.0 g/dL;Serum creatinine \< 2.0 x ULN.

Exclusion Criteria:

1. Prostate cancer with neuroendocrine differentiation or small cell features
2. Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.
3. History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer.
4. Subjects who are planning bilateral orchidectomy during the treatment period of the study.
5. Intolerable with darolutamide or ADT treatment.
6. Candidates of other clinical trials.
7. Any prior malignancy within 5 years.
8. Complications include significant cardiovascular disease, active infection, astrointestinal disorders, or any other complications that in the opinion of the investigator.
9. Any condition that in the opinion of the investigator would preclude participation in this study.

Where this trial is running

Beijing

• Peking University First Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Zhisong He, MD

Conditions Prostate Cancer