Using darolutamide for advanced prostate cancer treatment
Addition of Darolutamide to First Line Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC): a Randomized Open Label Phase II Trial
This study is testing if darolutamide can help men with advanced prostate cancer who have already been treated feel better and live longer without their cancer getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 162 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Swiss Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 13 sites (Aarau and 12 other locations) |
| Trial ID | NCT06401980 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of darolutamide, an androgen receptor pathway inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously undergone treatment. The study aims to assess whether maintenance therapy with darolutamide can improve radiographic progression-free survival in this challenging patient population. Participants must have a confirmed diagnosis of prostate cancer and have received at least one line of prior androgen receptor pathway inhibitor therapy. The trial is designed to address the unmet clinical need for effective treatment options in pretreated mCRPC patients.
Who should consider this trial
Good fit: Ideal candidates are men with metastatic castration-resistant prostate cancer who have previously received androgen receptor pathway inhibitors.
Not a fit: Patients who have not received prior androgen receptor pathway inhibitors or those with non-metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival outcomes for patients with advanced prostate cancer.
How similar studies have performed: Previous studies have shown that maintenance treatment with darolutamide can improve outcomes in similar patient populations, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent according to Swiss law and ICH GCP E6(R2) regulations before registration and prior to any trial specific procedures * Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate * Castration resistance: tumor progression after orchiectomy or during treatment with GnRH analogues (agonists or antagonists). * Non-surgically castrated patient agrees on ongoing use of GnRH analogues (agonists or antagonists) during the trial * Metastatic disease, documented by imaging according to PCWG3 criteria * Measurable disease or bone lesions that are evaluable according to PCWG3 criteria * A minimum of 12 months on ADT+ARPI therapy (calculated from ADT initiation) within mHSPC setting, showing an at least 50% PSA response or partial remission according to RECIST v1.1. ARPI change within mHSPC is only allowed for intolerance. * Progressive disease according to modified PCWG3 before registration is defined as (at least 2 out of 3): * PSA progression ≥ 25% above nadir (2 consecutive rises at least 3 weeks apart) * New metastatic lesion on imaging (at least two or more new bone lesions on bone scan or one new non-bone lesion or progression on PSMA-PET/CT according to PROMISE V2 criteria * Clinical progression * Patients with a previously treated malignancy are eligible, when the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low * Age ≥ 18 years * WHO performance status 0-2 * Adequate bone marrow function: absolute neutrophil count ≥ 1.0 x 109/L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 90 g/L. * Adequate hepatic function: total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's disease ≤ 3.0 x ULN), ALT and AST ≤ 2.5 x ULN, or ≤ 5 x ULN under the assumption that abnormal values are a result of cancer * Adequate renal function: estimated glomerular filtration rate (eGFR) \> 30 mL/min/1.73 m2 (according to CKD-EPI formula) * Men agree not to donate sperm or to father a child during trial treatment and until 3 months after the last dose of trial treatment * Patients are able and willing to swallow darolutamide as whole tablet. Exclusion Criteria: * Presence of a small cell component * Prior systemic therapy for metastatic castration-resistant disease * Prior chemotherapy for mHSPC, except docetaxel * Prior LuPSMA or radium 223 for prostate cancer * Concomitant or recent (within 28 days of registration) treatment with any other experimental drug * Concomitant use of other anti-cancer drugs or radiotherapy except for local pain control and GnRH analogues * Severe or uncontrolled cardiovascular disease * Acute exacerbations of chronic illnesses, serious infections, or major surgery within 28 days before expected start of treatment * Clinical or radiological evidence of current spinal cord compression * Any concomitant drugs contraindicated for use with darolutamide according to the approved product information * Known hypersensitivity to darolutamide * Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of darolutamide * Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
Where this trial is running
Aarau and 12 other locations
- Tumorzentrum Aarau TZA — Aarau, Switzerland (Recruiting)
- Kantonsspital Baden — Baden, Switzerland (Recruiting)
- Istituto Oncologico della Svizzera Italiana (IOSI) — Bellinzona, Switzerland (Recruiting)
- Inselspital — Bern, Switzerland (Recruiting)
- Kantonsspital Graubuenden — Chur, Switzerland (Recruiting)
- Hôpitaux Universitaires Genève HUG — Geneva, Switzerland (Recruiting)
- Centre Hospitalier Universitaire Vaudois CHUV — Lausanne, Switzerland (Recruiting)
- Luzerner Kantonsspital — Lucerne, Switzerland (Recruiting)
- Kantonsspital St. Gallen — Sankt Gallen, Switzerland (Recruiting)
- Kantonsspital Winterthur — Winterthur, Switzerland (Recruiting)
- OnkoZentrum Zürich - Standort Seefeld — Zurich, Switzerland (Recruiting)
- Stadtspital Triemli Zürich — Zurich, Switzerland (Recruiting)
- UniversitaetsSpital Zuerich — Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Simone Rahel Wyss-Neyer
- Email: trials@swisscancerinstitute.ch
- Phone: +41 31 389 91 91
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.