Using darolutamide for advanced prostate cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Stefanie Röthlisberger Röthlisberger, PhD
• Email: trials@swisscancerinstitute.ch
• Phone: +41 31 389 91 91

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• JUR-003 in adults with advanced prostate cancer

  This first-in-human study tests JUR-003 to see if it is safe and tolerable and to get an early sense of activity in adults with metastatic or advanced prostate cancer.

  Recruiting at 4 sites Phase 1 TCG Labs Soleil · Grand Rapids, Michigan and 3 other locations · NCT07824349

• SRT-017 radioligand therapy in PSMA-positive metastatic castration-resistant prostate cancer

  This study tests SRT-017 given by IV infusion to men with PSMA-positive metastatic castration-resistant prostate cancer to see if it is safe and tolerable and to gather early signals of anti-tumor activity.

  Recruiting Early Phase 1 Affiliated Hospital of Jiangnan University · Wuxi, Jiangsu · NCT07798778

• Rinzimetostat plus darolutamide in metastatic castration-resistant prostate cancer after abiraterone failure

  This study tests whether adding rinzimetostat to darolutamide helps people with metastatic castration-resistant prostate cancer who previously took abiraterone.

  Recruiting at 15 sites Phase 3 ORIC Pharmaceuticals · Glendale, California and 14 other locations · NCT07723248

• FX-111 safety and pharmacokinetics in metastatic castration-resistant prostate cancer

  This study tests whether FX-111 is safe and can help treat metastatic castration-resistant prostate cancer in adult men.

  Recruiting at 7 sites Phase 1 Flare Therapeutics Inc. · Los Angeles, California and 9 other locations · NCT07719361

• Docetaxel and SX-682 in head and neck cancers and prostate cancer

  This trial tests a new drug SX-682 together with docetaxel in adults whose head and neck cancers or prostate cancer have returned or spread.

  Recruiting Phase 1/2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07667400

• Dual-target PSMA/PSCA CAR-NK Therapy in Advanced Prostate Cancer

  This trial tests ETB-DualNK-01, a dual-target CAR-NK cell therapy, in adults with metastatic castration-resistant prostate cancer to see if it is safe and shows early signs of activity.

  Recruiting Phase 1 Beijing Biotech · Shenzhen, Guangdong · NCT07641049

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.