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Clinical Trials/2024-512132-29-00
2024-512132-29-00
Not yet recruiting
Phase 2

SAKK 08/23: Addition of Darolutamide to first line treatment of mCRPC: a randomized open label phase II trial

Swiss Group for Clinical Cancer Research20 sites in 1 country100 target enrollmentStarted: May 22, 2025Last updated:
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Overview

Phase
Phase 2
Status
Not yet recruiting
Enrollment
100
Locations
20
Primary Endpoint
Radiographic progression-free survival.
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The main objective is to assess the efficacy of darolutamide, used in addition to physician-choice standard of care and then in maintenance therapy, on radiographic progression-free survival (rPFS) for patients in the first line setting of mCRPC.

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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
  • •Prior response to ARPI for at least 12 months in the mHSPC setting.
  • •Adequate bone marrow, hepatic and renal functions.

Exclusion Criteria

  • •Presence of a small cell component.
  • •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 may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
  • •Prior systemic therapy for metastatic castration-resistant disease.
  • •Prior chemotherapy for mHSPC, except docetaxel.
  • •Prior LuPSMA or radium 223 for prostate cancer.
  • •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 before start of treatment.
  • •Clinical or radiological evidence of current spinal cord compression.

Outcomes

Primary Outcomes

Radiographic progression-free survival.

Radiographic progression-free survival.

Secondary Outcomes

  • Overall survival.
  • Time to symptomatic/clinical progression.
  • Time to PSA progression (defined according to PCWG3).
  • Event-free survival (EFS) – event being defined as one of the following: - death from any cause - presence of radiographic progression and symptomatic/clinical progression; - presence of radiographic progression and PSA progression; - presence of symptomatic/clinical progression and PSA progression
  • Objective response rate according to RECIST.
  • PSA response (30%, 50%, 90% and best).
  • Duration of PSA response (50%).
  • AEs.

Investigators

Sponsor Class
Patient organisation/association
Responsible Party
Principal Investigator
Principal Investigator

Richard Cathomas

Scientific

Swiss Group for Clinical Cancer Research

Study Sites (20)

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