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Non-metastatic castration-resistant prostate cancer

Bayer Identifier:
23126
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
An observational study conducted in China to evaluate the efficacy and safety of darolutamide in combination with androgen deprivation therapy (ADT) for men with non-metastatic prostate cancer that progressed following prior bicalutamide + ADT treatment

Trial purpose

In this observational study, participants receive darolutamide: a treatment that is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC).

Prostate cancer is a common cancer in men, and the number of cases is rising, especially in China. Many men are diagnosed at a late stage, which makes treatment more difficult. Standard treatment for prostate cancer often includes lowering the levels of male hormones (androgens) in the body, as these hormones can help the cancer grow. This is called androgen deprivation therapy (ADT). Sometimes, medicines like bicalutamide are added to ADT, but over time, the cancer can become resistant to these treatments. When this happens and the cancer has not yet spread to other parts of the body, it is called nmCRPC. Newer agents, such as darolutamide, have demonstrated efficacy in controlling the disease and delaying progression, with a more favorable safety profile and fewer severe adverse events than conventional therapies.

This study wants to observe how effective darolutamide plus ADT is at controlling the cancer in Chinese men with nmCRPC who have already been treated with bicalutamide plus ADT during an earlier stage of their disease, known as non-metastatic hormone-sensitive prostate cancer (nmHSPC), but whose cancer has since progressed despite that treatment.

The study will look at how many participants have their prostate-specific antigen (PSA) levels drop to undetectable levels within 6 months of starting darolutamide (in the main group of 800 participants). PSA is a protein made by the prostate, and high levels can be a sign of prostate cancer. In a smaller group of 100 participants, the study will also look at how many men remain free from PSA progression (a sign that the cancer is not getting worse) after 12 months.

To learn more about the safety of darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants.

Key Participants Requirements

Sex

Male

Age

18 - N/A
    • Males Age ≥ 18 years.
    • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
    • Patients receiving ≥6 m ADT+Bicalutamide in nmHSPC, progressed to nmCRPC judged by investigators.
    • Serum testosterone level<1.7 nmol/L.
    • Decision to initiate treatment with ADT + Darolutamide as per investigator’s routine treatment practice.
    • No evidence of metastasis as assessed by computed tomography (CT)/magnetic resonance imaging (MRI) for soft tissue disease and whole-body radionuclide bone scan for bone disease.
    • The informed consent form must be signed by the patient or his legal guardian (as applicable).
    • Patients who are fertile must use an effective method of contraception during the study and must refrain from donating sperm during the study or for 3 months after the end of treatment, unless they have undergone a radical prostatectomy.
    • Participation in an investigational program with interventions outside of routine clinical practice.
    Presence of distant metastases, including involvement of the Central Nervous System (CNS) and vertebral or meningeal involvement.
    • Symptomatic local or regional lesions requiring medical intervention (moderate or severe urinary tract obstruction or hydronephrosis caused by the primary tumor).
    • Previous treatment with 2nd-generation ARIs.
    • Previous treatment with CYP17 inhibitors.
    • Previous treatment with radiopharmaceuticals, immunotherapy, or other investigational treatment for nmCRPC.
    • Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events, or clinically significant ventricular arrhythmias.
    • Gastrointestinal diseases affecting absorption.

Trial summary

Enrollment Goal
800
Trial Dates
June 2026 - January 2030
Phase
Phase 4
Could I Receive a placebo
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Not yet recruiting
Many locationsMany locations, China

Primary Outcome

  • Proportion of patients with prostatic specific antigen (PSA) undetectable within 6 months (Master Cohort)
    The proportion of patients with undetectable PSA at any time within the 6 months after treatment initiation, undetectable PSA is defined as an absolute PSA level <0.2 ng/ml
    date_rangeTime Frame:
    up to 6 months
  • Proportion of patients with PSA Progression Free Survival (PSA-PFS) rate at 12 months (Sub-cohort)
    The proportion of patients who remain PSA progression free by 12 months. PSA progression: (i) PSA increase of≥ 25% and an absolute increase of≥2 ng/mL above the nadir, which is confirmed by a second value obtained 3 or more weeks later, in case of decline, or (ii) a PSA increase of≥25%, and an absolute increase of≥ 2 ng/mL after 12 weeks in case of no decline from the baseline.
    date_rangeTime Frame:
    up to 12 months

Secondary Outcome

  • Proportion of patients with PSA50 within 3 months (Master cohort)
    The proportion of patients who achieve 50% or more decline from baseline PSA, at any time within 3 months of treatment initiation
    date_rangeTime Frame:
    Up to 3 months
  • Proportion of patients with PSA50 within 6 months (Master cohort)
    The proportion of patients who achieve 50% or more decline from baseline PSA, at any time within 6 months of treatment initiation
    date_rangeTime Frame:
    Up to 6 months
  • Proportion of patients with PSA90 within 3 months (Master cohort)
    The proportion of patients who achieve 90% or more decline from baseline PSA, at any time within 3 months of treatment initiation
    date_rangeTime Frame:
    Up to 3 months
  • Proportion of patients with PSA90 within 6 months (Master cohort)
    The proportion of patients who achieve 90% or more decline from baseline PSA, at any time within 6 months of treatment initiation
    date_rangeTime Frame:
    Up to 6 months
  • Proportion of patients with PSA undetectable within 3 months (Master cohort)
    The proportion of patients with undetectable PSA at any time within the 3 months of treatment initiation, undetectable PSA is defined as an absolute PSA level <0.2 ng/ml
    date_rangeTime Frame:
    Up to 3 months
  • Proportion of patients with PSA50/90 within 12 months (Sub-cohort)
    The proportion of patients who achieve 50%/90% or more decline from baseline PSA, at any time within the 12 months of treatment initiation
    date_rangeTime Frame:
    Up to 12 months
  • Proportion of patients with PSA undetectable within 12 months (Sub-cohort)
    The proportion of patients with undetectable PSA at any time within the 12 months of treatment initiation, undetectable PSA is defined as an absolute PSA level <0.2 ng/ml
    date_rangeTime Frame:
    Up to 12 months
  • Metastasis-free survival (MFS) rate at 12 months (Sub-cohort)
    The proportion of patients who remain metastasis-free by 12 months. MFS is defined as time between the start of the first darolutamide treatment and evidence of metastasis (bone metastasis, visceral metastasis, distant lymph node metastasis) or death from any cause
    date_rangeTime Frame:
    Up to 12 months
  • Proportion of patients with Treatment Emergent Adverse Events (Master and Sub-cohort)
    Frequency and severity according to CTCAE v.6, seriousness, causality and action taken related to darolutamide treatment
    date_rangeTime Frame:
    Up to 12 months

Trial design

A Multicenter, Real-world Study Evaluating the Effectiveness of Darolutamide Plus ADT in Patients Progressing to nmCRPC After Bicalutamide Plus ADT Treatment During nmHSPC Stage
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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