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Recruiting NCT06177015

Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC

Phase III Interventional Metastatic Prostate Cancer Intermitent Anti-androgen Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Darolutamide continuous, Darolutamide intermittent.
Who it may be relevant to
Registry conditions: Metastatic Prostate Cancer, Intermitent Anti-androgen Therapy. Basic parameters: 40 years — 80 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized Controlled Study on the Efficacy and Safety of Intermittent Darolutamide Treatment in the Triple Therapy of Metastatic Hormone Sensitive Prostate Cancer

Overview

To evaluate the efficacy and safety of intermittent use of darolutamide compared to long-term use in combination with ADT and docetaxel in the treatment of mHSPC patients.

Detailed description

Patients will firstly receive 6 months of darolutamide in combination with docetaxel and ADT treatment.

1\. When the patient reaches:

1. PSA ≤ 0.2ng/ml 2. Or PSA \> 0.2ng/ml but with more that 90% decrease comparing baseline 3. Without newly discovered metastatic lesions. They will be randomly assigned in a 1:1 ratio to either continuous treatment group or intermittent treatment group (1) Continuous treatment group: Darolutamide: 600mg, bid+ADT: Leuprorelin (3.6mg qm or 10.8mg q3m) or goserelin 80mg qm until mCRPC; (2) Intermittent treatment group: Only ADT as background treatment without Darolutamide. PSA check every three months, when the patient's PSA \> 1ng/ml (or PSA \> 1ng/ml and PSA has risen by more than 20% comparing baseline), restart the darolutamide, until mCRPC.

2\. When the patient:

1. PSA \> 0.2ng/ml and has not decreased by 90% compared to baseline 2. Or has new metastatic lesions, they will exit the study. Imaging assessment will be conducted every 3 months

Interventions

  • Drug Darolutamide continuous
    standard of care
  • Drug Darolutamide intermittent
    experimental group

Primary outcome measures

  • Radiographic Progression Free Survival [Time frame: 36 months]
  • Overall Survival [Time frame: 36 months]
Secondary outcome measures (2)
  • Time to castration-resistant prostate cancer [Time frame: 36 months]
  • Time to pain progression [Time frame: through study completion, an average of 3 year]

Eligibility criteria

Inclusion criteria

Patients must meet all of the following criteria to be eligible for this study:

  • Male aged ≥18 years;
  • Histologically or cytologically confirmed prostate adenocarcinoma;
  • Metastatic disease (confirmed by conventional imaging);
  • ECOG performance status of 0-1;
  • Suitable for ADT and docetaxel treatment;
  • Good bone marrow, kidney, and liver function:

1\. (1) Hematological examination (no blood transfusion or use of hematopoietic growth factors within 7 days before screening):

1\. Hemoglobin (HB) ≥ 90g/L; 2. Absolute neutrophil count (ANC) ≥ 1.5×109/L; 3. Platelets (PLT) ≥ 80×109/L; 2. (2) Blood biochemistry examination (no blood transfusion or albumin within 7 days before screening):

  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN
  • Total bilirubin (TBIL) ≤ 2.0 × ULN;
  • Serum creatinine (Cr) ≤ 2.0×ULN;

7\. Willing to participate in this study, sign an informed consent form, and have good compliance

Exclusion criteria

  • No metastatic disease;
  • Prior treatment with: a) Second-generation ARis or other experimental ARis b) CYP17 enzyme inhibitors such as abiraterone acetate or oral ketoconazole for anti-tumor treatment of prostate cancer c) Chemotherapy or immunotherapy prior to randomization for prostate cancer
  • Received radiotherapy within 2 weeks before starting 6 months of darolutamide + docetaxel + ADT treatment;
  • Stroke, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass surgery, congestive heart failure (New York Heart Association class III or IV);
  • History of malignant tumors;
  • Planned receipt of other anti-tumor treatment during the study treatment period;
  • Known allergy to the above drug components;
  • Difficulty swallowing, chronic diarrhea, intestinal obstruction, and various factors affecting drug intake and absorption;
  • Refusal to sign the informed consent form;
  • Investigator's opinion that the participant is not suitable for inclusion.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Urology dpt, First Affiliated Hospital of Nanjing Medical University — Nanjing

Identifiers

NCT: NCT06177015 · 2023-SR-662

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗