Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC

NCT06177015 | Recruiting Phase 3

• 1 other identifier: 2023-SR-662
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Prostate Cancer; Intermitent Anti-androgen Therapy

Keywords

triple treatment regimen; mHPSC; Darolutemide

Outcome Measures

Primary Outcomes (2)

• Radiographic Progression Free Survival

  rPFS

  36 months

• Overall Survival

  OS

  36 months

Secondary Outcomes (2)

• Time to castration-resistant prostate cancer

  36 months

• Time to pain progression

  through study completion, an average of 3 year

Study Arms (2)

Continuous treatment group

ACTIVE COMPARATOR

Darolutamide: 600mg, bid+ADT: Leuprorelin (3.6mg qm or 10.8mg q3m) or goserelin 80mg qm until mCRPC

Drug: Darolutamide continuous

Intermittent treatment group

EXPERIMENTAL

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.

Drug: Darolutamide intermittent

Interventions

Darolutamide continuous DRUG

standard of care

Also known as: Darolutamide

Continuous treatment group

Darolutamide intermittent DRUG

experimental group

Also known as: Darolutamide

Intermittent treatment group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) Hematological examination (no blood transfusion or use of hematopoietic growth factors within 7 days before screening):
• \. 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;
• \. Willing to participate in this study, sign an informed consent form, and have good compliance

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Urology dpt, First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

darolutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Lixxin Hua

  Urology Dpt, First Affiliated Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shangqian Wang

CONTACT

+862568303186; wsq5501@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: Two independent arms

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: December 11, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)