Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC

NCT ID: NCT06177015

Last Updated: 2023-12-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-11
• Study Completion Date: 2027-12-31

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.

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

Conditions

Metastatic Prostate Cancer; Intermitent Anti-androgen Therapy

Keywords

triple treatment regimen; mHPSC; Darolutemide

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Continuous treatment group

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

Group Type: ACTIVE_COMPARATOR

Darolutamide continuous

Intervention Type: DRUG

standard of care

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.

Group Type: EXPERIMENTAL

Darolutamide intermittent

Intervention Type: DRUG

experimental group

Interventions

Darolutamide continuous

standard of care

Intervention Type: DRUG

Darolutamide intermittent

experimental group

Intervention Type: DRUG

Other Intervention Names

Darolutamide; Darolutamide

Eligibility Criteria

Inclusion Criteria

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

1. Male aged ≥18 years;

2. Histologically or cytologically confirmed prostate adenocarcinoma;

3. Metastatic disease (confirmed by conventional imaging);

4. ECOG performance status of 0-1;

5. Suitable for ADT and docetaxel treatment;

6. 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):

1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN

2. Total bilirubin (TBIL) ≤ 2.0 × ULN;

3. Serum creatinine (Cr) ≤ 2.0×ULN;

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

Exclusion Criteria

1. No metastatic disease;

2. 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

3. Received radiotherapy within 2 weeks before starting 6 months of darolutamide + docetaxel + ADT treatment;

4. Stroke, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass surgery, congestive heart failure (New York Heart Association class III or IV);

5. History of malignant tumors;

6. Planned receipt of other anti-tumor treatment during the study treatment period;

7. Known allergy to the above drug components;

8. Difficulty swallowing, chronic diarrhea, intestinal obstruction, and various factors affecting drug intake and absorption;

9. Refusal to sign the informed consent form;

10. Investigator's opinion that the participant is not suitable for inclusion.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hua Lixin

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lixxin Hua

Role: PRINCIPAL_INVESTIGATOR

Urology Dpt, First Affiliated Hospital of Nanjing Medical University

Locations

Urology dpt, First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shangqian Wang

Role: CONTACT

Phone: +862568303186

Email: wsq5501@126.com

Facility Contacts

Shangqian Wang, M.D.,PhD.

Role: primary

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

2023-SR-662

Identifier Type: -

Identifier Source: org_study_id