Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC

Metastatic Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06177015
• Other study ID #: 2023-SR-662
• Status: Recruiting
• Phase: Phase 3
• Start date: December 11, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Shangqian Wang
• Phone: +862568303186
• Email: wsq5501[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Urology dpt, First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic Progression Free Survival	rPFS	36 months
Primary	Overall Survival	OS	36 months
Secondary	Time to castration-resistant prostate cancer	Time to mCRPC	36 months
Secondary	Time to pain progression	TTPP	through study completion, an average of 3 year