Spots Global Cancer Trial Database for Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC

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Trial Identification

Brief Title: Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC

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

Study ID: NCT06177015

Conditions

Metastatic Prostate Cancer

Intermitent Anti-androgen Therapy

Interventions

Darolutamide continuous

Darolutamide intermittent

Study Description

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