Evaluation of the Efficacy and Safety of Darolutamide + ADT Combined With Low-dose Docetaxel in mHSPC

ConditionmHSPC

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexMale

Age18+

SponsorYonghong Li

About this trial

This is a single-arm, prospective, multicenter, interventional study, aimed at exploring the efficacy and safety of darolutamide + ADT combined with low-dose docetaxel in treating patients with mHSPC planning to recruit approximately 109 patients.

The purpose of this study is to investigate the proportion of patients who reach PSA undetectable (PSA\< 0.2ng/ml) at the primary analysis (24 weeks). According to the ARASENS study, the percentage of undetectable PSA in the experimental arm in the Chinese subset at 24 weeks is 46.2%. This study calculates that it is possible to maintain the therapeutic efficacy of PSA while reducing the dose of docetaxel.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent

Males ≥18 years of age

Histologically or cytologically confirmed adenocarcinoma of prostate

Metastatic disease documented either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by Investigator and confirmed by central radiology review

Disqualifiers

LHRH agonist/antagonists started more than 12 weeks before before the initiation of study

Second-generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide, other investigational AR inhibitors

Cytochrome P 17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer

Chemotherapy or immunotherapy for prostate cancer prior to randomization 2. Treatment with radiotherapy (external beam radiation therapy, brachytherapy, or radiopharmaceuticals) within 2 weeks before initiation of study 3. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs

Trial design

Design model

Single group

Treatments tested in this trial

Darolutamide + ADT Combined with Low-dose Docetaxel
Drug
1. Darolutamide This study used Darolutamide from Bayer Pharmaceuticals, with a specification of 300mg per tablet. The dose is 600 mg （2 tablets）, taken twice a day with meals. 2. Docetaxel The dose of docetaxel is 60mg/m2, administered intravenously on the first day of each cycle. This cycle should be repeated every 3 weeks for a maximum of 6 cycles. Docetaxel can be administered in combination with prednisone/prednisolone at the discretion of the researcher. To prevent hypersensitivity and fluid retention.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

Undetectable PSA(<0.2ng/ml) at 24w

Time frame

6 months

Undetectable PSA(<0.2ng/ml) at 24w

Defined as the ratio of the number of subjects whose PSA less than 0.2ng/ml to the total number of subjects whose PSA response can be evaluated within 24 weeks

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yonghong Li

Lead sponsor

Sun Yat-sen University

Sponsor institution

Source ClinicalTrials.gov

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