NCT07503379

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for phase_2

Timeline
30mo left

Started Apr 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Apr 2026Dec 2028

First Submitted

Initial submission to the registry

March 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

March 25, 2026

Last Update Submit

March 25, 2026

Conditions

mHSPC

Outcome Measures

Primary Outcomes (2)

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

    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

    6 months

Interventions

Darolutamide + ADT Combined with Low-dose DocetaxelDRUG

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.

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Subjects must be candidates for ADT and docetaxel therapy per Investigator's judgment
  • Started ADT (LHRH agonist/antagonist or orchiectomy) with or without first generation anti-androgen, but no longer than 12 weeks before included. For subjects receiving LHRH agonists, treatment in combination with a first generation anti-androgen for at least 4 weeks before the initiation of study is recommended. First generation anti-androgen has to be stopped prior to included.
  • An Eastern Cooperative Oncology Group performance status of 0 or 1

You may not qualify if:

  • \. Prior treatment with:
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Affiliated Cancer Hospital of Guangzhou Medical University

Guangzhou, China

Location

Meizhou People's Hospital

Meizhou, China

Location

Related Publications (3)

  • Kamiya N, Suzuki H, Ueda T, Sato N, Nakatsu H, Mikami K, Sato N, Nomura K, Akakura K, Okano T, Ooki T, Naya Y, Ota S, Masai M, Ichikawa T. Clinical outcomes by relative docetaxel dose and dose intensity as chemotherapy for Japanese patients with castration-resistant prostate cancer: a retrospective multi-institutional collaborative study. Int J Clin Oncol. 2014 Feb;19(1):157-64. doi: 10.1007/s10147-012-0510-9. Epub 2013 Jan 9.

    PMID: 23299278RESULT

  • Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED, Kopyltsov E, Park CH, Alekseev B, Montesa-Pino A, Ye D, Parnis F, Cruz F, Tammela TLJ, Suzuki H, Utriainen T, Fu C, Uemura M, Mendez-Vidal MJ, Maughan BL, Joensuu H, Thiele S, Li R, Kuss I, Tombal B; ARASENS Trial Investigators. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022 Mar 24;386(12):1132-1142. doi: 10.1056/NEJMoa2119115. Epub 2022 Feb 17.

    PMID: 35179323RESULT

  • Jimenez N, Garcia de Herreros M, Reig O, Marin-Aguilera M, Aversa C, Ferrer-Mileo L, Garcia-Esteve S, Rodriguez-Carunchio L, Trias I, Font A, Rodriguez-Vida A, Climent MA, Cros S, Chirivella I, Domenech M, Figols M, Carles J, Suarez C, Herrero Rivera D, Gonzalez-Billalabeitia E, Civico C, Sala-Gonzalez N, Ruiz de Porras V, Ribal MJ, Prat A, Mellado B. Development and Independent Validation of a Prognostic Gene Expression Signature Based on RB1, PTEN, and TP53 in Metastatic Hormone-sensitive Prostate Cancer Patients. Eur Urol Oncol. 2024 Aug;7(4):954-964. doi: 10.1016/j.euo.2023.12.012. Epub 2024 Mar 1.

    PMID: 38429210RESULT

MeSH Terms

Interventions

darolutamideDocetaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Central Study Contacts

yonghong Li

CONTACT

13711376697liyongh@sysucc.org.cn

zhenyu yang

CONTACT

yangzy@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy Director of the Department of Urology

Study Record Dates

First Submitted

March 25, 2026

First Posted

March 31, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

CN(2)