Efficacy and Safety of Darolutamide Combined With ADT in High-risk/Very High-risk Localized Prostate Cancer

NCT05249712 | Unknown Phase 2

• 1 other identifier: IUNU-PC-112
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Darolutamide combined with Androgen-Deprivation Therapy in High-risk/Very high-risk localized prostate cancer. This trial is A prospective, single-arm, multicenter clinical trial. Treatment cycle is 24 weeks,

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological Response Rate （pCR or MRD）

  Pathological Response Rate is defined as the pCR(Pathologic Complete Response Rate) or MRD (Proportion of Subjects With Minimal Residual Disease) Pathologic Complete Response Rate is defined as the proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy. Proportion of Subjects With Minimal Residual Disease is defined as the proportion of subjects that have residual tumors with maximum diameter of 5 mm or less after radical prostatectomy or residual cancer burden \<0.25cm3.

  up to 8months

Secondary Outcomes (5)

• AEs/SAEs

  Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first

• PSA biochemical progression-free survival rate

  3 years

• Rate of Positive Surgical Margins

  up to 8 months

• Rate of Stage Degradation

  up to 8 months

• PSA response rate

  up to 2 years

Other Outcomes (3)

• Change From Baseline in Quality of Life as assessed by FACT-P

  up to 2 years

• Change From Baseline in Quality of life as assessed by BPI-SF

  up to 2 years

• Change From Baseline in Quality of life as assessed by EPIC-26

  up to 2 years

Study Arms (1)

ADT with Darolutamide

EXPERIMENTAL

Pathological response rate after radical prostatectomy with dalotamide combined with androgen deprivation therapy (ADT) in neoadjuvant therapy for surgically resectable high-risk or very high-risk prostate cancer. Duration of treatment: 28-day cycle of darotamide treatment and 6 cycles of neoadjuvant therapy. ADT treatment continued during neoadjuvant therapy and was discontinued after surgery. Adjusted dosing: When the serum testosterone concentration cannot be maintained at \<50 ng/dL, the dose and type of ADT can be adjusted. Investigators can adjust the dose of darostatide according to the situation.

Drug: Darolutamide 300 mg; Other: Androgen deprivation therapy

Interventions

Darolutamide 300 mg DRUG

600 mg (300 mg × 2 tablets) twice daily with meals, equivalent to a total daily dose of 1200 mg.

Also known as: Nubeqa, BAY1841788

ADT with Darolutamide

Androgen deprivation therapy OTHER

The ADT regimen used by each patient will be determined by the investigator, and the dose and frequency of administration will be consistent with the prescribing information.

Also known as: ADT

ADT with Darolutamide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be ≥ 18 and ≤75 years of age；
• All patients must have a histologically or cytologically diagnosis of prostate cancer，without distant metastasis, and suitable for radical prostatectomy；
• All patients meet at least one of the following criteria：
• multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ T3；
• Gleason score of primary tumor ≥ 8；
• prostate specific antigen (PSA) ≥20 ng/ml； d) Radiographic assessment of regional lymph node metastases (N1)；
• Eastern Cooperative Oncology Group (ECOG) physical condition score 0- 1；
• Patients must have adequate organ function： hematologic function：within 28 days prior to registration as evidenced by: white blood cell (WBC) ≥ 4.0 × 109 / L, platelets≥ 100 × 109 / L, hemoglobin ≥ 9 g / dL and international normalized ratio (INR) \< 1.5； renal function：within 28 days prior to registration, as evidenced by serum creatinine ≤2×ULN； hepatic function: within 28 days prior to registration, as evidenced by: total bilirubin (TBIL)≤1.5 x upper limit of normal (ULN),and SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN；
• Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must be willing to obey the prohibitions and restrictions specified in the research protocol.
• Patients of childbearing potential must be willing to take high-efficiency contraceptive measures during the study period and within 120 days after the last dose of treatment.

You may not qualify if:

• Patients with prostate having neuroendocrine, small cell, or sarcoma-like features are not eligible.
• Patients with low-risk and medium-risk, localized prostate cancer (the following conditions are met at the same time) are not eligible: multiparameter MRI or PSMA PET / CT shows clinical staging of primary tumor \< T3, Gleason score of primary tumor \< 8, and prostate specific antigen (PSA)。
• Patients with clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases are not eligible.（any M1）。
• Patients who have previously received androgen deprivation therapy (medical or surgical) more than 3 months or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy are not eligible
• Patients with severe or uncontrolled concurrent infections are not eligible。
• Patients must not have New York Heart Association Class III or IV congestive heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months prior to registration.
• Patients must not have uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
• Patients must not have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.
• The patient is mentally ill, mentally disabled or incapable of giving informed consent

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead
• First Affiliated Hospital of Zhejiang University: collaborator
• The First Affiliated Hospital of Soochow University: collaborator

Study Sites (1)

Hongqian Guo

Nanning, Jiangsu, China

RECRUITING

Related Publications (1)

• Zhang X, Zhou F, Lu T, Zhang S, Wei X, Qiu X, Xu L, Guo H, Zhuang J. Neoadjuvant darolutamide plus androgen deprivation therapy for high-risk and locally advanced prostate cancer: a multicenter, open-label, single-arm, phase II trial. World J Urol. 2025 Jan 3;43(1):58. doi: 10.1007/s00345-024-05412-4.

  PMID: 39751962 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

darolutamide; Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Hongqian Guo, Phd

  Nanjing Drum Tower Hospital, affiliated to medical school of Nanjing University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongqian Guo, Phd

CONTACT

+86-13605171690; dr.ghq@nju.edu.cn

Shun Zhang, Phd

CONTACT

+86-15050589789; explorershun@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 22, 2022
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: December 1, 2025
• Last Updated: January 3, 2023

Record last verified: 2022-12

Locations

CN (1)