Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer

NCT06575257 | Recruiting Phase 2

• 1 other identifier: KY20242118-C-1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if treatment with Darolutamide plus androgen deprivation therapy (ADT) before radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and pathological tumor volume with minimal residual disease (MRD)) as compared to ADT.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Pathologic Complete Response Rate

  The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy

  After 12 weeks of neoadjuvant therapy + RP + PLND

• Proportion of Subjects With Minimal Residual Disease

  The proportion of subjects that have residual tumors with maximum diameter of 5 mm or less after radical prostatectomy

  After 12 weeks of neoadjuvant therapy + RP + PLND

Secondary Outcomes (8)

• Rate of Stage Degradation

  After 12 weeks of neoadjuvant therapy + RP + PLND

• Rate of Positive Surgical Margins

  After 12 weeks of neoadjuvant therapy + RP + PLND

• Rate of Complete Serum Remission

  After 12 weeks of neoadjuvant therapy

• Proportion of subjects without PSA progression

  2 years after RP

• Imaging Response Rate

  After 12 weeks of neoadjuvant therapy

Study Arms (2)

Darolutamide Plus ADT

EXPERIMENTAL

All participants in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus Darolutamide. Goserelin 3.6 mg will be used once per 4 weeks. Darolutamide will be administered orally as 600 mg twice a day. Subjects will continue to take Darolutamide Plus Goserelin for 12 weeks before radical prostatectomy

Drug: Darolutamide; Drug: Goserelin 3.6 mg

ADT alone

EXPERIMENTAL

All participants in this arm will receive LHRHa alone for 12 weeks before receiving radical prostatectomy. Goserelin 3.6 mg will be administered once per 4 weeks.

Drug: Goserelin 3.6 mg

Interventions

Darolutamide DRUG

600 mg orally twice daily for 12 weeks before radical prostatectomy

Darolutamide Plus ADT

Goserelin 3.6 mg DRUG

3.6 mg goserelin hypodermic once per 4 weeks

ADT alone; Darolutamide Plus ADT

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 and must be eligible for radical prostatectomy.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤1.
• All patients must complete mpMRI or 68Ga-PSMA PET / CT before and after neoadjuvant treatment.
• All patients must undergo thorough tumor staging and meet one of the following criteria: 1. multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ cT2c or cN+or locally advanced, 2. Gleason score of primary tumor ≥ 8, 3. prostate specific antigen (PSA) ≥20 ng/ml.
• Patients must have adequate organ function as defined by the following criteria(within 28 days prior to registration):
• white blood cell (WBC) ≥ 4.0 × 109 / L platelets≥ 100 × 109 / L hemoglobin ≥ 9 g / dL international normalized ratio (INR) \< 1.5. total bilirubin (TBIL)≤1.5 x upper limit of normal (ULN) SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN serum creatinine ≤2×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.

You may not qualify if:

• clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases.
• Prior androgen deprivation therapy (medical or surgical) or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy.
• severe or uncontrolled concurrent infections.
• New York Heart Association Class III or IV congestive heart failure at the time of screening.
• uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
• Patients with mental illness, mental disability or inability to give informed consent are not eligible.
• Patients 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

The First Affillated Hospital, the Air Force Medical University

Xi’an, Shanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

darolutamide; Goserelin

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)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Weijun Qin, MD

  The First Affillated Hospital, the Air Force Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weijun Qin, MD

CONTACT

029-84771579; qinwj@fmmu.edu.cn

Jingliang Zhang, MD

CONTACT

zhangjingliang@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2029
• Last Updated: August 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)