NCT06029036

Brief Summary

Scientific Rationale: High risk localized prostate cancer (PCa) is associated with higher rates of biochemical recurrence, clinical recurrence, metastasis and PCa-specific death. Novel hormone therapies(NHT) have shown a significant survival advantage with respect to classical ADT in later stages of PCa and have already been investigated in neoadjuvant setting. PURPOSE: To assess antitumor effect by measuring pathological tumor volume with pathological downstaging following radical prostatectomy + pelvic lymph-node dissection (RP + PLND) for high-risk localized prostate cancer patients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
2mo left

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
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 Progress94%
Aug 2023Jul 2026

Study Start

First participant enrolled

August 5, 2023

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

December 12, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

September 1, 2023

Last Update Submit

December 5, 2023

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Rate of pathological downstaging

    Percentage of patients with tumor downstaging

    6 months

Secondary Outcomes (7)

  • pCR or MRD

    6 months

  • PSM

    6 months

  • Rate of peri-operative complications

    within 30 days of surgery

  • Biochemical complete response

    6 months

  • PSA undetectable rate

    12 months post-RP

  • +2 more secondary outcomes

Study Arms (1)

Darolutamide + ADT

EXPERIMENTAL

Duration of treatment: 28-day cycle of darolutamide treatment and 6 cycles of neoadjuvant therapy.

Drug: Darolutamide+ADT

Interventions

Darolutamide+ADTDRUG

Drug: Darolutamide Darolutamide 600 mg, (two 300 mg tablets) administered orally twice daily. Swallow tablets whole. Take Darolutamide with food. Drug: ADT GnRH agonist per physicians' choice, orchiectomy is excluded

Darolutamide + ADT

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male ≥18 years of age.
  • Able to Sign informed consent form independently.
  • Non-metastatic adenocarcinoma of the prostate.
  • Subjects must have as least one of the following features according to NCCN definition of high-risk: Gleason score ≥8, or PSA \>20ng/ml,or≥clinical T3a.
  • Subjects with pelvic lymph node involvement(N1) can be included.
  • Candidate for radical prostatectomy with or without pelvic lymph node dissection as per the investigator.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Subjects must have normal organ and marrow function as defined below:
  • Hemoglobin ≥ 9.0 g/dL;Absolute neutrophil count (ANC) ≥ 1,500/mcL; Platelets ≥ 100,000/mcL, independent of transfusions/growth factors within 3 months of treatment start; Serum potassium ≥ 3.5 mmol/L; Serum total bilirubin ≤ 2.0 x upper limit of normal (ULN) (except in subjects with Gilbert's syndrome who have a total bilirubin \> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible);Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN;Serum albumin ≥ 3.0 g/dL;Serum creatinine \< 2.0 x ULN.

You may not qualify if:

  • Prostate cancer with neuroendocrine differentiation or small cell features
  • History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer.
  • Subjects who are planning bilateral orchidectomy during the treatment period of the study.
  • Intolerable with darolutamide or ADT treatment.
  • Candidates of other clinical trials.
  • Any prior malignancy within 5 years.
  • Complications include significant cardiovascular disease, active infection, astrointestinal disorders, or any other complications that in the opinion of the investigator.
  • Any condition that in the opinion of the investigator would preclude participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Zhisong He, MD

CONTACT

+8610-83572418wyj7074@sohu.com

Kaiwei Yang, MD

CONTACT

1381150143513811501435@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2023

First Posted

September 8, 2023

Study Start

August 5, 2023

Primary Completion

July 31, 2025

Study Completion (Estimated)

July 31, 2026

Last Updated

December 12, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)