Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy(ADT)for High Risk Prostate Cancer

Sponsor
Hongqian Guo (Other)
Overall Status
Recruiting
CT.gov ID
NCT05076851
Collaborator
(none)
2
Enrollment
1
Location
2
Arms
16.5
Anticipated Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Proxalutamide combined with androgen deprivation therapy(ADT)for High risk prostate cancer ,This trial is A randomized, controlled, double-blind, single center.Treatment cycle is 6 months,

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Proxalutamide: androgen deprivation therapy(ADT)=2:1Proxalutamide: androgen deprivation therapy(ADT)=2:1
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Randomized, Controlled, Double-blind, Single Center,Clinical Trial to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy(ADT)for High Risk Prostate Cancer
Actual Study Start Date :
Jun 17, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

ArmIntervention/Treatment
Placebo Comparator: placebo group

placebo+ADT

Other: placebo
placebo+ADT(Androgen Deprivation Therapy) ,Route of placebo administration: tablet, dosage:300mg , dosage form oral , frequency of administration:QD

Experimental: Proxalutamide

Proxalutamide +ADT

Drug: Proxalutamide
Proxalutamide +ADT(Androgen Deprivation Therapy) ,Route of Proxalutamide administration: tablet, dosage:300mg , dosage form oral , frequency of administration:QD

Outcome Measures

Primary Outcome Measures

  1. Pathologic Complete Response Rate [up to 6months]

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

  2. Proportion of Subjects With Minimal Residual Disease [up to 6months]

    The proportion of subjects that have residual tumors with maximum diameter of 3 mm or less after radical prostatectomy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study

  2. Patients must be ≥ 18,male

  3. Histopathological by Prostate biopsy confirmed prostatic cancer(No Neuroendocrine prostate cancer or small cell carcinoma)

  4. High-risk prostate cancer (T2c≤ clinical stage ≤T4 or Gleason score ≥8 or PSA≥20ng/ml)

  5. Patients willing to undergo laparoscopic radical resection of prostate cancer and extensive lymph node dissection

  6. ECOG PS:0-1

Exclusion Criteria:
  1. Imaging or biopsy confirmed distant Metastatic lesion

  2. The number of regional lymph nodes metastasis >3

  3. Patients had undergone The treatment of Systemic chemotherapy and endocrine therapy for prostate cancer

  4. Patients had undergone prostate surgery、radical radiotherapy or Bilateral orchidectomy

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1The Affiliated Hospital of Nanjing University Medical SchoolNanjingJiangsuChina210008

Sponsors and Collaborators

  • Hongqian Guo

Investigators

  • Study Chair: Hongqian Guo, Phd, Study Chair Department of Urology, Drum Tower Hospital, Medical School of Nanjing University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hongqian Guo, chief physician, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier:
NCT05076851
Other Study ID Numbers:
  • IIT-GT0918-CN-1008
First Posted:
Oct 13, 2021
Last Update Posted:
Oct 13, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2021