Neoadjuvant Therapy With Proxalutamide Combined With Andr... | NCT05076851

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

NCT05076851

Sponsor

Hongqian Guo

Status

Unknown status

Last Update Posted

Oct 13, 2021Actual

Enrollment

2Estimated

Phase

Phase 2

Conditions

Neoadjuvant Therapy \High Risk Prostate Cancer

Interventions

placebo
Proxalutamide

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 17, 2021Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Oct 31, 2022Estimated

First Submitted Date

Jun 22, 2021

First Submission Date that Met QC Criteria

Oct 12, 2021

First Posted Date

Oct 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2021

Last Update Posted Date

Oct 13, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hongqian Guo, chief physician, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolSponsor-Investigator

Lead Sponsor

Hongqian GuoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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,

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo group	Placebo Comparator	placebo+ADT	Other: placebo
Proxalutamide	Experimental	Proxalutamide +ADT	Drug: Proxalutamide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
placebo	Other	placebo+ADT（Androgen Deprivation Therapy），Route of placebo administration: tablet, dosage：300mg , dosage form oral , frequency of administration：QD	placebo group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pathologic Complete Response Rate	The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy	up to 6months
Proportion of Subjects With Minimal Residual Disease	The proportion of subjects that have residual tumors with maximum diameter of 3 mm or less after radical prostatectomy	up to 6months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study
Patients must be ≥ 18，male
Histopathological by Prostate biopsy confirmed prostatic cancer（No Neuroendocrine prostate cancer or small cell carcinoma）
High-risk prostate cancer (T2c≤ clinical stage ≤T4 or Gleason score ≥8 or PSA≥20ng/ml)
Patients willing to undergo laparoscopic radical resection of prostate cancer and extensive lymph node dissection
ECOG PS：0-1

Exclusion Criteria:

Imaging or biopsy confirmed distant Metastatic lesion
The number of regional lymph nodes metastasis >3
Patients had undergone The treatment of Systemic chemotherapy and endocrine therapy for prostate cancer
Patients had undergone prostate surgery、radical radiotherapy or Bilateral orchidectomy

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hongqian Guo, Phd	Contact	+86-13605171690		dr.ghq@nju.edu.cn
Shun Zhang, Phd	Contact	+86-15050589789		explorershun@126.com

Overall Officials

Name	Affiliation	Role
Hongqian Guo, Phd	Study Chair Department of Urology, Drum Tower Hospital, Medical School of Nanjing University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Affiliated Hospital of Nanjing University Medical School	Recruiting	Nanjing	Jiangsu	210008	China

Intervention Browse Module

MeSH Terms

ID	Term
C000599887	proxalutamide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided