Back to resultsA Trial of SHR3680 in Prostate Cancer Patients Who Are Candidates for Radical Prostatectomy
Primary Purpose
Patients With High-risk Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SHR3680
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Patients With High-risk Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
Eligibility Criteria
Inclusion Criteria:
- Age of ≥ 18 years old;
- ECOG PS score of 0 or 1;
- Pathologically diagnosed as prostate adenocarcinoma;
- High-risk patients
- No distant metastasis (clinical staging of M0) as determined by BICR of imaging examinations;
- Subjects who are candidates for and plan to undergo radical prostatectomy (removal of the entire prostate and seminal vesicle plus pelvic lymphadenectomy);
Exclusion Criteria:
- Subjects who received any prior treatment for prostate cancer, except medical ADT and/or first-generation androgen receptor antagonists (such as bicalutamide) for not more than 4 weeks;
- Subjects who received any other investigational products or underwent major surgery within 4 weeks prior to randomization;
- Subjects who are planning bilateral orchidectomy during the treatment period of the study;
- Subjects with dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption;
- Subjects with a history of epilepsy, or diseases that can induce seizures occurred within 12 months prior to randomization (including a history of transient ischemic attack, stroke, traumatic brain injury, and cognitive impairment, requiring hospitalization);
- Subjects with active heart disease within 6 months prior to randomization, including: severe/unstable angina pectoris, myocardial infarction, symptomatic congestive heart failure, and ventricular arrhythmias requiring medical treatment;
Sites / Locations
- Fudan University Shanghai Cancer centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment group：SHR3680 + ADT
Treatment group : Placebo + ADT
Arm Description
Outcomes
Primary Outcome Measures
pCR rate (assessed by pathology BICR)
Defined as the proportion of subjects with no residual tumor detected in prostatectomy specimens by H&E staining and ancillary immunohistochemistry (if necessary) as assessed by pathology BICR.
MFS (assessed by imaging BICR).
Defined as the time from the date of randomization to the date of first occurrence of BICR-confirmed radiographic distant metastasis, accidental pathologic finding of distant metastasis, or death from any cause (whichever occurs first), regardless of whether the subject reveives any other anti-tumor therapy or has missing (or unevaluable) tumor assessments.
Secondary Outcome Measures
MFS (investigator-assessed).
Defined as the time from the date of randomization to the date of first occurrence of investigator-assessed radiographic distant metastasis to the bone or soft tissue, accidental pathologic finding of distant metastasis, or death from any cause (whichever occurs first), regardless of subsequent anti-tumor treatment or missing (or unevaluable) tumor assessments.
PSA response rate.
Defined as the proportion of subjects with a ≥ 90% decrease in PSA levels from baseline on Day 1 of Cycle 4.
PSM rate.
Defined as the proportion of subjects without tumor cells detected in the margin of prostatectomy pathological specimens following H&E staining and ancillary immunohistochemistry (if necessary), as assessed by local pathologists.
Time to BCR.
Defined as the time from the date of randomization to the time of BCR (i.e. two consecutive PSA rise ≥ 0.2 ng/mL following radical prostatectomy).
Full Information
NCT ID
NCT05009290
First Posted
August 9, 2021
Last Updated
December 28, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05009290
Brief Title
A Trial of SHR3680 in Prostate Cancer Patients Who Are Candidates for Radical Prostatectomy
Official Title
A Phase III Randomized, Placebo-Controlled, Double-Blind Study of SHR3680 Plus Androgen Deprivation Therapy (ADT) Versus ADT in Patients With High-Risk Localized or Locally Advanced Prostate Cancer Undergoing Radical Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
October 30, 2027 (Anticipated)
Study Completion Date
October 30, 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study is being conducted to evaluate the efficacy and safety of SHR3680 plus androgen deprivation therapy (ADT) vs. placebo plus ADT in patients with high-risk localized or locally advanced prostate cancer using pathologic complete response (pCR) rate and metastasis-free survival (MFS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With High-risk Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
SHR3680 + ADT compared with placebo + ADT
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1256 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group：SHR3680 + ADT
Arm Type
Experimental
Arm Title
Treatment group : Placebo + ADT
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SHR3680
Intervention Description
Treatment group: SHR3680 240 mg orally once daily before or after breakfast, 28 days per cycle for a total of 12 treatment cycles (6 cycles before and 6 cycles following radical prostatectomy).
Goserelin acetate sustained-release depot: 10.8 mg administered subcutaneously into the anterior abdominal wall once every 3 cycles (12 weeks) for a total of 12 cycles.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Treatment group ：Placebo 240 mg orally once daily before or after breakfast, 28 days per cycle for a total of 12 treatment cycles (6 cycles before and 6 cycles following radical prostatectomy).
Goserelin acetate sustained-release depot: 10.8 mg administered subcutaneously into the anterior abdominal wall once every 3 cycles (12 weeks) for a total of 12 cycles.
Primary Outcome Measure Information:
Title
pCR rate (assessed by pathology BICR)
Description
Defined as the proportion of subjects with no residual tumor detected in prostatectomy specimens by H&E staining and ancillary immunohistochemistry (if necessary) as assessed by pathology BICR.
Time Frame
36 months since the first subject will be enrolled.
Title
MFS (assessed by imaging BICR).
Description
Defined as the time from the date of randomization to the date of first occurrence of BICR-confirmed radiographic distant metastasis, accidental pathologic finding of distant metastasis, or death from any cause (whichever occurs first), regardless of whether the subject reveives any other anti-tumor therapy or has missing (or unevaluable) tumor assessments.
Time Frame
84 months since the first subject will be enrolled.
Secondary Outcome Measure Information:
Title
MFS (investigator-assessed).
Description
Defined as the time from the date of randomization to the date of first occurrence of investigator-assessed radiographic distant metastasis to the bone or soft tissue, accidental pathologic finding of distant metastasis, or death from any cause (whichever occurs first), regardless of subsequent anti-tumor treatment or missing (or unevaluable) tumor assessments.
Time Frame
84 months since the first subject will be enrolled.
Title
PSA response rate.
Description
Defined as the proportion of subjects with a ≥ 90% decrease in PSA levels from baseline on Day 1 of Cycle 4.
Time Frame
25 months since the first subject will be enrolled.
Title
PSM rate.
Description
Defined as the proportion of subjects without tumor cells detected in the margin of prostatectomy pathological specimens following H&E staining and ancillary immunohistochemistry (if necessary), as assessed by local pathologists.
Time Frame
31 months since the first subject will be enrolled.
Title
Time to BCR.
Description
Defined as the time from the date of randomization to the time of BCR (i.e. two consecutive PSA rise ≥ 0.2 ng/mL following radical prostatectomy).
Time Frame
42 months since the first subject will be enrolled.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age of ≥ 18 years old;
ECOG PS score of 0 or 1;
Pathologically diagnosed as prostate adenocarcinoma;
High-risk patients
No distant metastasis (clinical staging of M0) as determined by BICR of imaging examinations;
Subjects who are candidates for and plan to undergo radical prostatectomy (removal of the entire prostate and seminal vesicle plus pelvic lymphadenectomy);
Exclusion Criteria:
Subjects who received any prior treatment for prostate cancer, except medical ADT and/or first-generation androgen receptor antagonists (such as bicalutamide) for not more than 4 weeks;
Subjects who received any other investigational products or underwent major surgery within 4 weeks prior to randomization;
Subjects who are planning bilateral orchidectomy during the treatment period of the study;
Subjects with dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption;
Subjects with a history of epilepsy, or diseases that can induce seizures occurred within 12 months prior to randomization (including a history of transient ischemic attack, stroke, traumatic brain injury, and cognitive impairment, requiring hospitalization);
Subjects with active heart disease within 6 months prior to randomization, including: severe/unstable angina pectoris, myocardial infarction, symptomatic congestive heart failure, and ventricular arrhythmias requiring medical treatment;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunlei Jin, M.D.
Phone
+86-18036618079
Email
chunlei.jin@hengrui.com
Facility Information:
Facility Name
Fudan University Shanghai Cancer center
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dingwei Ye
12. IPD Sharing Statement
Learn more about this trial
A Trial of SHR3680 in Prostate Cancer Patients Who Are Candidates for Radical Prostatectomy
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