A Trial of SHR3680 in Prostate Cancer Patients Who Are Candidates for Radical Prostatectomy

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

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).

Study Overview

• Status: Recruiting
• Conditions: Patients With High-risk Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
• Intervention / Treatment: Drug: SHR3680; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 1256
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Chunlei Jin, M.D.; Phone Number: +86-18036618079; Email: chunlei.jin@hengrui.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Age of ≥ 18 years old;
2. ECOG PS score of 0 or 1;
3. Pathologically diagnosed as prostate adenocarcinoma;
4. High-risk patients
5. No distant metastasis (clinical staging of M0) as determined by BICR of imaging examinations;
6. Subjects who are candidates for and plan to undergo radical prostatectomy (removal of the entire prostate and seminal vesicle plus pelvic lymphadenectomy);

Exclusion Criteria:

1. 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;
2. Subjects who received any other investigational products or underwent major surgery within 4 weeks prior to randomization;
3. Subjects who are planning bilateral orchidectomy during the treatment period of the study;
4. Subjects with dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption;
5. 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);
6. 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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment group：SHR3680 + ADT	Drug: SHR3680; 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.
PLACEBO_COMPARATOR: Treatment group : Placebo + ADT	Drug: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	36 months since the first subject will be enrolled.
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.	84 months since the first subject will be enrolled.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	84 months since the first subject will be enrolled.
PSA response rate.	Defined as the proportion of subjects with a ≥ 90% decrease in PSA levels from baseline on Day 1 of Cycle 4.	25 months since the first subject will be enrolled.
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.	31 months since the first subject will be enrolled.
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).	42 months since the first subject will be enrolled.

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2021
• Primary Completion (ANTICIPATED): October 30, 2027
• Study Completion (ANTICIPATED): October 30, 2031

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 15, 2021
• First Posted (ACTUAL): August 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: SHR3680-III-302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No