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

NCT05009290 | Recruiting Phase 3

• 1 other identifier: SHR3680-III-302
• Study Type: interventional
• Target: 1,256
• Locations: 1 country
• Sites: 1

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).

Conditions

Patients With High-risk Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• MFS (investigator-assessed).

  84 months since the first subject will be enrolled.

• PSA response rate.

  25 months since the first subject will be enrolled.

• PSM rate.

  31 months since the first subject will be enrolled.

• Time to BCR.

  42 months since the first subject will be enrolled.

Study Arms (2)

Treatment group：SHR3680 + ADT

EXPERIMENTAL

Drug: SHR3680

Treatment group : Placebo + ADT

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SHR3680 DRUG

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.

Treatment group：SHR3680 + ADT

Placebo DRUG

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.

Treatment group : Placebo + ADT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer center

Shanghai, Shanghai Municipality, China

RECRUITING

Central Study Contacts

Chunlei Jin, M.D.

CONTACT

+86-18036618079; chunlei.jin@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR3680 + ADT compared with placebo + ADT

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 17, 2021
• Study Start: November 1, 2021
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2031
• Last Updated: January 13, 2022

Record last verified: 2021-08

Locations

CN (1)