Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to the adjustment of the sponsor's development plan, after discussion with leading PI, sponsor has decided to terminate this study.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patients With High-risk Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| SHR3680 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment group:SHR3680 + ADT
- interventionNames
- Drug: SHR3680
- type
- PLACEBO_COMPARATOR
- label
- Treatment group : Placebo + ADT
- interventionNames
- Drug: Placebo
Primary outcomes (2)
- measure
- pCR rate (assessed by pathology BICR)
- timeFrame
- 36 months since the first subject will be enrolled.
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available