Patients With High-risk Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical ProstatectomyPhase 3NCT05009290

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

A Phase 3 study testing SHR3680 in people with Patients With High-risk Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Patients With High-risk Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
What is being tested?: SHR3680
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 391 participants
Where: 1 siteChina
Study dates: 1 Nov 2021to 6 Sep 2024
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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);

Who cannot join

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;

Trial locations and contacts

1 site in 1 country.

China1 site

Fudan University Shanghai Cancer center
Shanghai, Shanghai Municipality

Other trials in China

About this study

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

Conditions: Patients With High-risk Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
Being tested: SHR3680, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SHR3680Drug
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.
PlaceboDrug
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.

Study groups in NCT05009290
Study group	Role	What they receive
Treatment group：SHR3680 + ADT	Experimental	Not described Receives: Drug: SHR3680
Treatment group : Placebo + ADT	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 84 months since the first subject will be enrolled.

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 42 months since the first subject will be enrolled.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20216 Sep 2024

First posted17 Aug 2021
Study start1 Nov 2021
Primary completion6 Sep 2024
Study completion6 Sep 2024

Why it stopped: Due to the adjustment of the sponsor's development plan, after discussion with leading PI, sponsor has decided to terminate this study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Patients With High-risk Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical ProstatectomyStudies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: SHR3680 + ADT compared with placebo + ADT
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 391 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05009290
Sponsor's protocol ID: SHR3680-III-302
Status last verified: Sep 2025
First submitted: 9 Aug 2021
Last updated: 3 Apr 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05009290
Acronym / sponsor ID: SHR3680-III-302
Conditions: Patients With High-risk Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to the adjustment of the sponsor's development plan, after discussion with leading PI, sponsor has decided to terminate this study.
Enrolment: 391 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 1 Nov 2021 (actual)
Primary completion: 6 Sep 2024 (actual)
Study completion: 6 Sep 2024 (actual)
First posted: 17 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: SHR3680 + ADT compared with placebo + ADT

Arm	Type	Receives
Treatment group：SHR3680 + ADT	Experimental	Drug: SHR3680
Treatment group : Placebo + ADT	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (6 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SHR3680Treatment 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.	Drug	Treatment group：SHR3680 + ADT
PlaceboTreatment 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.	Drug	Treatment group : Placebo + ADT

Primary outcome

pCR rate (assessed by pathology BICR)
Time frame: 36 months since the first subject will be enrolled.
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).
Time frame: 84 months since the first subject will be enrolled.
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.

4 secondary outcomes

MFS (investigator-assessed).
Time frame: 84 months since the first subject will be enrolled.
PSA response rate.
Time frame: 25 months since the first subject will be enrolled.
PSM rate.
Time frame: 31 months since the first subject will be enrolled.
Time to BCR.
Time frame: 42 months since the first subject will be enrolled.

Results and safety

The study was stopped early (reason given: Due to the adjustment of the sponsor's development plan, after discussion with leading PI, sponsor has decided to terminate this study.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pCR rate (assessed by pathology BICR) (time frame: 36 months since the first subject will be enrolled.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05009290.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.