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Prostate CancerPhase 2SHARPNCT07451795

SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC

A Phase 2 study testing SHR-1701 + SBRT and SBRT in people with Prostate Cancer and mCRPC (Metastatic Castration-resistant Prostate Cancer), run by Fudan University at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of this study is to evaluate the efficacy of SHR-1701 in combination with SBRT in patients with metastatic castration-resistant prostate cancer. Dr. Yao Zhu from Fudan University Shanghai Cancer Center is the co-leading PI of this study. Read more about this study

Who is it for?
Ages 18 to 80 years, men only
What is being tested?
SHR-1701 + SBRT and SBRT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
3 sitesChina
Study dates
2 Mar 2026to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18 to 80 years old.
  • Diagnosis: Histologically or cytologically confirmed adenocarcinoma of the prostate, clinically staged as metastatic prostate cancer based on conventional imaging (bone scan or CT/MRI).
  • Biopsy: Whenever possible, patients should undergo a pre-treatment image-guided biopsy of a lesion; alternatively, archived biopsy tissue obtained within 30 days prior to enrollment is acceptable.
  • Prior Therapy: Failure of at least one prior next-generation hormone therapy (NHT), such as abiraterone acetate, rezivilutamide, enzalutamide, apalutamide, or darolutamide.
  • Chemotherapy History: Prior treatment with docetaxel, or documentation of intolerance to or refusal of chemotherapy.
  • Disease Progression: Evidence of disease progression defined by: PSA progression: At least two consecutive increases in PSA levels, measured at least 1 week apart, with a screening PSA value ≥ 1 ng/mL; OR Radiographic progression in soft tissue per RECIST v1.1 (with or without PSA progression); OR Bone progression per PCWG3 criteria (occurrence of ≥ 2 new bone lesions on bone scan).
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  • Castration Status: Maintenance of effective and continuous luteinizing hormone-releasing hormone analog (LHRHa) therapy throughout the study period, or prior bilateral orchidectomy; serum testosterone must be maintained at castrate levels (< 50 ng/dL).
  • Performance Status: ECOG Performance Status score of 0 to 2.
  • Life Expectancy: ≥ 6 months.
  • Hematologic Function: Absolute neutrophil count (ANC) ≥ 1.5 ×10^9/L; Platelets ≥ 75 ×10^9/L; Hemoglobin ≥ 90 g/L; White blood cell (WBC) count ≥ 3.0 ×10^9/L.
  • Hepatic Function (Transaminases): Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN); for patients with liver metastases, ALT/AST ≤ 5 × ULN.
  • Hepatic Function (Bilirubin): Total bilirubin ≤ 1.5 × ULN, or total bilirubin > 1.5
  • × ULN if direct bilirubin ≤ ULN.
  • Coagulation Function: INR ≤ 1.5, Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, and Prothrombin time (PT) < ULN + 4 seconds.
  • Cardiac Function: Left ventricular ejection fraction (LVEF) ≥ 50%; QTc < 450 ms for males; serum potassium ≥ 3.5 mmol/L.
  • Blood Pressure: Systolic BP < 160 mmHg and diastolic BP < 95 mmHg; patients with stable BP after appropriate clinical management are eligible.
  • Renal Function: Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min.
  • Contraception: Sexually active patients with ejaculatory potential must agree to use effective contraception and refrain from sperm donation from the first dose until 3 months after the last dose of study treatment.
  • Informed Consent: Ability to understand and willingness to sign a written Informed Consent Form (ICF).
  • Compliance: Ability to comply with the study visit schedule and other protocol requirements.

Who cannot join

  • Concurrent Therapy: Plan to receive any other anti-tumor therapy during the study treatment period.
  • Brain Metastasis: Presence of brain metastases.
  • Prior Immunotherapy: Previous treatment with immune checkpoint inhibitors (including PD-1, PD-L1, CTLA-4 inhibitors, etc.) or any anti-tumor agents targeting T-cells or activating the immune system.
  • Other Malignancies: Known other malignancies that are progressing or require active treatment within the past 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy.
  • Autoimmune Disease/Infection: Active autoimmune disease or active infection (including tuberculosis) requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal/pituitary insufficiency) is not considered systemic treatment.
  • Immunosuppression: Diagnosis of immunodeficiency or receipt of chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose.
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  • Pneumonitis: History of (non-infectious) pneumonitis requiring steroid treatment or current non-infectious pneumonitis.
  • Prior Radiation/Hormonal Washout: Receipt of radiotherapy or radionuclide therapy (e.g., Radium-223) within 28 days prior to the first dose; or abiraterone within 1 week, or other anti-androgen therapy within 2 weeks prior to the first dose.
  • Hypersensitivity: Hypersensitivity or intolerance to the active ingredients or any excipients of the PD-L1 monoclonal antibody.
  • Neuropsychiatric Disorders: Known history of significant neurological or psychiatric disorders, such as dementia, epilepsy, or seizure-prone conditions.
  • Concomitant Conditions: Any concurrent medical condition (e.g., severe diabetes, thyroid disease, or psychiatric illness) that, in the investigator's judgment, poses a severe risk to subject safety or interferes with study completion; or any unstable medical/psychiatric condition (including laboratory abnormalities) that compromises safety or the ability to provide informed consent; or any psychological, familial, social, or geographical conditions that may affect protocol compliance and follow-up.
  • Investigator's Discretion: Any other reason that the investigator deems the patient unsuitable for participation in this clinical trial.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yao Zhu contact

13816751347

zhuyao@fudan.edu.cn

XuDong Ni contact

19946234803

xdni18@fudan.edu.cn

China3 sites, 3 recruiting

  • Fujian Cancer Hospital

    Fujian

    Yao Zhu, 13816751347, zhuyao@fudan.edu.cn

    Yao Zhu

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai

    Yao Zhu, 13816751347, zhuyao@fudan.edu.cn

    Yao Zhu

    Recruiting

  • Fudan University Shanghai Cancer Center Xiamen Branch

    Xiamen

    Yao Zhu, 13816751347, zhuyao@fudan.edu.cn

    Yao Zhu

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Randomized, Controlled Phase II Study of SHR-1701 in Combination With Stereotactic Body Radiotherapy (SBRT) for Metastatic Castration-Resistant Prostate Cancer

The aim of this study is to evaluate the efficacy of SHR-1701 in combination with SBRT in patients with metastatic castration-resistant prostate cancer. Dr. Yao Zhu from Fudan University Shanghai Cancer Center is the co-leading PI of this study.

Being tested
SHR-1701 + SBRT, SBRT
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • SHR-1701 + SBRTCombination product

    Stereotactic body radiotherapy on targeted metastasis determined by MDT + SHR1701 30mg/kg IV every 3 weeks (Q3W) for 2 cycles, then SHR1701 alone Q3W until progression

  • SBRTRadiation

    Stereotactic body radiotherapy on targeted metastasis determined by MDT

Study groups in NCT07451795
Study groupRoleWhat they receive
Radiotherapy plus immunotherapy groupExperimentalStereotactic body radiotherapy on targeted metastasis determined by MDT + SHR1701 30mg/kg IV every 3 weeks (Q3W) for 2 cycles, then SHR1701 alone Q3W until progression
Receives: Combination Product: SHR-1701 + SBRT
Radiotherapy alone groupActive comparatorStereotactic body radiotherapy on targeted metastasis determined by MDT
Receives: Radiation: SBRT

What is being measured

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

  1. Radiographic Progression-Free Survival (rPFS)

    Description: Defined as bone disease progression (occurrence of two or more new lesions on bone scan) per PCWG3, or soft tissue/clinical progression per RECIST v1.1.

    Measured: From randomization to radiographic progression or death (up to 24 months)

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

    The proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR), as assessed by RECIST v1.1 and PCWG3 criteria.

    Measured: From randomization until progression (up to 24 months)

  2. PSA Response Rate

    The proportion of patients achieving a ≥ 50% reduction in serum PSA from baseline, confirmed by a second measurement at least 3 weeks later.

    Measured: From randomization until progression (up to 24 months)

  3. PSA Progression-Free Survival (PSA-PFS)

    Defined according to PCWG3 criteria as: (1) For patients with a decline from baseline: A ≥ 25% increase in PSA and an absolute increase of ≥ 2 ng/mL above the nadir, confirmed by a second measurement at least 3 weeks later; (2) For patients without a decline from baseline: A ≥ 25% increase in PSA and an absolute increase of ≥ 2 ng/mL from baseline after at least 12 weeks of intervention. Subjects with PSA progression alone in the absence of symptomatic or radiographic progression may continue treatment at the investigator's discretion if clinical benefit is perceived.

    Measured: From randomization until progression (up to 24 months)

  4. Overall Survival (OS)

    Defined as the time from enrollment to death from any cause.

    Measured: From randomization until death (up to 24 months)

  5. Safety and Tolerability

    The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.

    Measured: up to 24 months

Timeline

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

  1. First posted5 Mar 2026
  2. Study start2 Mar 2026
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07451795
Sponsor's protocol ID
2509328-15
Acronym
SHARP
Status last verified
Mar 2026
First submitted
24 Dec 2025
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-1701 + SBRT and SBRT in people with Prostate Cancer and mCRPC (Metastatic Castration-resistant Prostate Cancer), run by Fudan University at 3 sites in China.

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 20 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 30 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 3 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Yao Zhu (13816751347, zhuyao@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Progression-Free Survival (rPFS) (time frame: From randomization to radiographic progression or death (up to 24 months)). 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 NCT07451795.

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 30 Apr 2026.

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