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Prostate Cancer MetastaticPhase 2NCT06251492

Radiation and Adebrelimab in Prostate Cancer With Imaging-measurable Disease (RAPID)

A Phase 2 study testing Stereotactic body radiotherapy and Adebrelimab in people with Prostate Cancer Metastatic and Castration-resistant Prostate Cancer, run by Fudan University at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to evaluate the efficacy of 2 cycles of combinatory adebrelimab and stereotactic radiotherapy, followed by monotherapy adebrelimab 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 75 years, men only
What is being tested?
Stereotactic body radiotherapy and Adebrelimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesChina
Study dates
30 Jan 2024to 30 Dec 2025
Phase
Phase 2
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 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male with 18-75 years of age at the time consent form is signed
  • The patient must have histologically or cytologically confirmed prostate adenocarcinoma, which has been determined to be metastatic prostate cancer based on routine imaging assessment (bone scan or CT/MRI);
  • The patient has assessable visceral metastases or soft tissue lesions (outside the pelvis), and the patient should undergo image-guided lesion puncture before medication if considered safe assessed by the PI;
  • Disease progression after treatment with ≥1 androgen-receptor (AR) targeted therapies (such as abiraterone acetate, enzalutamide, apalutamide, darolutamide, etc.);
  • Disease progression after treatment with ≥1 line of taxane-based chemotherapy or intolerant to chemotherapy;
  • The patient shows PSA progression (defined as an increase in PSA levels at least twice consecutively, with an interval of at least one week between assessments, and a PSA value of ≥1 ng/mL at screening), or according to RECIST 1.1 criteria, imaging progression of soft tissue disease with or without PSA progression, or bone lesion progression according to PCWG3 standards: bone scan reveals ≥2 new bone lesions;
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  • The patient needs to maintain effective and continuous treatment with luteinizing hormone-releasing hormone analogs (LHRHa) throughout the study treatment, or has undergone orchiectomy; and serum testosterone levels must be maintained at castration level（<50 ng/dL）；
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2;
  • Expected survival ≥6 months;
  • Normal bone marrow function: absolute neutrophil count ≥1.5×10^9/L; platelets ≥75×10^9/L; hemoglobin ≥90g/L; white blood cell count ≥3.0×10^9/L;
  • Normal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN); for patients with liver metastases, ALT/AST may be ≤5 times ULN
  • Total bilirubin ≤1.5 times ULN or total bilirubin \&gt;1.5 times ULN and direct bilirubin ≤ULN;
  • Normal coagulation function: INR ≤1.5, partial thromboplastin time (APTT) ≤1.5 times ULN, prothrombin time (PT) <ULN+4 seconds;
  • Normal cardiac function: left ventricular ejection fraction (LVEF) ≥50%; QTc <450ms for males, <470ms for females, blood potassium ≥3.5mmol/L;
  • Normal blood pressure: systolic <160mmHg, diastolic <95mmHg; patients with stable blood pressure assessment after appropriate clinical treatment can be enrolled;
  • Normal renal function: serum creatinine ≤1.5 times ULN, and creatinine clearance rate ≥50 mL/min;
  • Researchers consider patients who are capable of ejaculation and are sexually active must agree to take effective contraceptive measures and not donate sperm from the first administration of the study drug to 3 months after the last administration;
  • Able to understand and is willing to sign an informed consent form;
  • Able to comply with the study visit schedule and other protocol requirements.

Who cannot join

  • Planning to receive any other antitumor treatments during the study treatment period;
  • Metastatic lesions are limited to bone metastases or include brain metastases;
  • Previous treatment with immune checkpoint inhibitors (including PD-1, PD-L1, CTLA-4 inhibitors, etc.), or antitumor drugs targeting T-cells and activating the immune system;
  • In the past 3 years, having a known other malignancy that is progressing or requiring active treatment. Subjects with skin basal cell carcinoma, skin squamous cell carcinoma, or in situ carcinoma who have received potentially curative treatment may enroll in the study.
  • In the past 2 years, have active autoimmune diseases requiring systemic treatment (such as with disease-modifying drugs, corticosteroids, or immunosuppressive drugs) or active infections (including tuberculosis). Replacement therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for renal or pituitary insufficiency) is not considered systemic treatment.
  • Diagnosed with immunodeficiency or receiving chronic systemic steroid treatment (daily use of more than 10 mg of prednisone or equivalent doses) or any other form of immunosuppressive treatment within 14 days prior to the first dose of the study intervention.
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  • Have a history of (non-infectious) pneumonia that required steroid treatment or currently suffering from non-infectious pneumonia.
  • Have received radiation therapy or radionuclide therapy (such as Radium-223) within 28 days prior to the study drug administration; or having been treated with abiraterone within one week prior, with cyproterone acetate within ten days prior, or antiandrogen therapy within two weeks prior.
  • Allergic or intolerant to the active ingredient of PD-L1 monoclonal antibody or any excipient;
  • A clear history of neurological and psychiatric disorders, such as dementia, epilepsy, or a tendency for seizures;
  • In the judgment of the researcher, severe concomitant diseases that pose a serious risk to the subject's safety or affect the subject's completion of the study (such as severe diabetes, thyroid disease, and mental illness, etc.), or the presence of severe and/or unstable medical, psychiatric, or other conditions that affect patient safety or the patient's ability to provide informed consent (including laboratory abnormalities), or any psychological, familial, sociological, or geographical conditions that may affect the study protocol and follow-up plan;
  • The researcher considers the subject unsuitable for participation in the clinical trial for any reason.

Trial locations and contacts

3 sites in 1 country.

Yao Zhu contact

13816751347

zhuyao@fudan.edu.cn

Yu Wei contact

17621008152

yuwei21@m.fudan.edu.cn

China3 sites, 3 recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

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

    Yao Zhu

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

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

    Yao Zhu

    Recruiting

  • Fudan University Shanghai Cancer Center Xiamen Branch.

    Xiamen, Fujian, 361000

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

    Yao Zhu

    Recruiting

Other trials in China

About this study

Official title: Radiation and Adebrelimab in Prostate Cancer With Imaging-measurable Disease (RAPID)：a Prospective, Single-arm, Phase II Clinical Study

The aim of this study is to evaluate the efficacy of 2 cycles of combinatory adebrelimab and stereotactic radiotherapy, followed by monotherapy adebrelimab 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
Stereotactic body radiotherapy, Adebrelimab

What participants receive

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

  • Stereotactic body radiotherapyRadiation

    8 Gray x 3 for 2 cycles

  • AdebrelimabDrug

    Adebrelimab 20mg/kg IV Q3W for 2 cycles, then Adebrelimab 20mg/kg IV alone Q3W until progression

Study groups in NCT06251492
Study groupRoleWhat they receive
Experimental GroupExperimentalStereotactic body radiotherapy of 8 Gray (Gy) x 3 on targeted metastasis determined by MDT + Adebrelimab 20mg/kg IV every 3 weeks (Q3W) for 2 cycles, then Adebrelimab 20mg/kg IV alone Q3W until progression
Receives: Radiation: Stereotactic body radiotherapy; Drug: Adebrelimab

What is being measured

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

  1. Disease Control Rate

    DCR (Disease Control Rate) is defined as the proportion of patients with a confirmed complete response (CR) or partial response (PR) of any duration, or stable disease (SD)/non-CR/nonprogressive disease (non-PD) for ≥6 months according to modified Response Evaluation Criteria in Solid Tumours (RECIST1.1) per Prostate Cancer Clinical Trials Working Group (PCWG3) criteria

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

Secondary outcomes (6)

  1. Objective response rate

    ORR (objective response rate) is defined as the proportion of patients with a confirmed complete response (CR) or partial response (PR) of any duration according to modified Response Evaluation Criteria in Solid Tumours (RECIST1.1) per Prostate Cancer Clinical Trials Working Group (PCWG3) criteria

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

  2. Radiographic progression-free survival

    Defined by radiographic progression by RECIST 1.1 for soft tissue and PCWG3 version 1.1 for bone metastases.

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

  3. PSA progression-free survival

    Time to PSA progression as defined by PCWG3 criteria.

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

  4. PSA response rate

    PSA response per PCWG3. PSA response is defined as a ≥50% decline in PSA from baseline (measured twice at least 3 weeks apart).

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

  5. Overall survival

    Overall survival (OS) is defined as time from start of study treatment to the date of death from any cause. Subjects who are alive will be censored at last follow up date.

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

  6. Functional Assessment of Quality of life of cancer patients

    Determined by the FACT-P (Functional Assessment of Cancer Therapy-Prostate) version 4.

    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 posted9 Feb 2024
  2. Study start30 Jan 2024
  3. Primary completion30 Jul 2025 (estimated)
  4. Study completion30 Dec 2025 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06251492
Sponsor's protocol ID
RAPID
Status last verified
Feb 2024
First submitted
12 Jan 2024
Last updated
20 Feb 2024
Results posted
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 Stereotactic body radiotherapy and Adebrelimab in people with Prostate Cancer Metastatic and 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 19 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. 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?

Results are not available in the source record.

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?

Disease Control Rate (time frame: From baseline until progression (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 NCT06251492.

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 20 Feb 2024.

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