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Trial Title:
Radiation and Adebrelimab in Prostate Cancer With Imaging-measurable Disease (RAPID)
NCT ID:
NCT06251492
Condition:
Prostate Cancer Metastatic
Castration-resistant Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Stereotactic body radiotherapy
Description:
8 Gray x 3 for 2 cycles
Arm group label:
Experimental Group
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
Adebrelimab 20mg/kg IV Q3W for 2 cycles, then Adebrelimab 20mg/kg IV alone Q3W until
progression
Arm group label:
Experimental Group
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male with 18-75 years of age at the time consent form is signed
2. 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);
3. 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;
4. Disease progression after treatment with ≥1 androgen-receptor (AR) targeted
therapies (such as abiraterone acetate, enzalutamide, apalutamide, darolutamide,
etc.);
5. Disease progression after treatment with ≥1 line of taxane-based chemotherapy or
intolerant to chemotherapy;
6. 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;
7. 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）；
8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2;
9. Expected survival ≥6 months;
10. 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;
11. 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
12. Total bilirubin ≤1.5 times ULN or total bilirubin >1.5 times ULN and direct
bilirubin ≤ULN;
13. Normal coagulation function: INR ≤1.5, partial thromboplastin time (APTT) ≤1.5 times
ULN, prothrombin time (PT)
Gender:
Male
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Contact:
Last name:
Yao Zhu
Phone:
13816751347
Email:
zhuyao@fudan.edu.cn
Investigator:
Last name:
Yao Zhu
Email:
Principal Investigator
Facility:
Name:
Fudan University Shanghai Cancer Center Xiamen Branch.
Address:
City:
Xiamen
Zip:
361000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yao Zhu
Phone:
13816751347
Email:
zhuyao@fudan.edu.cn
Investigator:
Last name:
Yao Zhu
Email:
Principal Investigator
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yao Zhu
Phone:
13816751347
Email:
zhuyao@fudan.edu.cn
Investigator:
Last name:
Yao Zhu
Email:
Principal Investigator
Start date:
January 30, 2024
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06251492
