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Trial Title: Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer

NCT ID: NCT06305832

Condition: Prostate Cancer
Biochemical Recurrence

Conditions: Official terms:
Prostatic Neoplasms
Recurrence
Androgens

Conditions: Keywords:
Prostate cancer
Biochemical recurrence
Rezvilutamide

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Rezvilutamide
Description: Specifications of 80 mg; orally, once a day
Arm group label: Rezvilutamide +ADT+ SRT

Other name: SHR3680

Intervention type: Drug
Intervention name: Androgen deprivation therapy (ADT)
Description: Androgen deprivation therapy (ADT), the ADT used by each subject will be determined by the investigator,and the dose and frequency of administration will be consistent with the prescription information
Arm group label: ADT+ SRT
Arm group label: Rezvilutamide +ADT+ SRT

Intervention type: Radiation
Intervention name: SRT
Description: SRT according to standard of care (66.6-72 grays will be delivered to the bed of prostate ,~50.4 grays to the pelvis if needed)
Arm group label: ADT+ SRT
Arm group label: Rezvilutamide +ADT+ SRT

Summary: To evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy(ADT) and standard salvage radiation therapy(SRT) or SRT combination with ADT in prostate cancer patients with biochemical recurrence of prostate-specific antigen(PSA) persistence after radical prostatectomy(RP).

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 1. ≥40 years old, male; - 2. Postoperative pathology showed prostate adenocarcinoma; - 3. Postoperative pathological stage pN0 or pNx; - 4. PSA decline < 0.1ng/ml within 8 weeks after radical prostate cancer surgery for at least 6 months - 5. Biochemical recurrence (PSA rose twice in a row, with an interval of ≥2 weeks and absolute value > 0.2ng/ml), and traditional imaging (bone scan and CT/MRI scan) did not show local recurrence and distant metastasis. - 6. Have one or more of the following risk factors: - Postoperative CAPRA-S score ≥6 points; - The pathological score of radical surgery for prostate cancer was Gleason 8-10; - The highest postoperative biochemical recurrence PSA > 0.5ng/ml; - Postoperative pathological stage PT3/T4; - PSADT < 10 months; - 7. ECOG status is 0-1; - 8. Life expectancy greater than 10 years; - 9. Adequate hematological and organ function tests within 4 weeks prior to the first study treatment, as defined below: - Neutrophil count (ANC)≥1.5×10^9/L (no granulocyte colony-stimulating factor for 2 weeks prior to cycle 1, day 1); - Platelet count (PLT)≥100×10^9/L (no transfusion within 2 weeks prior to day 1 of cycle 1); - Hemoglobin (Hb) ≥90g/L - Serum creatinine (Cr)≤1.5×ULN or creatinine clearance > 50ml/min; - Total bilirubin (BIL)≤1.5×ULN; - Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) level ≤2.5×ULN; - International Standardized ratio (INR) ≤1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN; - Left ventricular ejection fraction (LVEF) ≥50%; - 10. The subject is willing and understands to sign the informed consent and is able to comply with the agreement. Exclusion Criteria: - 1. Previously received endocrine therapy for prostate cancer (including but not limited to goserrelin, levoprorelin, digarek, bicalutamide, abiraterone acetate, darotamine, apatamide, enzalutamide, etc.) or pelvic radiotherapy; - 2. Postoperative biochemical recurrence, but PSA more than 2 ng/ml; - 3. Postoperative pathology contains non-adenocarcinoma components, such as neuroendocrine differentiation or small cell features; - 4. Is currently participating in or has participated in an investigational drug study; - 5. Known or suspected allergy to reverumide and reverumide excipients; - 6. Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect drug use and absorption; - 7. Have a history of epilepsy, or a medical condition that can induce seizures within the 12 months prior to C1D1 (including a history of transient ischemic attacks, cerebral stroke, traumatic brain injury with disturbance of consciousness requiring hospitalization); - 8. Active heart disease in the 6 months prior to C1D1, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and medically treatable ventricular arrhythmias; - 9. Have had any other malignancies within the 3 years prior to C1D1 (except for carcinoma in situ that has been in complete remission and malignancies that the investigator determined to be slowly progressing); - 10. Granulocyte colony-stimulating factor was used for support 2 weeks before C1D1; - 11. Blood transfusion within 2 weeks before C1D1; - 12. Active HBV and HCV infected persons (HBV copy number ≥10^4 copies /mL, HCV copy number ≥10^3 copies /mL); - 13. A history of immunodeficiency (including HIV positive, other acquired, congenital immunodeficiency diseases) or a history of organ transplantation; - 14. Male subjects whose partner is a fertile woman refuse surgical sterilization or use of effective contraception during the trial period and for 3 months after the last dose of riverutamide. - 15. The investigator determines subjects who may affect the conduct of clinical studies, who may not be able to comply with the protocol or cooperate with the protocol, and who pose research risks.

Gender: Male

Minimum age: 40 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Address:
City: Nanjing
Zip: 210000
Country: China

Status: Recruiting

Contact:
Last name: Shun Zhang

Phone: 15050589789

Phone ext: 15050589789
Email: explorershun@126.com

Facility:
Name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Address:
City: Nanjing
Zip: 210000
Country: China

Status: Recruiting

Contact:
Last name: Hongqian Guo, Phd

Phone: 13605171690
Email: dr.ghq@nju.edu.cn

Contact backup:
Last name: Shun Zhang

Investigator:
Last name: Hongqian Guo
Email: Principal Investigator

Start date: September 7, 2023

Completion date: March 2028

Lead sponsor:
Agency: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class: Other

Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06305832

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