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

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-07
• Study Completion Date: 2028-03-31

Brief 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).

Conditions

Prostate Cancer; Biochemical Recurrence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rezvilutamide +ADT+ SRT

Rezvilutamide along with ADT for 6 cycles (28 days for each cycle) in combination with salvage radiation therapy (SRT) according to standard of care

Group Type: EXPERIMENTAL

Rezvilutamide

Intervention Type: DRUG

Specifications of 80 mg; orally, once a day

Androgen deprivation therapy (ADT)

Intervention Type: DRUG

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

SRT

Intervention Type: RADIATION

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)

ADT+ SRT

ADT for 6 cycles (28 days for each cycle) in combination with salvage radiation therapy (SRT) according to standard of care

Group Type: OTHER

Androgen deprivation therapy (ADT)

Intervention Type: DRUG

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

SRT

Intervention Type: RADIATION

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)

Interventions

Rezvilutamide

Specifications of 80 mg; orally, once a day

Intervention Type: DRUG

Androgen deprivation therapy (ADT)

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

Intervention Type: DRUG

SRT

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)

Intervention Type: RADIATION

Other Intervention Names

SHR3680

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Hongqian Guo

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Nanjing, Jiangsu, China

Site Status: RECRUITING

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongqian Guo, phD

Role: CONTACT

dr.ghq@nju.edu.cn

13605171690

Shun Zhang, MD

Role: CONTACT

explorershun@126.com

15050589789

Facility Contacts

Shun Zhang

Role: primary

explorershun@126.com

15050589789 ext. 15050589789

Hongqian Guo, Phd

Role: primary

dr.ghq@nju.edu.cn

13605171690

Shun Zhang

Role: backup

Other Identifiers

IUNU-PC-120

Identifier Type: -

Identifier Source: org_study_id