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

NCT06305832 | Recruiting Phase 2

• 1 other identifier: IUNU-PC-120
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

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

Keywords

Prostate cancer; Biochemical recurrence; Rezvilutamide

Outcome Measures

Primary Outcomes (1)

• 3-year biochemical progression-free survival

  biochemical progression is defined as a confirmed prostate specific antigen (PSA) greater than (\>) 0.2 nanogram per milliliter (ng/ml) ( the time interval should be over 2 weeks)

  48 months

Secondary Outcomes (6)

• progression-free survival (PFS)

  48 months

• metastasis-free survival (MFS)

  48 months

• percentage of undetectable PSA

  48 months

• ctDNA-positive rate

  48 months

• ctDNA clearance rate

  48 months

Study Arms (2)

Rezvilutamide +ADT+ SRT

EXPERIMENTAL

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

Drug: Rezvilutamide; Drug: Androgen deprivation therapy (ADT); Radiation: SRT

ADT+ SRT

OTHER

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

Drug: Androgen deprivation therapy (ADT); Radiation: SRT

Interventions

Rezvilutamide DRUG

Specifications of 80 mg; orally, once a day

Also known as: SHR3680

Rezvilutamide +ADT+ SRT

Androgen deprivation therapy (ADT) 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

ADT+ SRT; Rezvilutamide +ADT+ SRT

SRT 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; Rezvilutamide +ADT+ SRT

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. ≥40 years old, male;
• \. Postoperative pathology showed prostate adenocarcinoma;
• \. Postoperative pathological stage pN0 or pNx;
• \. PSA decline \< 0.1ng/ml within 8 weeks after radical prostate cancer surgery for at least 6 months
• \. 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.
• \. 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;
• \. ECOG status is 0-1;
• \. Life expectancy greater than 10 years;
• \. 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);

You may not qualify if:

• \. 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;
• \. Postoperative biochemical recurrence, but PSA more than 2 ng/ml;
• \. Postoperative pathology contains non-adenocarcinoma components, such as neuroendocrine differentiation or small cell features;
• \. Is currently participating in or has participated in an investigational drug study;
• \. Known or suspected allergy to reverumide and reverumide excipients;
• \. Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect drug use and absorption;
• \. 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);
• \. 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;
• \. 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);
• \. Granulocyte colony-stimulating factor was used for support 2 weeks before C1D1;
• \. Blood transfusion within 2 weeks before C1D1;
• \. Active HBV and HCV infected persons (HBV copy number ≥10\^4 copies /mL, HCV copy number ≥10\^3 copies /mL);
• \. A history of immunodeficiency (including HIV positive, other acquired, congenital immunodeficiency diseases) or a history of organ transplantation;
• \. 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.
• \. 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (2)

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

Nanjing, Jiangsu, 210000, China

RECRUITING

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Hongqian Guo, phD

CONTACT

13605171690; dr.ghq@nju.edu.cn

Shun Zhang, MD

CONTACT

15050589789; explorershun@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: September 7, 2023
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)