Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer

NCT05753566 | Recruiting Phase 2

• 1 other identifier: IUNU-PC-119
• Study Type: interventional
• Target: 96
• 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 rezvilutamide in 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 (2)

• 2-year biochemical progression-free survival

  For arm 1, biochemical progression is defined as a confirmed prostate specific antigen (PSA) greater than (\>) 0.2 nanogram per milliliter (ng/ml)

  24 months

• 3-year biochemical progression-free survival

  For arm 2, biochemical progression is defined as a confirmed PSA greater than (\>) 0.2 ng/ml( the time interval should be over 2 weeks)

  36 months

Secondary Outcomes (9)

• biochemical progression-free survival

  36 months

• progression-free survival (PFS)

  36 months

• metastasis-free survival (MFS)

  36 months

• Quality of life as determined by FACT-P scores

  At baseline, 3 months, 6 months, every 3 months up to 3 years

• Quality of life as determined by EPIC-26 questionnaire

  At baseline, 3 months, 6 months, every 3 months up to 3 years

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

Rezvilutamide +ADT

EXPERIMENTAL

Rezvilutamide along with ADT for 12 cycles (28 days for each cycle)

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

Interventions

Rezvilutamide DRUG

Specifications of 80 mg; orally, once a day

Also known as: SHR3680

Rezvilutamide +ADT; 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

Rezvilutamide +ADT; 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)

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:

• Age ≥ 40 years, male.
• Patients with histologically-confirmed diagnosis of prostate adenocarcinoma.
• pathologically node-negative (pN0) or pathologically node cannot be assessed (pNx);
• Patients with PSA \< 0.1ng/ml within 8 weeks after radical prostatectomy (RP) and maintained for at least 6 months;
• Biochemical recurrence (two consecutive rises in PSA with absolute values \> 0.2ng/ml, the time interval ≥ 2 weeks apart ) and no local recurrence or distant metastatic lesions on conventional imaging (bone scan and CT/MRI scan);
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
• Estimated life expectancy \>10 year;
• Adequate laboratory parameters
• Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\^9/L
• Platelet count (PLT) ≥ 100 x 10\^9/L
• Haemoglobin (Hb) ≥ 90 g/L
• Serum creatinine (Cr) ≤ 1.5 x upper limit of normal(ULN) or creatinine clearance \> 50 ml/min.
• Total bilirubin (TBIL) ≤ 1.5 x ULN.
• Glutamic oxaloacetic transaminase (AST/SGOT) or glutamic alanine transaminase (ALT/SGPT) levels ≤ 2.5 x ULN.
• International normalised ratio (INR) ≤1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT)≤1.5 x ULN .

You may not qualify if:

• Prior hormonal therapy (antiandrogens or gonadotropin releasing hormone) or prior radiotherapy to pelvic .
• Postoperative biochemical recurrence with PSA \> 2 ng/ml.
• Postoperative pathology containing neuro-endocrine differentiation or small cell features.
• Prior malignancy other than prostate cancer in the past three years.
• History of any of the following:
• Seizure or known condition that may pre-dispose to seizure
• Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to entry.
• Active infection (eg, human immunodeficiency virus \[HIV\] or viral hepatitis)
• Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (2)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210000, China

RECRUITING

JiangSu Cancer Hospital

Nanjing, Jiangsu, China

NOT YET 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

Study Officials

• Chief physician of Department of Urology

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongqian Guo, phD

CONTACT

+86-13605171690; dr.ghq@nju.edu.cn

Shun Zhang, MD

CONTACT

+86-15050589789; explorershun@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician of Department of Urology

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 3, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)