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

Efficacy and Safety of Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer: A Prospective, Multi-centre Study

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).

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Biochemical Recurrence
• Intervention / Treatment: Drug: Rezvilutamide; Drug: Androgen deprivation therapy (ADT); Radiation: SRT

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hongqian Guo, PhD; Phone Number: +86-13605171690; Email: dr.ghq@nju.edu.cn
• Study Contact Backup: Name: Shun Zhang, MD; Phone Number: +86-15050589789; Email: explorershun@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    • Nanjing, Jiangsu, China
      • Not yet recruiting
      • Jiangsu Cancer Hospital
      • Contact: Qing Zou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Main Inclusion Criteria:

1. Age ≥ 40 years, male.
2. Patients with histologically-confirmed diagnosis of prostate adenocarcinoma.
3. pathologically node-negative (pN0) or pathologically node cannot be assessed (pNx);
4. Patients with PSA < 0.1ng/ml within 8 weeks after radical prostatectomy (RP) and maintained for at least 6 months;
5. 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);
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
7. Estimated life expectancy >10 year;

8. 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 .
   • Left ventricular ejection fraction (LVEF) ≥ 50%.
9. Patients able to comply with the protocol. Arm 1 subjects are proposed to receive salvage radiation therapy, while arm 2 subjects are not suitable for or refuse radiation therapy.
10. Signed informed consent.

Main Exclusion Criteria:

1. Prior hormonal therapy (antiandrogens or gonadotropin releasing hormone) or prior radiotherapy to pelvic .
2. Postoperative biochemical recurrence with PSA > 2 ng/ml.
3. Postoperative pathology containing neuro-endocrine differentiation or small cell features.
4. Prior malignancy other than prostate cancer in the past three years.

5. 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)
6. Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Rezvilutamide; Specifications of 80 mg; orally, once a day; Other Names: SHR3680; 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; Radiation: 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)
Experimental: Rezvilutamide +ADT; Rezvilutamide along with ADT for 12 cycles (28 days for each cycle)	Drug: Rezvilutamide; Specifications of 80 mg; orally, once a day; Other Names: SHR3680; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
biochemical progression-free survival	Time from entry to biochemical progression or death due to any cause.	36 months
progression-free survival (PFS)	Time from entry to biochemical progression or radiologically confirmed progressive disease or death due to any cause.	36 months
metastasis-free survival (MFS)	Time from entry to radiologically confirmed metastasis disease or death due to any cause.	36 months
Quality of life as determined by FACT-P scores	Quality of life as determined by Functional Assessment of Cancer Therapy-Prostate (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	Quality of life as determined by Expanded Prostate Cancer Index Composite-26 (EPIC-26) questionnaire	At baseline, 3 months, 6 months, every 3 months up to 3 years
Number of Adverse Events	Number of Adverse Events	36 months
Duration of testosterone recovery	Duration of testosterone recovery	36 months
Time to testosterone recovery to >50 ng/dl	Time to testosterone recovery to >50 ng/dl	36 months
Time to testosterone recovery to >300 ng/dl	Time to testosterone recovery to >300 ng/dl	36 months

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Chief physician of Department of Urology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): March 1, 2027
• Study Completion (Anticipated): March 1, 2028

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Prostate cancer; Biochemical recurrence; Rezvilutamide
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Disease Attributes; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Recurrence; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens
• Other Study ID Numbers: IUNU-PC-119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No