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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05753566
• Other study ID #: IUNU-PC-119
• Status: Recruiting
• Phase: Phase 2
• Start date: March 2023
• Est. completion date: March 2028

Study information

• Verified date: March 2023
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Hongqian Guo, phD
• Phone: +86-13605171690
• Email: dr.ghq[@]nju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: March 2028
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biochemical Recurrence
• Prostate Cancer
• Prostatic Neoplasms
• Recurrence

Intervention

Drug:
• Rezvilutamide
Specifications of 80 mg; orally, once a day
• 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)

Locations

Country	Name	City	State
China	JiangSu Cancer Hospital	Nanjing	Jiangsu
China	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	biochemical progression-free survival	Time from entry to biochemical progression or death due to any cause.	36 months
Secondary	progression-free survival (PFS)	Time from entry to biochemical progression or radiologically confirmed progressive disease or death due to any cause.	36 months
Secondary	metastasis-free survival (MFS)	Time from entry to radiologically confirmed metastasis disease or death due to any cause.	36 months
Secondary	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
Secondary	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
Secondary	Number of Adverse Events	Number of Adverse Events	36 months
Secondary	Duration of testosterone recovery	Duration of testosterone recovery	36 months
Secondary	Time to testosterone recovery to >50 ng/dl	Time to testosterone recovery to >50 ng/dl	36 months
Secondary	Time to testosterone recovery to >300 ng/dl	Time to testosterone recovery to >300 ng/dl	36 months