Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
NCT ID: NCT05753566
Last Updated: 2023-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
96 participants
INTERVENTIONAL
2023-03-31
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
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)
Rezvilutamide +ADT
Rezvilutamide along with ADT for 12 cycles (28 days for each cycle)
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
Interventions
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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
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
40 Years
MALE
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Responsible Party
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Hongqian Guo
Chief physician of Department of Urology
Principal Investigators
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Chief physician of Department of Urology
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Locations
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
JiangSu Cancer Hospital
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Qing Zou
Role: primary
Other Identifiers
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IUNU-PC-119
Identifier Type: -
Identifier Source: org_study_id
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