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Trial Title:
Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
NCT ID:
NCT05753566
Condition:
Prostate Cancer
Biochemical Recurrence
Conditions: Official terms:
Prostatic Neoplasms
Recurrence
Androgens
Conditions: Keywords:
Prostate cancer
Biochemical recurrence
Rezvilutamide
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Rezvilutamide
Description:
Specifications of 80 mg; orally, once a day
Arm group label:
Rezvilutamide +ADT
Arm group label:
Rezvilutamide +ADT+ SRT
Other name:
SHR3680
Intervention type:
Drug
Intervention name:
Androgen deprivation therapy (ADT)
Description:
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
Arm group label:
Rezvilutamide +ADT
Arm group label:
Rezvilutamide +ADT+ SRT
Intervention type:
Radiation
Intervention name:
SRT
Description:
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)
Arm group label:
Rezvilutamide +ADT+ SRT
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).
Criteria for eligibility:
Criteria:
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.
Gender:
Male
Minimum age:
40 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongqian Guo, Phd
Phone:
8613605171690
Email:
dr.ghq@nju.edu.cn
Contact backup:
Last name:
Shun Zhang, MD
Phone:
8615050589789
Email:
explorershun@126.com
Facility:
Name:
JiangSu Cancer Hospital
Address:
City:
Nanjing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Qing Zou
Start date:
March 2023
Completion date:
March 2028
Lead sponsor:
Agency:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class:
Other
Collaborator:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05753566
