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Trial Title:
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
NCT ID:
NCT06305832
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:
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+ 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:
ADT+ SRT
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:
ADT+ SRT
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 SRT combination
with ADT in prostate cancer patients with biochemical recurrence of prostate-specific
antigen(PSA) persistence after radical prostatectomy(RP).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. ≥40 years old, male;
-
2. Postoperative pathology showed prostate adenocarcinoma;
-
3. Postoperative pathological stage pN0 or pNx;
-
4. PSA decline < 0.1ng/ml within 8 weeks after radical prostate cancer surgery
for at least 6 months
-
5. Biochemical recurrence (PSA rose twice in a row, with an interval of ≥2 weeks
and absolute value > 0.2ng/ml), and traditional imaging (bone scan and
CT/MRI scan) did not show local recurrence and distant metastasis.
-
6. Have one or more of the following risk factors:
- Postoperative CAPRA-S score ≥6 points;
- The pathological score of radical surgery for prostate cancer was Gleason 8-10;
- The highest postoperative biochemical recurrence PSA > 0.5ng/ml;
- Postoperative pathological stage PT3/T4;
- PSADT < 10 months;
-
7. ECOG status is 0-1;
-
8. Life expectancy greater than 10 years;
-
9. Adequate hematological and organ function tests within 4 weeks prior to the
first study treatment, as defined below:
- Neutrophil count (ANC)≥1.5×10^9/L (no granulocyte colony-stimulating factor for
2 weeks prior to cycle 1, day 1);
- Platelet count (PLT)≥100×10^9/L (no transfusion within 2 weeks prior to day 1
of cycle 1);
- Hemoglobin (Hb) ≥90g/L
- Serum creatinine (Cr)≤1.5×ULN or creatinine clearance > 50ml/min;
- Total bilirubin (BIL)≤1.5×ULN;
- Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT)
level ≤2.5×ULN;
- International Standardized ratio (INR) ≤1.5, prothrombin time (PT) and
activated partial thromboplastin time (APTT) ≤1.5×ULN;
- Left ventricular ejection fraction (LVEF) ≥50%;
-
10. The subject is willing and understands to sign the informed consent and is able
to comply with the agreement.
Exclusion Criteria:
-
1. Previously received endocrine therapy for prostate cancer (including but not
limited to goserrelin, levoprorelin, digarek, bicalutamide, abiraterone
acetate, darotamine, apatamide, enzalutamide, etc.) or pelvic radiotherapy;
-
2. Postoperative biochemical recurrence, but PSA more than 2 ng/ml;
-
3. Postoperative pathology contains non-adenocarcinoma components, such as
neuroendocrine differentiation or small cell features;
-
4. Is currently participating in or has participated in an investigational drug
study;
-
5. Known or suspected allergy to reverumide and reverumide excipients;
-
6. Inability to swallow, chronic diarrhea, intestinal obstruction, or other
factors that affect drug use and absorption;
-
7. Have a history of epilepsy, or a medical condition that can induce seizures
within the 12 months prior to C1D1 (including a history of transient ischemic
attacks, cerebral stroke, traumatic brain injury with disturbance of
consciousness requiring hospitalization);
-
8. Active heart disease in the 6 months prior to C1D1, including severe/unstable
angina, myocardial infarction, symptomatic congestive heart failure, and
medically treatable ventricular arrhythmias;
-
9. Have had any other malignancies within the 3 years prior to C1D1 (except for
carcinoma in situ that has been in complete remission and malignancies that the
investigator determined to be slowly progressing);
-
10. Granulocyte colony-stimulating factor was used for support 2 weeks before C1D1;
-
11. Blood transfusion within 2 weeks before C1D1;
-
12. Active HBV and HCV infected persons (HBV copy number ≥10^4 copies /mL, HCV copy
number ≥10^3 copies /mL);
-
13. A history of immunodeficiency (including HIV positive, other acquired,
congenital immunodeficiency diseases) or a history of organ transplantation;
-
14. Male subjects whose partner is a fertile woman refuse surgical sterilization or
use of effective contraception during the trial period and for 3 months after
the last dose of riverutamide.
-
15. The investigator determines subjects who may affect the conduct of clinical
studies, who may not be able to comply with the protocol or cooperate with the
protocol, and who pose research risks.
Gender:
Male
Minimum age:
40 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Recruiting
Contact:
Last name:
Shun Zhang
Phone:
15050589789
Phone ext:
15050589789
Email:
explorershun@126.com
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:
13605171690
Email:
dr.ghq@nju.edu.cn
Contact backup:
Last name:
Shun Zhang
Investigator:
Last name:
Hongqian Guo
Email:
Principal Investigator
Start date:
September 7, 2023
Completion date:
March 2028
Lead sponsor:
Agency:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class:
Other
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/NCT06305832