Actively Recruiting
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2024-03-12
102
Participants Needed
2
Research Sites
233 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, aged 40 years or older
- Postoperative pathology showing prostate adenocarcinoma
- Postoperative pathological stage pN0 or pNx
- PSA level less than 0.1 ng/ml within 8 weeks after radical prostatectomy for at least 6 months
- Biochemical recurrence defined as PSA rising twice consecutively with at least 2 weeks interval and absolute value above 0.2 ng/ml
- No local recurrence or distant metastasis on traditional imaging (bone scan and CT/MRI)
- At least one risk factor: postoperative CAPRA-S score 6 or higher, Gleason score 8-10, highest postoperative biochemical recurrence PSA above 0.5 ng/ml, pathological stage PT3/T4, or PSA doubling time less than 10 months
- ECOG performance status 0-1
- Life expectancy greater than 10 years
- Adequate blood counts and organ function within 4 weeks prior to treatment
- Willingness and ability to sign informed consent and comply with study requirements
You will not qualify if you...
- Previous endocrine therapy for prostate cancer or pelvic radiotherapy
- Postoperative biochemical recurrence with PSA more than 2 ng/ml
- Postoperative pathology containing non-adenocarcinoma components such as neuroendocrine differentiation or small cell features
- Current or prior participation in an investigational drug study
- Known or suspected allergy to rezvilutamide or its components
- Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors affecting drug absorption
- History of epilepsy or conditions inducing seizures within 12 months prior to treatment
- Active heart disease within 6 months prior to treatment including severe angina, myocardial infarction, symptomatic heart failure, or ventricular arrhythmias
- Other malignancies within 3 years prior to treatment except certain in situ carcinomas or slowly progressing cancers
- Use of granulocyte colony-stimulating factor within 2 weeks before treatment
- Blood transfusion within 2 weeks before treatment
- Active hepatitis B or C infection
- History of immunodeficiency or organ transplantation
- Male patients whose partners are fertile women who refuse surgical sterilization or effective contraception during and for 3 months after treatment
- Investigator judgment of inability to comply or risks to study conduct
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
2
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
H
Hongqian Guo, phD
CONTACT
S
Shun Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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