Actively Recruiting
Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2023-03-06
96
Participants Needed
2
Research Sites
261 weeks
Total Duration
On this page
Sponsors
T
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead Sponsor
J
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsor
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 rezvilutamide in combination with ADT in prostate cancer patients with biochemical recurrence of prostate-specific antigen(PSA) persistence after radical prostatectomy(RP).
CONDITIONS
Official Title
Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 40 years or older
- Histologically confirmed prostate adenocarcinoma
- Pathologically node-negative (pN0) or node status not assessed (pNx)
- PSA less than 0.1 ng/ml within 8 weeks after radical prostatectomy, maintained for 6 months
- Biochemical recurrence defined by two consecutive PSA rises above 0.2 ng/ml at least 2 weeks apart, with no local or distant metastases
- ECOG performance status of 0 to 1
- Estimated life expectancy greater than 10 years
- Adequate lab values including ANC ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L, hemoglobin ≥ 90 g/L, serum creatinine ≤ 1.5 times upper limit of normal or creatinine clearance > 50 ml/min, total bilirubin ≤ 1.5 times upper limit of normal, AST/ALT ≤ 2.5 times upper limit of normal, INR ≤ 1.5 and PT/APTT ≤ 1.5 times upper limit of normal, left ventricular ejection fraction ≥ 50%
- Ability to comply with study protocol
- Signed informed consent
You will not qualify if you...
- Prior hormonal therapy or radiotherapy to the pelvic area
- Postoperative biochemical recurrence with PSA greater than 2 ng/ml
- Postoperative pathology showing neuroendocrine differentiation or small cell features
- Other malignancies within the past three years besides prostate cancer
- History of seizures or conditions increasing seizure risk
- Recent severe heart conditions or significant cardiovascular events within 6 months
- Active infections such as HIV or viral hepatitis
- Any serious or uncontrolled illness deemed unsuitable for trial participation by the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210000
Actively Recruiting
2
JiangSu Cancer Hospital
Nanjing, Jiangsu, China
Not Yet Recruiting
Research Team
H
Hongqian Guo, phD
CONTACT
S
Shun Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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