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New treatment option for Prostate Cancer
Official title Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
ClinicalTrials.gov ID: NCT05753566
What this study is testing
What is Rezvilutamide?
Rezvilutamide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for prostate cancer.
Also referred to as SHR3680.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older, men only
You may be able to join if
- Main
- Age ≥ 40 years, male.
- Patients with histologically-confirmed diagnosis of prostate adenocarcinoma.
- pathologically node-negative (pN0) or pathologically node cannot be assessed (pNx);
- Patients with PSA \< 0.1ng/ml within 8 weeks after radical prostatectomy (RP) and maintained for at least 6 months;
You likely can't join if
- Prior hormonal therapy (antiandrogens or gonadotropin releasing hormone) or prior radiotherapy to pelvic .
- Postoperative biochemical recurrence with PSA \> 2 ng/ml.
- Postoperative pathology containing neuro-endocrine differentiation or small cell features.
- Prior malignancy other than prostate cancer in the past three years.
- History of any of the following:
- Seizure or known condition that may pre-dispose to seizure
See the full eligibility criteria
- Main
- Age ≥ 40 years, male.
- Patients with histologically-confirmed diagnosis of prostate adenocarcinoma.
- pathologically node-negative (pN0) or pathologically node cannot be assessed (pNx);
- Patients with PSA \< 0.1ng/ml within 8 weeks after radical prostatectomy (RP) and maintained for at least 6 months;
- 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...
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
- Estimated life expectancy \>10 year;
- 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%.
- Patients able to comply with the protocol. Arm 1 people are proposed to receive salvage radiation therapy, while arm 2 people are not suitable for or refuse radiation therapy.
- Signed informed consent. Main
- Prior hormonal therapy (antiandrogens or gonadotropin releasing hormone) or prior radiotherapy to pelvic .
- Postoperative biochemical recurrence with PSA \> 2 ng/ml.
- Postoperative pathology containing neuro-endocrine differentiation or small cell features.
- Prior malignancy other than prostate cancer in the past three years.
- 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)...
- Active infection (eg, human immunodeficiency virus [HIV] or viral hepatitis)
- Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.