Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer: a Prospective, Multicenter, Randomized Controlled Clinical Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
RECRUITING
Nanjing
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
RECRUITING
Nanjing
Contact Information
Primary
Hongqian Guo, phD
dr.ghq@nju.edu.cn
13605171690
Backup
Shun Zhang, MD
explorershun@126.com
15050589789
Time Frame
Start Date: 2023-09-07
Estimated Completion Date: 2028-03
Participants
Target number of participants: 102
Treatments
Experimental: Rezvilutamide +ADT+ SRT
Rezvilutamide along with ADT for 6 cycles (28 days for each cycle) in combination with salvage radiation therapy (SRT) according to standard of care
Other: ADT+ SRT
ADT for 6 cycles (28 days for each cycle) in combination with salvage radiation therapy (SRT) according to standard of care
Related Therapeutic Areas
Sponsors
Leads: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

This content was sourced from clinicaltrials.gov

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