Efficacy and Safety of Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer: A Prospective, Multi-centre 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 rezvilutamide in 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:

• 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 CT/MRI scan);

• 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 subjects are proposed to receive salvage radiation therapy, while arm 2 subjects are not suitable for or refuse radiation therapy.

⁃ Signed informed consent.

Locations
Other Locations
China
JiangSu Cancer Hospital
NOT_YET_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
+86-13605171690
Backup
Shun Zhang, MD
explorershun@126.com
+86-15050589789
Time Frame
Start Date: 2023-03
Estimated Completion Date: 2028-03
Participants
Target number of participants: 96
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
Experimental: Rezvilutamide +ADT
Rezvilutamide along with ADT for 12 cycles (28 days for each cycle)
Related Therapeutic Areas
Sponsors
Collaborators: Jiangsu HengRui Medicine Co., Ltd.
Leads: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

This content was sourced from clinicaltrials.gov

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