The Efficacy and Safety of Prostatectomy for Castration-Naive Oligometastatic Prostate Cancer

Prostatectomy Clinical Trial

Official title:

A Randomized, Controlled, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of Prostatectomy for Castration-Naive Oligometastatic Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04992026
• Other study ID #: IUNU-PC-108
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 1, 2021
• Est. completion date: May 1, 2025

Study information

• Verified date: August 2022
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized, controlled, multi-center clinical trial aims to evaluate the efficacy and safety of prostatectomy for castration-Naive oligometastatic prostate cancer

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: May 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients must be = 40 and =75 years of age.
• All patients must have a histologically or cytologically diagnosis of prostate cancer.
• All patients must have been diagnosed oligometastatic prostate cancer which meet the following criteria. (1) =5 metastatic lesions are found by imaging examination (2)No visceral metastasis was found (3) The diameter of a single lesion =5cm or the surface area =250cm2.
• Patients previously treated with surgical castration or androgen deprivation therapy must maintain a testosterone level of <50ng/dl or <1.7nmol/L during treatment. Also the treatment duration should be less than 9 months. Patients were previously treated with at least 6 cycles of abiraterone.
• PSA<2ng/ml before enrollment.
• There was no PSA progression or radiographic progression during previous treatment.
• Primary lesion must be eligible for radical prostatectomy based on random radiographic assessment. ( Preoperative clinical staging <T4 or achievable complete resection agreed by experienced surgeons is deemed as eligible for radical prostatectomy)
• Eastern Cooperative Oncology Group (ECOG) physical condition score = 1.
• Patients must have adequate hematologic function, within 28 days prior to registration as evidenced by: white blood cell (WBC) = 4.0 × 109 /L, platelets= 100 × 109 / L, hemoglobin = 9g / dL, and international normalized ratio (INR) < 1.5.
• Patients must have adequate hepatic function, within 28 days prior to registration, as evidenced by: total bilirubin (TBIL)=1.5 x upper limit of normal (ULN),and SGOT (AST) and SGPT (ALT) = 2.5 x ULN.
• Patients must have adequate renal function, within 28 days prior toregistration, as evidenced by serum creatinine =2×ULN
• Patients must participate voluntarily and sign an informed consent form(ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must be willing to obey the prohibitions and restrictions specified in the research protocol.

Exclusion Criteria:

• Patients with neuroendocrine, small cell, or signet ring cell histological features are not eligible.
• Patients with visceral metastasis or more than 5 metastatic lesions are excluded.
• Patients were diagnosed metastatic castration-naive prostate cancer for more than 9 months or showed biochemical or radiographic progression before enrollment.
• Patients with unresectable primary lesion before enrollment based on CT/MRI.
• Patients received local treatments such as pre-focal treatment, radiotherapy and palliative endoscopic resection.
• Patients with severe or uncontrolled concurrent infections are not eligible.
• Patients must not have New York Heart Association Class III or IV congestive heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months prior to registration.
• Patients must not have uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
• Patients must not have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.
• Patients with mental illness, mental disability or inability to give informed consent are not eligible.

Related Conditions & MeSH terms

• Oligometastatic Prostate Cancer
• Prostatectomy
• Prostatic Neoplasms

Intervention

Procedure:
• robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection
Robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection will be performed.

Drug:
• 1.Abiraterone Acetate Tablets
1000mg(4 tablets, 250mg per tablet) daily for 6 cycles
• Prednisone Acetate Tablets
5 mg oral low dose prednisone taken along with Abiraterone Acetate Tablets
• Luteinizing Hormone-Releasing Hormone Analog
Hypodermic injection of Luteinizing Hormone-Releasing Hormone Analog every 4 weeks including goserelin, leuprolide, triptorelin ect.

Locations

Country	Name	City	State
China	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (7)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	The Affiliated Hospital of Nantong University, The Affiliated Hospital of Xuzhou Medical University, The Affiliated Hospital of Yangzhou University, The First Affiliated Hospital of Soochow University, The First People's Hospital of Changzhou, Wuxi People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to PSA progression progression	PSA progression is defined as elevated PSA levels(=2ng/ml) for no less than 2 measurements at least 1 week apart.	up to 2 years
Primary	Time to Radiographic progression	Radiographic progression is defined as newly discovered soft tissue metastasis according to the RECIST 1.1 or at least 2 bone lesions.	up to 2 years
Secondary	rPFS (radiographic progression free survival)	The time of radiographic progression free survival	up to 2 years
Secondary	Time to castration resistance	The time to castration resistance	up to 2 years
Secondary	Time to PSA remission (=50%) and time to PSA remission (=90%)	Time to the point when PSA drop to below 50% initial PSA level. Time to the point when PSA drop to below 10% initial PSA level.	up to 2 years
Secondary	Time to new anti-cancer treatment	Time to the point when onther anti-cancer treatment is necessary	up to 2 years