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

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

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

Study Overview

• Status: Completed
• Conditions: Prostatectomy; Oligometastatic Prostate Cancer; Abiraterone
• Intervention / Treatment: Procedure: robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection; Drug: 1.Abiraterone Acetate Tablets; Drug: Prednisone Acetate Tablets; Drug: Luteinizing Hormone-Releasing Hormone Analog

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADT plus abiraterone + surgery; After 6 cycles of first-line treatment (Androgen deprivation therapy + abiraterone acetate along with prednisone) , patients will receive robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection (ePLND) within 9 months of being diagnosed. The ADT+abiraterone treatment will be maintained after surgery.	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; Drug: Prednisone Acetate Tablets; 5 mg oral low dose prednisone taken along with Abiraterone Acetate Tablets; Drug: Luteinizing Hormone-Releasing Hormone Analog; Hypodermic injection of Luteinizing Hormone-Releasing Hormone Analog every 4 weeks including goserelin, leuprolide, triptorelin ect.
Active Comparator: ADT plus abiraterone; Patients will be only treated with Androgen deprivation therapy + abiraterone acetate along with prednisone. Prostatectomy won't be performed.	Drug: 1.Abiraterone Acetate Tablets; 1000mg(4 tablets, 250mg per tablet) daily for 6 cycles; Drug: Prednisone Acetate Tablets; 5 mg oral low dose prednisone taken along with Abiraterone Acetate Tablets; Drug: Luteinizing Hormone-Releasing Hormone Analog; Hypodermic injection of Luteinizing Hormone-Releasing Hormone Analog every 4 weeks including goserelin, leuprolide, triptorelin ect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
rPFS (radiographic progression free survival)	The time of radiographic progression free survival	up to 2 years
Time to castration resistance	The time to castration resistance	up to 2 years
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
Time to new anti-cancer treatment	Time to the point when onther anti-cancer treatment is necessary	up to 2 years

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Collaborators: The First Affiliated Hospital of Soochow University; The Affiliated Hospital of Xuzhou Medical University; Wuxi People's Hospital; The First People's Hospital of Changzhou; The Affiliated Hospital of Nantong University; The Affiliated Hospital of Yangzhou University
• Investigators: Principal Investigator: Hongqian Guo, MD, Nanjing Drum Tower Hospital, affiliated to medical school of Nanjing University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): December 2, 2024

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Glucocorticoids; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Enzyme Inhibitors; Steroid Synthesis Inhibitors; Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Abiraterone Acetate; Prednisone; Hormones; Prolactin Release-Inhibiting Factors
• Other Study ID Numbers: IUNU-PC-108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No