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

NCT04992026 | Completed Phase 2

• 1 other identifier: IUNU-PC-108
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostatectomy; Oligometastatic Prostate Cancer; Abiraterone

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• rPFS (radiographic progression free survival)

  up to 2 years

• Time to castration resistance

  up to 2 years

• Time to PSA remission (≥50%) and time to PSA remission (≥90%)

  up to 2 years

• Time to new anti-cancer treatment

  up to 2 years

Study Arms (2)

ADT plus abiraterone + surgery

EXPERIMENTAL

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; Drug: 1.Abiraterone Acetate Tablets; Drug: Prednisone Acetate Tablets; Drug: Luteinizing Hormone-Releasing Hormone Analog

ADT plus abiraterone

ACTIVE COMPARATOR

Patients will be only treated with Androgen deprivation therapy + abiraterone acetate along with prednisone. Prostatectomy won't be performed.

Drug: 1.Abiraterone Acetate Tablets; Drug: Prednisone Acetate Tablets; Drug: Luteinizing Hormone-Releasing Hormone Analog

Interventions

robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection PROCEDURE

Robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection will be performed.

ADT plus abiraterone + surgery

1.Abiraterone Acetate Tablets DRUG

1000mg(4 tablets, 250mg per tablet) daily for 6 cycles

ADT plus abiraterone; ADT plus abiraterone + surgery

Prednisone Acetate Tablets DRUG

5 mg oral low dose prednisone taken along with Abiraterone Acetate Tablets

ADT plus abiraterone; ADT plus abiraterone + surgery

Luteinizing Hormone-Releasing Hormone Analog DRUG

Hypodermic injection of Luteinizing Hormone-Releasing Hormone Analog every 4 weeks including goserelin, leuprolide, triptorelin ect.

ADT plus abiraterone; ADT plus abiraterone + surgery

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead
• The Affiliated Hospital of Xuzhou Medical University: collaborator
• The First People's Hospital of Changzhou: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• Wuxi People's Hospital: collaborator
• The Affiliated Hospital of Nantong University: collaborator
• The Affiliated Hospital of Yangzhou University: collaborator

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Location

MeSH Terms

Interventions

Prednisone; Gonadotropin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Hongqian Guo, MD

  Nanjing Drum Tower Hospital, affiliated to medical school of Nanjing University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 5, 2021
• Study Start: January 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 2, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)