Cytoreductive Prostatectomy in Treating Patients With Newly Diagnosed, Metastatic Prostate Cancer

Metastatic Prostate Carcinoma Clinical Trial

Official title:

Feasibility of Cytoreductive Prostatectomy in Men Newly Diagnosed With Metastatic Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02458716
• Other study ID #: Pro20140001022
• Secondary ID: NCI-2015-00384Pr
• Status: Completed
• Phase: Phase 1
• Start date: March 6, 2015
• Est. completion date: January 14, 2020

Study information

• Verified date: April 2021
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase I trial studies the side effects of cytoreductive prostatectomy in treating patients with newly diagnosed prostate cancer that has spread from the primary site to other places in the body. Cytoreductive prostatectomy is a type of surgery that removes the prostate and as much of the tumor as possible. When combined with hormone therapy, robotic assisted radical prostatectomy (RARP) or conventional open retropubic radical prostatectomy (RRP) may prolong survival in patients with prostate cancer that has spread.

Description:

PRIMARY OBJECTIVES:

I. To determine the safety and feasibility of cytoreductive prostatectomy (to remove as much of the primary cancer as possible) in men with newly diagnosed clinical T1-3N1M0 or T1-3N0M1a-b prostate cancer (herein, collectively referred to as metastatic prostate cancer).

SECONDARY OBJECTIVES:

I. Time to prostate specific antigen (PSA) nadir and castration resistance following cytoreductive prostatectomy and subsequent standard systemic therapy, androgen deprivation.

OUTLINE:

Patients undergo RARP or conventional open RRP. Immediately following surgery, patients receive standard systemic androgen deprivation therapy.

After completion of study treatment, patients are followed up every 90 days for 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 14, 2020
• Est. primary completion date: January 14, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically proven adenocarcinoma of the prostate

• Evidence of lymph node or bone metastasis by magnetic resonance imaging (MRI)/computed tomography (CT), bone scan, or biopsy (N1Mx or NxM1)

• Give informed consent

• Clinical stage T3 or less (pelvic MRI shows no rectal and ureteral invasion)

• Cleared by the primary medical doctor for surgery

• No prior systemic therapy for metastatic prostate cancer

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

• Refuses to give informed consent

• Refuses or is unable to have pelvic MRI

• Clinical stage T4 (pelvic MRI shows rectal and/or ureteral invasion)

• Deemed a poor surgical risk per primary medical doctor

• Received prior therapeutic intervention for metastatic prostate cancer

• Known spinal cord compression or brain or liver metastasis

• Deep vein thrombosis (DVT)/pulmonary embolism (PE) in the past 6 months

Related Conditions & MeSH terms

• Carcinoma
• Metastatic Prostate Carcinoma
• Metastatic Prostatic Adenocarcinoma
• Prostate Carcinoma Metastatic to the Bone
• Prostatic Neoplasms

Intervention

Procedure:
• Robotic Assisted Radical Prostatectomy
Undergo RARP
• Conventional open retropubic radical prostectomy
Undergo conventional open RRP

Other:
• Laboratory Biomarker Analysis
Correlative studies
• Quality-of-Life Assessment
Ancillary studies

Drug:
• ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)
LHRH agonist or antagonist (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)

Locations

Country	Name	City	State
United States	City of Hope National Medical Center (COH)	Duarte	California
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	University of California, Irvine (UCI)	Orange	California

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of major peri-operative complications defined as Clavien-Dindo grade III or higher	Rate will be calculated for the primary end point, and one-sided Binomial test will be used to compare the rate to the hypothesized value. Descriptive statistics will be provided. Any further statistical analysis deemed necessary to calculate significant findings will be done with the assistance of the Rutgers Cancer Institute of New Jersey Biostatistics Section.	Within 90 days after cytoreductive prostatectomy
Secondary	Time to PSA nadir	Time to event data will be analyzed using the Kaplan-Meier product limit method. Descriptive statistics will be provided. Any further statistical analysis deemed necessary to calculate significant findings will be done with the assistance of the Rutgers Cancer Institute of New Jersey Biostatistics Section.	Up to 3 years
Secondary	Time to rising PSA while on the standard androgen deprivation therapy	Time to event data will be analyzed using the Kaplan-Meier product limit method. Descriptive statistics will be provided. Any further statistical analysis deemed necessary to calculate significant findings will be done with the assistance of the Rutgers Cancer Institute of New Jersey Biostatistics Section.	Up to 3 years