Clinical trial NCT02458716: Cytoreductive Prostatectomy in Treating Patients With Newly Diagnosed, Metastatic Prostate Cancer
Official title: Feasibility of Cytoreductive Prostatectomy in Men Newly Diagnosed With Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Prostate Carcinoma
Metastatic Prostatic Adenocarcinoma
Prostate Carcinoma Metastatic to the Bone
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Rutgers Cancer Institute of New Jersey
First posted: 2015-06-01
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of major peri-operative complications defined as Clavien-Dindo grade III or higher
timeFrame: Within 90 days after cytoreductive prostatectomy
Secondary outcomes:
measure: Time to PSA nadir
timeFrame: Up to 3 years
measure: Time to rising PSA while on the standard androgen deprivation therapy
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center (COH)
state: California
city: Orange
country: United States
facility: University of California, Irvine (UCI)
state: California
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Isaac Kim
role: PRINCIPAL_INVESTIGATOR
References: