Clinical trial NCT03456843: Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer
Official title: SIMCAP (Surgery in Metastatic Carcinoma of Prostate): Phase 2.5 Multi-Institution Randomized Prospective Clinical Trial Evaluating the Impact of Cytoreductive Radical Prostatectomy Combined With Best Systemic Therapy on Oncologic and Quality of Life Outcomes in Men With Newly Diagnosed Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Stage IV Prostate Adenocarcinoma AJCC v7
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-03-07
Enrollment: 190
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized phase II trial studies how well surgical removal of the prostate and antiandrogen therapy with or without docetaxel work in treating men with newly diagnosed prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Antiandrogen therapy may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Surgery, antiandrogen therapy and docetaxel may work better in treating participants with prostate cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To assess the clinical benefit of combining radical surgery cytoreductive radical prostatectomy (CRP) - with the best systemic therapy (BST) in men with newly diagnosed clinical metastatic prostate cancer (mPCa).

SECONDARY OBJECTIVES:

I. To determine the impact of CRP+BST on time to biochemical progression, cancer-specific survival, complication rates, and quality of life (QOL) in patients with mPCa.

II. To determine the transcription levels of bone morphogenetic protein -6 (BMP-6) and transforming growth factor-beta (TGF-?).

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive antiandrogen therapy with or without docetaxel at the discretion of the treating physician.

ARM II: Participants receive antiandrogen therapy for at least 1 month, then undergo cytoreductive radical prostatectomy. Participants continue antiandrogen therapy and may receive docetaxel prior to surgery at the discretion of the treating physician.

After completion of study treatment, patients are followed up every 6 months from time of progression.

Eligibility criteria: Inclusion Criteria:

* Histologically proven adenocarcinoma of the prostate
* Evidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmation
* Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (solid organ metastasis.
* If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET \[positron emission tomography\], bone scan and MRI, modality at the discretion of the treating physician)
* No previous local therapy for prostate cancer (i.e prostate radiation, cryotherapy, etc.)
* Give informed consent
* Prostate deemed resectable by surgeon
* Plans to start or has already started antiandrogen therapy (ADT) no longer than 6 months prior to consent
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Hemoglobin (HgB) \>= 9 g/dL compatible for surgery
* Platelets \> 80,000/mcL compatible for surgery
* Aspartate aminotransferase (AST) =\< 2x upper limit of normal (ULN) compatible for surgery
* Alanine aminotransferase (ALT) =\< 2x upper limit of normal (ULN) compatible for surgery

Exclusion Criteria:

* Refuses to give informed consent
* Deemed to have unresectable disease by surgeon
* Received ADT for more than 6 months prior to consent
* Life expectancy of less than 6 months prior to consent
* Active spinal cord compression
* Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to consent
* Previous local therapy for prostate cancer
* Patients who have chemotherapy or radiotherapy for non-prostate cancer related treatment within 3 weeks prior to consent

Primary outcomes:
measure: Failure-free survival (FFS)
timeFrame: At 2 years
Secondary outcomes:
measure: Cancer-specific survival
timeFrame: Up to 2 years
measure: Overall complication rate
timeFrame: Up to 2 years
measure: Time to biochemical progression
timeFrame: Up to 2 years
measure: Overall survival
timeFrame: Through study completion, a minimum of 4 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Irvine
country: United States
facility: University of California
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Philadelphia
country: United States
facility: Unniversity of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Seattle
country: United States
facility: Swedish Medical Services
state: Washington
city: East Melbourne
country: Australia
facility: Epworth Healthcare
city: Hong Kong
country: China
facility: Chinese University of Hong Kong
city: Sako
country: Japan
facility: Kyoto University
state: Kyoto
city: Ōsaka-sayama
country: Japan
facility: Kindai University
state: Osaka
city: Akita
country: Japan
facility: Akita University
city: Tokyo
country: Japan
facility: Juntendo University
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Yale University
name: Isaac Kim
role: PRINCIPAL_INVESTIGATOR
References: