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Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer

Primary Purpose

Stage IV Prostate Adenocarcinoma AJCC v7

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Antiandrogen Therapy
Docetaxel
Laboratory Biomarker Analysis
Quality-of-Life Assessment
Questionnaire Administration
Radical Prostatectomy
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IV Prostate Adenocarcinoma AJCC v7

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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
  • Known 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

Sites / Locations

  • City of HopeRecruiting
  • University of California
  • University of Southern CaliforniaRecruiting
  • Yale UniversityRecruiting
  • University of Chicago
  • University of Louisville
  • Rutgers Cancer Institute of New JerseyRecruiting
  • Unniversity of Pennsylvania
  • Thomas Jefferson University
  • Swedish Medical ServicesRecruiting
  • Epworth HealthcareRecruiting
  • Chinese University of Hong KongRecruiting
  • Kyoto University
  • Kindai UniversityRecruiting
  • Akita UniversityRecruiting
  • Juntendo UniversityRecruiting
  • National Cancer CenterRecruiting
  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (ADT, docetaxel)

Arm II (ADT, radical prostatectomy, docetaxel)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Failure-free survival (FFS)
Failure is defined as any one of the following events: PSA progression, clinical progression, radiographic progression, or death from prostate cancer. The % of men who fail within 2 years of randomization will be compare between the two groups using a one-sided log-rank test.

Secondary Outcome Measures

Cancer-specific survival
Overall complication rate
Time to biochemical progression
Overall survival

Full Information

First Posted
February 20, 2018
Last Updated
May 4, 2023
Sponsor
Yale University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03456843
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2018 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Prostate Adenocarcinoma AJCC v7

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (ADT, docetaxel)
Arm Type
Experimental
Arm Description
Participants receive antiandrogen therapy with or without docetaxel at the discretion of the treating physician.
Arm Title
Arm II (ADT, radical prostatectomy, docetaxel)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Antiandrogen Therapy
Other Intervention Name(s)
ADT, Androgen Deprivation Therapy, Anti-androgen Therapy, Anti-androgen Treatment, Antiandrogen Treatment, Hormone Deprivation Therapy, Hormone-Deprivation Therapy
Intervention Description
To demonstrate at least 30% improvement in FFS at 2 years after randomization with the power of 90% and error of 5% on a one-sided exponential MLE test.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Docecad, RP56976, Taxotere, Taxotere Injection Concentrate
Intervention Description
To demonstrate at least 30% improvement in FFS at 2 years after randomization with the power of 90% and error of 5% on a one-sided exponential MLE test.
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Radical Prostatectomy
Other Intervention Name(s)
Prostatovesiculectomy
Intervention Description
Undergo cytoreductive radical prostatectomy
Primary Outcome Measure Information:
Title
Failure-free survival (FFS)
Description
Failure is defined as any one of the following events: PSA progression, clinical progression, radiographic progression, or death from prostate cancer. The % of men who fail within 2 years of randomization will be compare between the two groups using a one-sided log-rank test.
Time Frame
At 2 years
Secondary Outcome Measure Information:
Title
Cancer-specific survival
Time Frame
Up to 2 years
Title
Overall complication rate
Time Frame
Up to 2 years
Title
Time to biochemical progression
Time Frame
Up to 2 years
Title
Overall survival
Time Frame
Through study completion, a minimum of 4 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isaac Kim
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Gozum
Phone
626-218-2490
Email
jgozum@coh.org
First Name & Middle Initial & Last Name & Degree
Bertram Yuh, MD
Facility Name
University of California
City
Irvine
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ileana Aldana
Phone
323-865-0702
Email
ileana.aldana@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Monish Aron, MD
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isaac Kim
Phone
203-200-4822
Email
isaac.kim@yale.edu
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Terminated
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Terminated
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Lee
Phone
732-867-9720
Email
kl1072@cinj.rutgers.edu
First Name & Middle Initial & Last Name & Degree
Saum Ghodoussipour, MD, PhD
Facility Name
Unniversity of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Terminated
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Terminated
Facility Name
Swedish Medical Services
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adel Islam
Phone
206-215-6532
Email
adel.islam@swedish.org
First Name & Middle Initial & Last Name & Degree
James R. Porter, MD
Facility Name
Epworth Healthcare
City
East Melbourne
ZIP/Postal Code
9084
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thilakavathi Chengodu
Phone
(03) 9936 6527
Email
Thili.chengodu@epworth.org.au
First Name & Middle Initial & Last Name & Degree
Nathan Lawrenrschuk, MD, PhD
Facility Name
Chinese University of Hong Kong
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Violet Yuen
Phone
852-3505-1663
Email
violetyuen@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Franco Lai
Phone
852-3505-1663
Email
francolai@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Chi-Fai Ng, MD
Facility Name
Kyoto University
City
Sako
State/Province
Kyoto
ZIP/Postal Code
606-8501
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Kindai University
City
Ōsaka-sayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ikuko Nakano
Phone
81-72-366-0221
Email
urology@med.kindai.ac.jp
First Name & Middle Initial & Last Name & Degree
Hirotsugu Uemura, MD, PhD
Facility Name
Akita University
City
Akita
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shintaro Narita
Phone
81188846156
Email
naritashintaro@gmail.com
First Name & Middle Initial & Last Name & Degree
Shintaro Narita, MD, PhD
Facility Name
Juntendo University
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masayoshi Nagata, MD, PhD
Phone
+81-3-5802-1227
Email
m-nagata@juntendo.ac.jp
First Name & Middle Initial & Last Name & Degree
Shigeo Horie, MD, PhD
Facility Name
National Cancer Center
City
Goyang-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Eun Kim
Phone
031-920-0943
Email
kje0917@ncc.re.kr
First Name & Middle Initial & Last Name & Degree
Jae Young Joung, MD, PhD
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mihee Chung
Phone
031 787 8355
Email
r1757@snubh.org
First Name & Middle Initial & Last Name & Degree
Seok-Soo Byun, MD

12. IPD Sharing Statement

Learn more about this trial

Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer

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