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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03456843




Registration number
NCT03456843
Ethics application status
Date submitted
20/02/2018
Date registered
7/03/2018
Date last updated
5/10/2020

Titles & IDs
Public title
Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer
Scientific 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
Secondary ID [1] 0 0
NCI-2018-00047
Secondary ID [2] 0 0
081707
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage IV Prostate Adenocarcinoma AJCC v7 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Antiandrogen Therapy
Treatment: Drugs - Docetaxel
Other interventions - Laboratory Biomarker Analysis
Treatment: Surgery - Quality-of-Life Assessment
Other interventions - Questionnaire Administration
Treatment: Surgery - Radical Prostatectomy

Experimental: Arm I (ADT, docetaxel) - Participants receive antiandrogen therapy with or without docetaxel at the discretion of the treating physician.

Experimental: Arm II (ADT, radical prostatectomy, docetaxel) - 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.


Treatment: Drugs: Antiandrogen Therapy
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.

Treatment: Drugs: Docetaxel
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.

Other interventions: Laboratory Biomarker Analysis
Correlative studies

Treatment: Surgery: Quality-of-Life Assessment
Ancillary studies

Other interventions: Questionnaire Administration
Ancillary studies

Treatment: Surgery: Radical Prostatectomy
Undergo cytoreductive radical prostatectomy

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Intervention code [3] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
At 2 years
Secondary outcome [1] 0 0
Cancer-specific survival
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
Overall complication rate
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
Time to biochemical progression
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
Overall survival
Timepoint [4] 0 0
Through study completion, a minimum of 4 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Epworth Healthcare - East Melbourne
Recruitment postcode(s) [1] 0 0
9084 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
China
State/province [7] 0 0
Hong Kong
Country [8] 0 0
Japan
State/province [8] 0 0
Kyoto
Country [9] 0 0
Japan
State/province [9] 0 0
Osaka

Funding & Sponsors
Primary sponsor type
Other
Name
Rutgers, The State University of New Jersey
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03456843
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Isaac Kim
Address 0 0
Rutgers Cancer Institute of New Jersey
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03456843