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



Status:Recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/28/2019
Start Date:March 14, 2018
End Date:September 1, 2022

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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

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.

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 M1a or M1b 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 within 3 months after surgery at the discretion of the treating physician.

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

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), or M1b (bone 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

- Give informed consent

- Prostate deemed resectable by surgeon

- Started antiandrogen therapy (ADT) no longer than 6 months prior to randomization

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

- Hemoglobin (HgB) >= 9 g/dL compatible for surgery

- Platelets > 80,000 compatible for surgery

- Aspartate aminotransferase (AST)/ 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 randomization

- Life expectancy of less than 6 months prior to randomization

- Known spinal cord compression

- M1c disease (solid organ metastasis)

- Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to
randomization

- Previous local therapy for prostate cancer

- Previous chemotherapy for prostate cancer

- Patients who have chemotherapy, radiotherapy or oral antifungal agents (ketoconazole,
itraconazole, fluconazole) within 3 weeks prior to entering the study or those who
have not recovered (e.g. back to baseline or grade 1) from adverse events due to
agents administered more than 3 weeks earlier

- Any drug interactions that are deemed to be medically significant would require a
washout of 5-half-lives of the interaction agent before enrollment can occur
We found this trial at
2
sites
New Brunswick, New Jersey 08903
Principal Investigator: Isaac Y. Kim
Phone: 732-235-2043
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Edouard T. Trabulsi, MD
Phone: 215-955-1000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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