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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2022
  • participants needed
    190
  • sponsor
    Rutgers, The State University of New Jersey
Updated on 26 January 2021

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.

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.

Details
Condition Stage IV Prostate Adenocarcinoma AJCC v7
Treatment laboratory biomarker analysis, questionnaire administration, quality-of-life assessment, docetaxel, antiandrogen therapy, Radical Prostatectomy
Clinical Study IdentifierNCT03456843
SponsorRutgers, The State University of New Jersey
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have Stage IV Prostate Adenocarcinoma AJCC v7?
Do you have any of these conditions: Do you have Stage IV Prostate Adenocarcinoma AJCC v7??
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
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