Clinical Trial: NCT03456843 - My Cancer Genome

NCT03456843

Description:

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.

Related Conditions:

Prostate Adenocarcinoma

Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT03456843

Trial Eligibility

Document

Title

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

Clinical Trial IDs

ORG STUDY ID: Pro20170001506
SECONDARY ID: NCI-2018-00047
SECONDARY ID: 081707
SECONDARY ID: P30CA072720
NCT ID: NCT03456843

Conditions

Stage IV Prostate Adenocarcinoma AJCC v7

Interventions

Drug	Synonyms	Arms
Antiandrogen Therapy	ADT, Androgen Deprivation Therapy, Anti-androgen Therapy, Anti-androgen Treatment, Antiandrogen Treatment, Hormone Deprivation Therapy, Hormone-Deprivation Therapy	Arm I (ADT, docetaxel)
Docetaxel	Docecad, RP56976, Taxotere, Taxotere Injection Concentrate	Arm I (ADT, docetaxel)

Purpose

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.

Trial Arms

Name	Type	Description	Interventions
Arm I (ADT, docetaxel)	Experimental	Participants receive antiandrogen therapy with or without docetaxel at the discretion of the treating physician.	Antiandrogen Therapy Docetaxel
Arm II (ADT, radical prostatectomy, docetaxel)	Experimental	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.	Antiandrogen Therapy Docetaxel

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

          -  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

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	Male
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Failure-free survival (FFS)
Time Frame:	At 2 years
Safety Issue:
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.

Secondary Outcome Measures

Measure:	Cancer-specific survival
Time Frame:	Up to 2 years
Safety Issue:
Description:

Measure:	Overall complication rate
Time Frame:	Up to 2 years
Safety Issue:
Description:

Measure:	Time to biochemical progression
Time Frame:	Up to 2 years
Safety Issue:
Description:

Measure:	Overall survival
Time Frame:	Through study completion, a minimum of 4 years
Safety Issue:
Description:

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Rutgers, The State University of New Jersey

Last Updated

April 8, 2021

Clinical Trials /

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