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Best Systemic Therapy or Best Systemic Therapy (BST) Plus Definitive Treatment (Radiation or Surgery)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01751438
Recruitment Status : Active, not recruiting
First Posted : December 18, 2012
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The goal of this clinical research study is to learn if treatment with standard systemic therapy (androgen deprivation therapy or bilateral orchiectomy) in combination with surgery or radiation therapy is more effective at controlling prostate cancer than standard systemic therapy alone. The safety of this treatment combination will also be studied.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Best Systemic Therapy (BST) Other: Best Systemic Therapy (BST) + Surgery or Radiation Therapy Behavioral: Questionnaires Other: Phone Call/Email Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Institutional, Randomized, Phase II Trial of Best Systemic Therapy or Best Systemic Therapy (BST) Plus Definitive Treatment (Radiation or Surgery) of the Primary Tumor in Metastatic (M1) Prostate Cancer (PC)
Actual Study Start Date : March 18, 2013
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Best Systemic Therapy (BST)
Group 1 will continue to receive best systemic therapy (BST). Questionnaire completion at 60 days, 12 weeks, and at end of treatment visit. It should take about 15 minutes to complete. Every 6 months after end-of-treatment visit, patient contacted by phone or e-mail and asked questions about how they are feeling. Each phone call should last about 5 minutes.
Other: Best Systemic Therapy (BST)
Group 1 will continue to receive best systemic therapy (BST).
Behavioral: Questionnaires
Questionnaire completion at 60 days, 12 weeks, and at end of treatment visit. It should take about 15 minutes to complete.
Other Name: Surveys
Other: Phone Call/Email
Every 6 months after end-of-treatment visit, patient contacted by phone or e-mail and asked questions about how they are feeling. Each phone call should last about 5 minutes.
Experimental: Best Systemic Therapy (BST) + Surgery or Radiation Therapy
Group 2 will receive best systemic therapy (BST) in addition to surgery to remove prostate or radiation therapy to the prostate. Treating physician will decide if surgery or radiation therapy is the best choice. Questionnaire completion at 60 days, 12 weeks, and at end of treatment visit. It should take about 15 minutes to complete. Every 6 months after end-of-treatment visit, patient contacted by phone or e-mail and asked questions about how they are feeling. Each phone call should last about 5 minutes.
Other: Best Systemic Therapy (BST) + Surgery or Radiation Therapy
Group 2 will receive best systemic therapy in addition to surgery to remove prostate or radiation therapy to the prostate. Treating physician will decide if surgery or radiation therapy is the best choice.
Behavioral: Questionnaires
Questionnaire completion at 60 days, 12 weeks, and at end of treatment visit. It should take about 15 minutes to complete.
Other Name: Surveys
Other: Phone Call/Email
Every 6 months after end-of-treatment visit, patient contacted by phone or e-mail and asked questions about how they are feeling. Each phone call should last about 5 minutes.


Outcome Measures

Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 60 days ]
    Primary endpoint is progression-free survival, defined as the time interval from the start of initial best systemic therapy (BST) treatment to the date of disease progression or death, whichever occurred first.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male patients
  2. 18 yrs and older
  3. Histologically or cytologically proven prostate carcinoma
  4. Documented evidence of M1 disease by AJCC (American Joint Committee on Cancer) staging by Bone scan, CT and/or MRI.
  5. Androgen dependent disease measured by declining PSA and do not display signs of progression demonstrated by a rising PSA.
  6. Treatment initiation with BST no longer than 6 months prior to randomization
  7. ECOG PS 0 or 1
  8. Life-expectancy based on comorbid conditions >2 years
  9. Ability to understand and willingness to sign informed consent
  10. Must be a candidate for surgery and/or radiation therapy

Exclusion Criteria:

  1. Psychiatric or medical conditions which, in the opinion of the treating physician, would not allow the patient to undergo the proposed treatments safely.
  2. Known brain metastasis
  3. Small cell carcinoma of the prostate
  4. Any laboratory abnormalities, which in the opinion of the investigator, may put the subject at risk if participating in the study. For example: AST + ACT > 2 upper limits of normal value; WBC < 2.0; Hgb < 7.0.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751438


Locations
United States, California
UCSF University of California
San Francisco, California, United States, 94143
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Canada, British Columbia
Vancouver Prostate Center
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Brian F. Chapin, MD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01751438     History of Changes
Other Study ID Numbers: 2012-0705
NCI-2013-00415 ( Registry Identifier: NCI CTRP )
First Posted: December 18, 2012    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by M.D. Anderson Cancer Center:
Prostate cancer
Prostate carcinoma
Metastatic
M1
Best Systemic Therapy
BST
Androgen deprivation therapy
Bilateral orchiectomy
Radiation
Radiation Therapy
External beam radiation therapy
External-beam radiotherapy
Xray therapy
XRT
Surgery

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases