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

This study is currently recruiting participants.
Verified March 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01751438
First received: December 14, 2012
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

The goal of this clinical research study is to learn if treatment with standard systemic therapy 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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Progression-Free Survival [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 120
Study Start Date: March 2013
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751438

Contacts
Contact: Brian F. Chapin, MD 713-792-3250

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Brian F. Chapin, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01751438     History of Changes
Other Study ID Numbers: 2012-0705, NCI-2013-00415
Study First Received: December 14, 2012
Last Updated: March 6, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014