Best Systemic Therapy or Best Systemic Therapy (BST) Plus Definitive Treatment (Radiation or Surgery)
This study is currently recruiting participants.
Verified March 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01751438
First received: December 14, 2012
Last updated: March 18, 2013
Last verified: March 2013
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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:
- Male patients
- 18 yrs and older
- Histologically or cytologically proven prostate carcinoma
- Documented evidence of M1 disease by AJCC (American Joint Committee on Cancer) staging by Bone scan, CT and/or MRI.
- Androgen dependent disease measured by declining PSA and do not display signs of progression demonstrated by a rising PSA.
- Treatment initiation with BST no longer than 6 months prior to randomization
- ECOG PS 0 or 1
- Life-expectancy based on comorbid conditions >2 years
- Ability to understand and willingness to sign informed consent
- Must be a candidate for surgery and/or radiation therapy
Exclusion Criteria:
- Psychiatric or medical conditions which, in the opinion of the treating physician, would not allow the patient to undergo the proposed treatments safely.
- Known brain metastasis
- Small cell carcinoma of the prostate
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751438
Contacts
| Contact: Ana M. Aparicio, MD | 713-792-3250 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Ana M. Aparicio, MD | UT MD 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 |
| Study First Received: | December 14, 2012 |
| Last Updated: | March 18, 2013 |
| 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 May 19, 2013