Best Systemic Therapy or Best Systemic Therapy (BST) Plus Definitive Treatment (Radiation or Surgery)
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)
2 other identifiers
interventional
180
2 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Mar 2013
Longer than P75 for phase_2 prostate-cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2012
CompletedFirst Posted
Study publicly available on registry
December 18, 2012
CompletedStudy Start
First participant enrolled
March 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2023
CompletedApril 27, 2023
April 1, 2023
10.1 years
December 14, 2012
April 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival
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.
60 days
Study Arms (2)
Best Systemic Therapy (BST)
EXPERIMENTALGroup 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.
Best Systemic Therapy (BST) + Surgery or Radiation Therapy
EXPERIMENTALGroup 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.
Interventions
Group 1 will continue to receive best systemic therapy (BST).
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.
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.
Eligibility Criteria
You may qualify if:
- Male patients
- 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
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
UCSF University of California
San Francisco, California, 94143, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Vancouver Prostate Center
Vancouver, British Columbia, V5Z 1M9, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian F. Chapin, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2012
First Posted
December 18, 2012
Study Start
March 18, 2013
Primary Completion
April 19, 2023
Study Completion
April 19, 2023
Last Updated
April 27, 2023
Record last verified: 2023-04