Best Systemic Therapy or Best Systemic Therapy (BST) Plus Definitive Treatment (Radiation or Surgery)
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ClinicalTrials.gov Identifier: NCT01751438 |
Recruitment Status :
Active, not recruiting
First Posted : December 18, 2012
Last Update Posted : December 7, 2022
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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 |

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 : | February 28, 2023 |
Estimated Study Completion Date : | February 28, 2023 |

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.
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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.
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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. |
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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
- 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.

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
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 |
Principal Investigator: | Brian F. Chapin, MD | M.D. Anderson Cancer Center |
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT01751438 |
Other Study ID Numbers: |
2012-0705 NCI-2013-00415 ( Registry Identifier: NCI CTRP ) |
First Posted: | December 18, 2012 Key Record Dates |
Last Update Posted: | December 7, 2022 |
Last Verified: | November 2022 |
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 |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |