Prostate CancerPhase 2NCT01751438
Best Systemic Therapy or Best Systemic Therapy (BST) Plus Definitive Treatment (Radiation or Surgery)
A Phase 2 study testing Best Systemic Therapy (BST), Best Systemic Therapy (BST) + Surgery or Radiation Therapy and Questionnaires in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Best Systemic Therapy (BST), Best Systemic Therapy (BST) + Surgery or Radiation Therapy and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 18 Mar 2013to 19 Apr 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
UCSF University of California
San Francisco, California, 94143
About this study
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)
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.
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups at 6 months (+/- 14 days) from starting standard systemic therapy. You will have an equal chance of being assigned to each group.
- If you are in Group 1, you will continue to receive standard of care systemic treatment.
- If you are in Group 2, you will receive standard of care systemic treatment in addition to surgery to remove your prostate or radiation therapy to the prostate. You and your treating physician will decide if surgery or radiation therapy is the best choice for you. Your treating physician will explain the surgery or radiation therapy and their risks to you in more detail, and you will be asked to sign a separate consent form for the procedure.
If the disease gets worse within the first 6 months of receiving standard systemic therapy, you will not be assigned to a study group. You may be able to continue receiving standard systemic therapy if your doctor thinks it is in your best interest. You may choose to participate in this study by allowing the study team to collect information about you at the following study visits described below: within 60 days of screening, end-of-treatment, and long-term followup.
Study Visits:
Within 60 days after screening:
- You will have a physical exam, including a digital rectal exam (DRE).
- You will be asked how well you are able to perform the normal activities of daily living (performance status).
- Blood (about 2-3 teaspoons) will be drawn for routine tests, to check your prostate-specific antigen (PSA) levels, and testosterone levels.
- Urine will be collected for routine tests.
- You will complete a questionnaire about how you are feeling. It should take about 15 minutes to complete.
- You will have a bone scan, 2 CT scans of your abdomen and pelvis, and a chest X-ray or a computed tomography (CT) scan of chest to check the status of the disease.
- You will have a endorectal Magnetic Resonance Imaging (MRI) scan of the prostate to check the status of the disease.
Every 12 weeks (+/- 14 days) while on study (starting at month 9):
- You will have a physical exam, including a DRE and any updates to your medical history will be recorded.
- You will be asked about any side effects you may have had.
- You will be asked about any drugs or treatments you may be receiving, including over-the-counter drugs, herbal remedies, vitamins, and/or supplements.
- Blood (about 2-3 teaspoons) will be drawn for routine tests, to check your liver function, and to measure PSA and testosterone levels.
- You will complete a questionnaire about how you are feeling. It should take about 15 minutes to complete.
- If the study doctor thinks it is needed, you will have CT/MRI imaging scans to check the status of the disease.
If you are not having side effects after the 12-month visit, you will be given a PSA kit so you can send in a sample to test your PSA level. You will need to have your blood (about 1 teaspoon) drawn at your local doctor's office or lab and mail the kit in, every 3 months. The package will be provided, but you will need to pay postage. You would still need to visit the clinic every 6 months. The study staff will tell you more about this.
Length of Treatment:
You may continue your participation in this study for as long as the doctor thinks it is in your best interest. You will be taken off the study treatment if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your active participation on the study will be over after the long-term follow-up phone calls/emails (described below).
End-of-Treatment Visit:
Within 14 days after your study treatment is stopped, the following tests and procedures will be performed:
- You will have a physical exam, including a DRE.
- You will be asked about any side effects you may have had.
- You will be asked about any drugs or treatments you may be receiving, including over-the-counter drugs, herbal remedies, vitamins, and/or supplements.
- Blood (about 2-3 teaspoons) will be drawn for routine tests, to check your liver function, and to measure PSA and testosterone levels.
- Urine will be collected for biomarker testing.
- You will complete a questionnaire about how you are feeling. It should take about 15 minutes to complete.
- If the study doctor thinks it is needed, you will have CT/MRI imaging scans to check the status of the disease.
Long-Term Follow-Up:
Every 6 months after your end-of-treatment visit for up to 10 years, you will be contacted by phone or e-mail, and you will be asked questions about how you are feeling. Each phone call should last about 5 minutes. If you are not able to be contacted by phone or email, the study doctor will review and record any updates to your medical record.
This is an investigational study. Using standard of care systemic treatment with surgery, and/or radiation therapy are both FDA approved and commercially available.
Up to 180 patients will take part in this multi-center study. Up to 180 patients will be enrolled at MD Anderson.
- Conditions
- Prostate Cancer
- Being tested
- Best Systemic Therapy (BST), Best Systemic Therapy (BST) + Surgery or Radiation Therapy, Questionnaires, Phone Call/Email
- Keywords
- 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
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Systemic Therapy (BST)Other
Group 1 will continue to receive best systemic therapy (BST).
Best Systemic Therapy (BST) + Surgery or Radiation TherapyOther
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.
QuestionnairesBehavioural
Also called Surveys
Questionnaire completion at 60 days, 12 weeks, and at end of treatment visit. It should take about 15 minutes to complete.
Phone Call/EmailOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Best Systemic Therapy (BST) | Experimental | 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. Receives: Other: Best Systemic Therapy (BST); Behavioral: Questionnaires; Other: Phone Call/Email |
| Best Systemic Therapy (BST) + Surgery or Radiation Therapy | Experimental | 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. Receives: Other: Best Systemic Therapy (BST) + Surgery or Radiation Therapy; Behavioral: Questionnaires; Other: Phone Call/Email |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study start18 Mar 2013
- Primary completion19 Apr 2023
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian F. Chapin, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751438
- Sponsor's protocol ID
- 2012-0705
- Other IDs
- NCI-2013-00415
- Status last verified
- Apr 2023
- First submitted
- 14 Dec 2012
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01751438
- Acronym / sponsor ID
- 2012-0705
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Prostate carcinoma, Metastatic, M1, Best Systemic Therapy, BST, Androgen deprivation therapy, Bilateral orchiectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 18 Mar 2013 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 18 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups at 6 months (+/- 14 days) from starting standard systemic therapy. You will have an equal chance of being assigned to each group.
- If you are in Group 1, you will continue to receive standard of care systemic treatment.
- If you are in Group 2, you will receive standard of care systemic treatment in addition to surgery to remove your prostate or radiation therapy to the prostate. You and your treating physician will decide if surgery or radiation therapy is the best choice for you. Your treating physician will explain the surgery or radiation therapy and their risks to you in more detail, and you will be asked to sign a separate consent form for the procedure.
If the disease gets worse within the first 6 months of receiving standard systemic therapy, you will not be assigned to a study group. You may be able to continue receiving standard systemic therapy if your doctor thinks it is in your best interest. You may choose to participate in this study by allowing the study team to collect information about you at the following study visits described below: within 60 days of screening, end-of-treatment, and long-term followup.
Study Visits:
Within 60 days after screening:
- You will have a physical exam, including a digital rectal exam (DRE).
- You will be asked how well you are able to perform the normal activities of daily living (performance status).
- Blood (about 2-3 teaspoons) will be drawn for routine tests, to check your prostate-specific antigen (PSA) levels, and testosterone levels.
- Urine will be collected for routine tests.
- You will complete a questionnaire about how you are feeling. It should take about 15 minutes to complete.
- You will have a bone scan, 2 CT scans of your abdomen and pelvis, and a chest X-ray or a computed tomography (CT) scan of chest to check the status of the disease.
- You will have a endorectal Magnetic Resonance Imaging (MRI) scan of the prostate to check the status of the disease.
Every 12 weeks (+/- 14 days) while on study (starting at month 9):
- You will have a physical exam, including a DRE and any updates to your medical history will be recorded.
- You will be asked about any side effects you may have had.
- You will be asked about any drugs or treatments you may be receiving, including over-the-counter drugs, herbal remedies, vitamins, and/or supplements.
- Blood (about 2-3 teaspoons) will be drawn for routine tests, to check your liver function, and to measure PSA and testosterone levels.
- You will complete a questionnaire about how you are feeling. It should take about 15 minutes to complete.
- If the study doctor thinks it is needed, you will have CT/MRI imaging scans to check the status of the disease.
If you are not having side effects after the 12-month visit, you will be given a PSA kit so you can send in a sample to test your PSA level. You will need to have your blood (about 1 teaspoon) drawn at your local doctor's office or lab and mail the kit in, every 3 months. The package will be provided, but you will need to pay postage. You would still need to visit the clinic every 6 months. The study staff will tell you more about this.
Length of Treatment:
You may continue your participation in this study for as long as the doctor thinks it is in your best interest. You will be taken off the study treatment if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your active participation on the study will be over after the long-term follow-up phone calls/emails (described below).
End-of-Treatment Visit:
Within 14 days after your study treatment is stopped, the following tests and procedures will be performed:
- You will have a physical exam, including a DRE.
- You will be asked about any side effects you may have had.
- You will be asked about any drugs or treatments you may be receiving, including over-the-counter drugs, herbal remedies, vitamins, and/or supplements.
- Blood (about 2-3 teaspoons) will be drawn for routine tests, to check your liver function, and to measure PSA and testosterone levels.
- Urine will be collected for biomarker testing.
- You will complete a questionnaire about how you are feeling. It should take about 15 minutes to complete.
- If the study doctor thinks it is needed, you will have CT/MRI imaging scans to check the status of the disease.
Long-Term Follow-Up:
Every 6 months after your end-of-treatment visit for up to 10 years, you will be contacted by phone or e-mail, and you will be asked questions about how you are feeling. Each phone call should last about 5 minutes. If you are not able to be contacted by phone or email, the study doctor will review and record any updates to your medical record.
This is an investigational study. Using standard of care systemic treatment with surgery, and/or radiation therapy are both FDA approved and commercially available.
Up to 180 patients will take part in this multi-center study. Up to 180 patients will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best Systemic Therapy (BST) | Experimental | Other: Best Systemic Therapy (BST), Behavioral: Questionnaires, Other: Phone Call/EmailGroup 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 | Experimental | Other: Best Systemic Therapy (BST) + Surgery or Radiation Therapy, Behavioral: Questionnaires, Other: Phone Call/EmailGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best Systemic Therapy (BST)Group 1 will continue to receive best systemic therapy (BST). | Other | Best Systemic Therapy (BST) |
| Best Systemic Therapy (BST) + Surgery or Radiation TherapyGroup 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. | Other | Best Systemic Therapy (BST) + Surgery or Radiation Therapy |
| QuestionnairesAlso: SurveysQuestionnaire completion at 60 days, 12 weeks, and at end of treatment visit. It should take about 15 minutes to complete. | Behavioural | Best Systemic Therapy (BST), Best Systemic Therapy (BST) + Surgery or Radiation Therapy |
| Phone Call/EmailEvery 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), Best Systemic Therapy (BST) + Surgery or Radiation Therapy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian F. Chapin, MD principal investigator
M.D. Anderson Cancer Center
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Best Systemic Therapy (BST), Best Systemic Therapy (BST) + Surgery or Radiation Therapy and Questionnaires in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.