Ignite Creation Date:
2024-05-06 @ 1:13 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01751438
Status:
COMPLETED
Last Update Posted:
2023-04-27
First Post:
2012-12-14
Brief Title:
Best Systemic Therapy or Best Systemic Therapy BST Plus Definitive Treatment Radiation or Surgery
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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 CTMRI 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 doctors 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 callsemails 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 andor 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 CTMRI 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 andor 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
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 andor 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 CTMRI 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 doctors 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 callsemails 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 andor 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 CTMRI 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2013-00415 | REGISTRY | NCI CTRP | None |