a study on Prostate Cancer
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.
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)
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 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.
Within 60 days after screening:
Every 12 weeks (+/- 14 days) while on study (starting at month 9):
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).
Within 14 days after your study treatment is stopped, the following tests and procedures will be performed:
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.
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
Open to males ages 18 years and up
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT01751438.
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