Lay Title: Systemic and directed therapy for recurrent prostate cancer
Technical Title: A Single-Arm, Open-Label, Phase II Study of Systemic and Tumor Directed Therapy for Recurrent Oligometastatic M1 Prostate Cancer
Disease Type: Recurrent metastatic prostate cancer after radical prostatectomy with 1-5 metastasis
Basic information: The purpose of this study is to find out what effects, good and/or bad, combined, directed, systemic therapies have on patients with recurrent prostate cancer which has spread in a limited way. Systemic therapy refers to drugs. Metastasis-directed therapy refers to radiation of the areas where the cancer has spread, and sometimes also to the area in the pelvis where the prostate was located. Additionally, researchers will examine the genes of subjects like you to discover whether there is a way to predict how someone might respond to this treatment.
Research Procedures (not a complete list): If you take part in this study, you will start Androgen Deprivation Therapy (ADT) consisting of leuprolide, apalutamide (experimental) and abiraterone acetate plus prednisone by mouth. ADT reduces the levels of hormones such as testosterone to prevent the cancer cells from growing. You will be on ADT for 6 months. It may take an additional few months for the effects of the ADT to wear off. You will be seen by your regular doctors monthly while on ADT. At these visits you will have a brief physical exam, provide blood for routine laboratory tests, provide urine for routine laboratory tests, and up to about 8 teaspoons of blood drawn for the purposes of this research. You will receive Stereotactic Body Radiation Therapy (SBRT) within two months of initiation of ADT. Radiation will be given in 1 to 5 separate “fractions” or treatments, over about 1-2 weeks.
If you have not previously received radiotherapy directed to the pelvis after surgery, you will have the option of receiving fractionated Intensity-modulated radiation therapy (IMRT). This pelvic radiation can be completed during or after ADT. You will receive up to 60 separate fractions over a period of about two months, depending upon what your doctor recommends.
You will return to clinic for a follow-up visit approximately every 30 days for the first 6 months and then approximately every 3 months thereafter for up to 2 years following completion of your treatment. At these follow up visits you will have a brief physical exam including vital signs, review any changes to your health, and blood and urine will be collected for routine laboratory tests. When the trial is done, you will continue to receive standard medical care.
Eligibility Criteria (not a complete list):
For More Detailed Information, Contact: