Stereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized, Adenocarcinoma of the Prostate
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
This research is being done to study the safety and effectiveness of higher than conventional daily doses of radiation therapy in people with localized prostate cancer. Laboratory research suggests that higher daily doses of radiation may result in better control of prostate cancer, while also allowing for shorter overall treatment courses. A standard treatment for people with localized prostate cancer is radiation therapy given over 35 to40 days(approximately 8 weeks). The radiation therapy is often delivered with multiple beams of radiation that focus on your prostate. This form of focused radiation therapy is called intensity modulated radiation therapy (IMRT). We want to see if giving people a higher dose of radiation per day for only 5 days over a 2 week period is safe and effective for this type of prostate cancer. This short form of radiation therapy is also very focused and is called stereotactic body radiation therapy (SBRT). Primary Objective: to assess 5-year biochemical failure free rate (BFFR) associated with the combined SBRT and adrogen deprivation therapy (ADT).
1. Histologically confirmed, locally confined adenocarcinoma of the prostate 2. Patient must fit D'Amico intermediate risk criteria by clinical stage (T2b-T2c), PSA (10-20 ng/mL), and/or Gleason score (Gleason 7). 3. The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer. 4. Signed study-specific consent form prior to registration. 5. Patient must be greater than 18 years of age.
This short form of radiation therapy (SBRT) given over two weeks has not been given to patients with your type of prostate cancer (intermediate risk), therefore we are not sure if this form of radiation will be as effective or safe as the standard IMRT given over 8 weeks. People with your type of prostate cancer also receive hormone ablation with IMRT. In this study, you will also receive hormone ablation (ADT) with the short course of radiation therapy (SBRT). It is important that you know that standard radiation therapy is very effective at controlling your prostate cancer with approximately 80% of patients having control ten years after IMRT and hormone ablation. We do not know if this short course of radiation therapy with hormone abalation will be better or worse than standard treatment. People with prostate cancer who have chosen to have external beam radiation as part of their standard clinical care may join. Once you have completed your pre-study assessments you will begin your androgen deprivation therapy. ADT is made up of two drugs, an LHRH agonist which prevents your testicles from producing testosterone and bicalutamide which blocks the effects of any remaining testosterone made from other organs in your body. You will take the LHRH agonist for 4 months (beginning greater than or equal to 1 month prior to the start of SBRT). You will take bicalutamide for at least two weeks before radiation therapy; your doctor may ask you to take it during radiation if they think you may need it. After taking the ADT for 1 month or more you will begin your stereotactic radiation therapy (SBRT). The SBRT that you will be getting as part of this study is different from the intensity modulated radiation therapy (IMRT) that you would get if you did not participate in this study. Usually patients with your type of prostate cancer receive 8 weeks (Monday ï¿½ Friday) of IMRT. However, if you decide to participate in this study you will receive 2 weeks (5 days given every other day) of SBRT. The daily amount of radiation that you will receive if you participate in this study will be higher (7.25 Gy) than the daily amount of radiation you would receive if you received IMRT (1.8 ï¿½ 2.0 Gy) off this study. But the total amount of radiation you will receive if you participate in this study (36.25 Gy) is less than the total amount of radiation you would receive if you received IMRT (78-80 Gy) off of this study.
07/27/2016 05:03 AM