Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total.
Age
18–100
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed, locally confined adenocarcinoma of the prostate
Patient must fit D'Amico intermediate risk criteria by clinical stage (T2b-T2c), PSA (prostatic specific antigen) (10-20 ng/mL), and/or Gleason score (Gleason 7).
The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer.
Signed study-specific consent form prior to registration
You may not be if
Stage T3-4 disease.
Gleason 8 or higher score.
PSA \> 20 ng/ml.
IPSS (International Prostate Symptom Score) \> 15
Clinical or Pathological Lymph node involvement (N1).
Evidence of distant metastases (M1).
Radical surgery for carcinoma of the prostate.
Previous Chemotherapy, unless intervention was greater than 5 years from beginning treatment for current prostate cancer.
Previous pelvic radiation therapy.
Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years.
History of inflammatory bowel disease.
Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.
Myocardial infarction or cerebrovascular accident within one year from consultation, or other major vascular risk factor which would prevent a patient from receiving appropriate androgen deprivation therapy.11
Liver function tests (LFTs) greater than twice the upper limit of normal.
