Radiation and Androgen Ablation for Prostate Cancer (NCT01517451) | Clinical Trial Compass
CompletedPhase 1/2
Radiation and Androgen Ablation for Prostate Cancer
United States45 participantsStarted 2013-05-22
Plain-language summary
A study to see how effective and tolerable radiation therapy along with androgen deprivation therapy is in treating prostate cancer.
Who can participate
Age range18 Years – 100 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 …
What they're measuring
1
Biochemical Failure Free-rate (BFFR) Associated With the Combined Hypofractionated Dose Regimen and Androgen Deprivation Therapy (ADT).
Timeframe: From consent up to 5 years post treatment completion
Trial details
NCT IDNCT01517451
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins