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 range
18 Years – 100 Years
Sex
MALE
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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