Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brach… (NCT01982786) | Clinical Trial Compass
CompletedNot Applicable
Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brachytherapy Boost In Men With Intermediate-Risk Prostate Cancer
Canada57 participantsStarted 2014-04-22
Plain-language summary
This research is being done because investigators involved in this study would like to compare image guided external beam radiation therapy (IGRT) to IGRT plus HDR brachytherapy boost to see which treatment is better and what the side effects of treatment are.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed prostate adenocarcinoma. The date of the last biopsy that verifies that the eligibility criterions have been met must be within 9 months prior to randomization. There must be no prior treatment.
* Intermediate-risk cancer patients based on the NCCN Guidelines (www.nccn.org):
• TNM classification:
* T2b-T2c and Gleason Score \< 8/10 and PSA \< 20 ng/ml; or
* T1c-T2a and Gleason Score 7/10 and PSA \< 20 ng/ml; or
* T1c-T2a and Gleason Score ≤ 6/10 and 10 ≤ PSA \< 20 ng/ml
For patients who have been on alpha reductase inhibitors within the last 6 months, use the following guidelines:
* T2b-T2c and Gleason Score \< 8/10 and PSA ≤ 10 ng/ml; or
* T1c-T2a and Gleason Score 7/10 and PSA ≤ 10 ng/ml; or
* T1c-T2a and Gleason Score ≤ 6/10 and 5 ≤ PSA ≤ 10 ng/ml
* No alpha reductase inhibitors (i.e. avodart, proscar) use within 2 weeks of randomization. A washout period of 2 weeks is required prior to randomization.
* Prostate volume ≤ 75 cc.
* American Urological Association (AUA) Symptom Index score \< 20.
* Judged to be medically fit for IGRT and HDR brachytherapy boost by a radiation oncologist.
* ECOG Performance Status of 0 or 1.
* ≥ 18 years of age.
* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate.
* Patients must be accessible for treatment and follow…