BCCA Center for the Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
Location status: Recruiting
NCT Number: NCT03246802
A dose-response relationship for radiation in the management of prostate cancer is well established. Local recurrence of prostate cancer after external beam radiotherapy occurs in at least 40% of patients treated because of inability to deliver sufficient dose through external beam techniques. These patients respond well to re-irradiation using brachytherapy with about 50% of selected patients remaining free of recurrence 5 years after salvage. Advanced imaging using multiparametric Magnetic Resonance Imaging (mpMRI) allows identification of the site of recurrence, permitting partial prostate salvage brachytherapy. There is extensive literature on Low Dose Rate salvage brachytherapy but less on High Dose Rate.
Interested in participating?
Request Info45 year and older
Male
Interventional
Not applicable
Kelowna, British Columbia, V1Y 5L3, Canada
Location status: Recruiting
Appropriately selected patients with histologically documented recurrence 3 years or more after initial external beam radiotherapy will undergo mpMRI for identification of the site of recurrence. A planning transrectal ultrasound (TRUS) will be obtained for fusion with the mpMRI and transposition of the target volume (GTV=gross tumor volume). A margin of 4.5 cm will be added to the GTV to create a focal planning target volume (PTV). The margin may be cropped at the interface with critical organs. Two fractions of HDR brachytherapy will be delivered, each from a single implant, 2 weeks apart. Following treatment patients will be monitored for toxicity and quality of life using the Expanded Prostate cancer Index (EPIC) questionnaire as well as the International Prostate Symptom score. Efficacy will be evaluated by monitoring the Prostate Specific Antigen (PSA) and if PSA is rising during follow-up, PSMA PET will be ordered when clinically indicated..
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
temporary radioactive implant
Time frame: 3-60 months
Common Terminology Criteria for Adverse Events (CTCAE V4.0)
Time frame: 3-60 months
Expanded Prostate Cancer Index (EPIC)
Time frame: 3-60 months
International Prostate Symptom Score
Time frame: 0-3 months
Common Terminology Criteria for Adverse Events (CTCAE V4.0)
Time frame: 0-3 months
Expanded Prostate Cancer Index (EPIC)
Time frame: 0-3 months
International Prostate Symptoms Score
Time frame: 60 months
PSA < 0.4 ng/ml at 60 months
Time frame: 2 years
Number of participants with site of failure determined by PSMA PET Scan at the time of rising PSA.
Interested in participating?
Request InfoBritish Columbia Cancer Agency
Other
High Dose Rate Partial Prostate Brachytherapy as Salvage Treatment for Local Failures After Previous External Beam Radiotherapy
Acronym: SalvageHDR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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