Prostate Cancer Clinical Trial
— BRAPROSTOfficial title:
Phase II Study of Dose Escalation to Dominant Intraprostatic Lesions (DIL) With MRI-TRUS Fusion Real Time High Dose Rate (HDR) Brachytherapy in Patients With Intermediate and High Risk Prostate Cancer
The Magnetic Resonance (MR) provides high resolution of soft tissue images allowing an
appropriate assessment of the local extent of the disease. Recent studies have shown an
increase in sensitivity and specificity for the detection of Dominant intraprostatic lesions
when using multiparametric MRI as a diagnostic tool in the staging of the disease.
Among the various irradiation techniques currently available for prostate cancer,
Brachytherapy is the superior in terms of dose conformation; this conformation allows
greater dose escalation, adjusting the isodoses to the prostate with exquisite accuracy,
keeping healthy adjacent organs, such as the urethra and rectum, in a tolerable dose range
Brachytherapy companies have recently developed software allowing for TRUS-MR image fusion.
The purpose of this study is to demonstrate the feasibility of the delivery of a higher than
prescription dose to the dominant intra-prostatic nodule as defined on multiparametric MRI.
Dose to prostate, and adjacent structure will remain the same as the current treatment
practice. Timing and the delivery of brachytherapy will not change from our current practice
Status | Recruiting |
Enrollment | 15 |
Est. completion date | July 2016 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Men =18 years - Histologically proven adenocarcinoma of the prostate - Intermediate or high risk prostate cancer Intermediate risk prostate cancer patients must have: Clinical stage = T2c, Gleason score = 7 and iPSA = 20, or Gleason score = 6 and iPSA > 10 and = 20. High risk patients may have Clinical stage T3 Gleason score 8-10 PSA > 20 ng/ml - A palpable nodule or a cluster of positive biopsies from a single region suggesting the presence of dominant nodule and with radiologic correlation by MRI. - Estimated life expectancy of at least 10 years. - ECOG performance status of 0 - 2. - Signature of informed conseny Exclusion Criteria: - Contraindications to interstitial prostate brachytherapy. - If on coumadin therapy and NOT able to stop safely for 7 days. - Does not have a localized high volume of intraprostatic disease and MRI contraindicated - Unfit for general anesthetic |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Cruces | Barakaldo | Bizkaia |
Lead Sponsor | Collaborator |
---|---|
Alfonso Gomez-Iturriaga | Hospital de Cruces |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of delivery higher than prescription doses (at least 125% of the dose)using inverse planned MRI-TRUS fusion high dose rate (HDR) brachytherapy. | Use the multiparametric MRI to identify dominant intraprostatic lesions (DIL) and deliver higher doses to these lesions with real time HDR brachytherapy. The procedure will be considered feasible if DIL is covered by the 125% of prescription dose while respecting tolerance doses of adjacent normal organs | 12 months | Yes |
Secondary | Acute toxicity and tolerability compared to the historic cohort of patients treated with standard HDR brachytherapy | Data to be collected: urinary retention rate, International Prostate Symptom Score over time, rectal toxicity and genitourinary toxicity | 24 months | Yes |
Secondary | Efficacy assessed by PSA, Multiparametric MRI and prostate biopsy | Patients will be followed with PSA at every follow-up; Multiparametric MRI: at 12 months and 30 months; and TRUS guided biopsy: at 30 months | 30 months | No |
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