HDR vs LDR Brachytherapy as Monotherapy in the Treatment of Localized Prostate Cancer.
NCT ID: NCT02258087
Last Updated: 2014-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
50 participants
INTERVENTIONAL
2014-09-30
2019-09-30
Brief Summary
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Detailed Description
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There are number of studies with high-dose rate brachytherapy (HDRPBT) as monotherapy with several fractionation schedule treating the same group of patients. One phase II trial showed its effectiveness given in one fraction of 19 Gy.
In the trial investigators randomly select patients to treat with either LDR prostate brachytherapy (145Gy) or HDR prostate brachytherapy (1x19Gy) as monotherapy.
Patients are stratified into two pretreatment group: 1. low risk, 2. selected intermediate risk group.
Brachytherapy is given in spinal anaesthesia, using transrectal ultrasound based real time treatment planning. Dose constraints are defined for both methods.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LDRPBT
Patients with low and selected intermediate risk prostate cancer are treated with Prostate LDR brachytherapy as monotherapy. 145 Gy is prescribed to the prostate. I-125 radioactive sources are used. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time dose optimization is applied.
LDR Brachytherapy
In spinal anaesthesia patients' prostate are treated with low-dose-rate or brachytherapy using transrectal ultrasound guidance. Radiation sources (iodine-125 isotopes) are implanted into the prostate through transperineal needle insertion. Real time dose planning is applied. The prescribed dose to the whole prostate is 145 Gy.
HDRPBT
Patients with low and selected intermediate risk prostate cancer are treated with prostate HDR brachytherapy as monotherapy. The prescribed dose is 1x19 Gy to the whole prostate. Ir-192 radioactive source is used. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time dose optimization is applied.
HDR Brachytherapy
In spinal anaesthesia patients' prostate are treated with one fraction of HDR brachytherapy. The prescribed dose to the whole prostate is 1x19 Gy. Ir-192 radioactive stepping source is used for the treatment with after-loading technique. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time intraoperative needle position update and dose optimization is applied.
Interventions
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LDR Brachytherapy
In spinal anaesthesia patients' prostate are treated with low-dose-rate or brachytherapy using transrectal ultrasound guidance. Radiation sources (iodine-125 isotopes) are implanted into the prostate through transperineal needle insertion. Real time dose planning is applied. The prescribed dose to the whole prostate is 145 Gy.
HDR Brachytherapy
In spinal anaesthesia patients' prostate are treated with one fraction of HDR brachytherapy. The prescribed dose to the whole prostate is 1x19 Gy. Ir-192 radioactive stepping source is used for the treatment with after-loading technique. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time intraoperative needle position update and dose optimization is applied.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 40-75 years old
* expected life expectancy\>10 years
* low risk prostate cancer (Prostate specific antigen (PSA)\<=10ng/ml, gleason score \<7, T status\<=2a), less than 50 % positive biopsy cores
* selected intermediate prostate cancer (PSA)=10-\<15ng/ml or gleason score =3+4(but not 4+3), or T2b-c, less than 50 % positive biopsy cores)
* International prostate symptom score (IPSS) \<=15
* Prostate volume\<=50cm3
* no pubic interference
* no prior prostate operation, except biopsy
* no prior radiation to pelvis
* patient signed the informed consent
Exclusion Criteria
* PSA\>15 ng/ml gleason score 4+3 , score 8-10
* ECOG\>=2
* T3-4
* percent core positivity \>50 %
* TUR operation within six months prior to the brachytherapy prostate volume\<10 cm3 or \>50 cm3 IPSS \>15
40 Years
75 Years
MALE
No
Sponsors
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National Institute of Oncology, Hungary
OTHER
Responsible Party
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Peter Agoston
MD, PhD
Principal Investigators
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Peter Agoston, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
NIO, Hungary
Locations
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Peter Agoston
Budapest, , Hungary
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PROMOBRA-2013
Identifier Type: -
Identifier Source: org_study_id
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