Status:
UNKNOWN
HDR vs LDR Brachytherapy as Monotherapy in the Treatment of Localized Prostate Cancer.
Lead Sponsor:
National Institute of Oncology, Hungary
Conditions:
Adenocarcinoma of Prostate
Eligibility:
MALE
40-75 years
Phase:
PHASE2
PHASE3
Brief Summary
Investigators compare in a randomized clinical trial the results and side effects of high-dose- and low-dose-rate brachytherapy as monotherapy in the treatment of early, organ confined prostate cancer...
Detailed Description
Permanent implant prostate brachytherapy (LDRPBT) is a well established and proved method in the treatment of patients with low or selected intermediate risk, organ confined prostate cancer. There ar...
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group (ECOG) status \<=1
- 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
- \<40 years or \>75 years old
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02258087
Start Date
September 1 2014
End Date
September 1 2019
Last Update
October 7 2014
Active Locations (1)
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1
Peter Agoston
Budapest, Hungary, 1122