Comparison of High-dose- Versus Low-dose-rate Brachytherapy as Monotherapy in the Treatment of Early, Organ Confined Prostate Cancer.


Condition: Adenocarcinoma of Prostate

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02258087

Sponsor: National Institute of Oncology, Hungary

Phase: Phase 2/Phase 3

Eligibility:

  • Age: minimum 40 Years maximum 75 Years
  • Gender: Male

Inclusion Criteria:

  • 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 Criteria:

  • <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

View trial on ClinicalTrials.gov