HDR vs LDR Brachytherapy as Monotherapy in the Treatment of Localized Prostate Cancer.

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    National Institute of Oncology, Hungary
Updated on 8 November 2020
cancer
prostate specific antigen
brachytherapy

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 patients.

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 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.

Details
Condition Adenocarcinoma of Prostate
Treatment HDR Brachytherapy, LDR Brachytherapy
Clinical Study IdentifierNCT02258087
SponsorNational Institute of Oncology, Hungary
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) status <=1
-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
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