Adenocarcinoma of Prostate
Conditions
Keywords
Prostate, Cancer, Brachytherapy, HDR, LDR, monotherapy
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 patients.
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 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.
Interventions
RADIATIONLDR 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.
RADIATIONHDR 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.
Sponsors
National Institute of Oncology, Hungary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute side effects | 6 months | Acute gastrointestinal, urogenital and other side effects occuring within six months after the procedure, according to the Common Toxicity Criteria for Adverse Effects (CTCAE 4.0v) scale |
| Chronic side effects | from 6 months to five year | Chronic gastrointestinal, urogenital and other side effects occuring within six months after the procedure, according to the CTCAE 4.0v scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quality of life | 5 years | Assessing patients' quality of life according to the a 25 question prostate module (PR-25) of the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QlQ-30). |
| Biochemical relapse free survival (bRFS) | 5 years | Censoring an event when biochemical relapse occurs using the American Society of Therapeutic Radiation and Oncology (ASTRO) Phoenix definition for PSA relapse (nadir + 2 ng/ml increase) |
| Locoregional tumor free survival | 5 years | Censoring an event when either local or regional relapse occurs |
| Disease specific survival (DSS) | 5 years | Censoring an event when patient dies due to prostate cancer |
Countries
Hungary
Contacts
Primary ContactPeter Agoston, MD PHD
Backup ContactCsaba Polgar, MD, PHD
Outcome results
None listed