HDR vs LDR Brachytherapy as Monotherapy in the Treatment of Localized Prostate Cancer. (PROMOBRA)
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|ClinicalTrials.gov Identifier: NCT02258087|
Recruitment Status : Unknown
Verified October 2014 by Peter Agoston, National Institute of Oncology, Hungary.
Recruitment status was: Recruiting
First Posted : October 7, 2014
Last Update Posted : October 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of Prostate||Radiation: LDR Brachytherapy Radiation: HDR Brachytherapy||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of High-dose- Versus Low-dose-rate Brachytherapy as Monotherapy in the Treatment of Early, Organ Confined Prostate Cancer.|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2019|
Active Comparator: 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.
Radiation: 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.
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.
Radiation: 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 Name: temporary implant
- Acute side effects [ Time Frame: 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 [ Time Frame: 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
- quality of life [ Time Frame: 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).
- quality of life [ Time Frame: 5 years ]Assessing patients' quality of life according to the International Index for Erectile Function (IIEF) questionnaire
- Biochemical relapse free survival (bRFS) [ Time Frame: 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 [ Time Frame: 5 years ]Censoring an event when either local or regional relapse occurs
- Disease specific survival (DSS) [ Time Frame: 5 years ]Censoring an event when patient dies due to prostate cancer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258087
|Contact: Peter Agoston, MD PHD||+361 2248600 ext email@example.com|
|Contact: Csaba Polgar, MD, PHDfirstname.lastname@example.org|
|Principal Investigator:||Peter Agoston, MD, PHD||NIO, Hungary|