HDR Brachytherapy vs SABR in Early-intermediate Prostate Cancer

  • STATUS
    Recruiting
  • End date
    Apr 15, 2025
  • participants needed
    350
  • sponsor
    N.N. Petrov National Medical Research Center of Oncology
Updated on 15 May 2021

Summary

This is single center prospective phase 2 randomized trial aiming to compare biochemical and clinical relapse free survival and toxicity profiles of stereotactic body radiotherapy (SBRT) versus high dose rate brachytherapy (HDRB) for localized low- and intermediate risk prostate cancer patients.

Description

Before SBRT three fiducial markers are obligatory inserted into the prostate. Simulation and every SBRT sessions are performed after bowel preparation (enema) and bladder filling (400ml).Planning MRI on diagnostic table with subsequent fusing with simulation CT is obligatory. The clinical target volume (CTV) include the prostate only (low-risk patients) or prostate and proximal 1/3 of seminal vesicles (intermediate-risk patients). CTV to planning target volume (PTV) expansion was 3-5 mm in all direction except posteriorly (in the direction of the rectum) where it is 1-3 mm. Dose must be delivered as 5 fraction of 7.25Gy. V100% for PTV 95%. Main dose constraints are as follows: D 2cm 36Gy for rectum (below 75Gy EQD2)., V 37.5 Gy <5 cm for bladder, V 20 Gy <10 cm for femoral heads. Androgen deprivation therapy is not permitted.

All treatments must be performed on conventional linear accelerators with cone beam CT guidance before each fraction, intrafractional motion monitoring is optional.

After spinal anesthesia steel or plastic needle placement performed under TRUS guidance. Preand post-insertion ultrasound based planning is obligatory in all cases. Two fractions of 13Gy are delivered with 2 separate implantations and 2-3 weeks interval. The CTV was defined as the prostate capsule with 1mm (low-risk) - 3 mm (intermediate risk) expansion plus proximal 1/3 of seminal vesicles. The PTV was equal to CTV. The rectum, bladder and urethra are contoured as organs at risk. The dosimetry plan objectives are the following: prostate D90 - above 104% and V100% - above 92%; urethra D10 < 110% , rectum D2cc<75% (below 75Gy EQD2).

Patients are assessed during treatment, 4-12 weeks after the end of the treatment, every 3 months for the first year and then every 6 months till the end of the study. Normal tissue adverse events are reported according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0). International prostate symptoms score (IPSS) and international index of erectile function (IIEF-5) must be assessed on each visit, maximal urinary rate and residual urine volume - annually.

Details
Condition Biochemical Relapse Free Survival, Complications Rates (Erectile Dysfunction, GI, GU Complications), Complications Rates (Erectile Dysfunction, GI, GU Complications)
Treatment Stereotactic Ablative Radiotherapy, High dose rate brachytherapy
Clinical Study IdentifierNCT04870567
SponsorN.N. Petrov National Medical Research Center of Oncology
Last Modified on15 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

WHO performance status of 0-2
histologically confirmed prostate adenocarcinoma: Gleason score - 6-7 (4+3), clinical stage T1c-T2c, N0, M0
T and N stage determined by clinical examinations, MRI and/or PET-CT with PSMA
PSA below 20 ng/ml within the last 30 days
international prostate index score (IPSS) below 16
medically fit to spinal anesthesia
prostate volume below 110 cm
maximal urinary rate above 9 ml/sec, residual urine volume below 30ml
in the case of previous transurethral resection interval of at least 9 months after procedure

Exclusion Criteria

stage T3-T4
PSA > 20 ng/ml
clinically detected lymph node or distant metastases
previous pelvic irradiation
rectal surgery
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