carcinoma of the prostate prostate cancer
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age of 18 years or older - WHO performance score 0-2 - Biopsy proven adenocarcinoma of the prostate - Gleason * 6 - Prostate volume * 90 cc on TRUS - T-stage: cT1c-T3b (on MRI and/or endorectal ultrasound) - All patients should be able to undergo MRI scans - No evidence of lymph node or distant metastases on radiological staging - The multidisciplinary team advised external beam radiotherapy treatment - IPSS (International Prostate Symptoms Score) *19 - Previous TURP is allowed provided there is at least 8 weeks interval with radiotherapy - The administration of concomitant hormonal therapy is allowed - Ability to provide written informed consent -
Exclusion criteria
Exclusion criteria: - Previous irradiation in the pelvic region - Contra-indications for MRI (see appendix X)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objective of this phase II observational study is to investigate the early and early-delayed toxicity, special attention for GI symptoms, GU symptoms and sexual symptoms, that is observed in the first year following treatment at 6 weeks, 3, 6, 9 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this study will be to investigate the dosimetric benefit of the adaptive part of SMART in patients with localized prostate cancer. Also Quality of life (QoL) will be monitored using the EORTC QoL core questionnaire (QLQ-C30) in combination with the QLQ Prostate Cancer module (QLQ-PR25). | — |
Countries
Netherlands
Outcome results
None listed