Stereotactic MR-guided Adaptive Radiation Therapy (SMART) for localized prostate cancer; a phase II study
- Conditions
- carcinoma of the prostateprostate cancer10038364
- Registration Number
- NL-OMON42880
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
- 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
-
- Previous irradiation in the pelvic region
- Contra-indications for MRI (see appendix X)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main objective of this phase II observational study is to investigate the<br /><br>early and early-delayed toxicity, special attention for GI symptoms, GU<br /><br>symptoms and sexual symptoms, that is observed in the first year following<br /><br>treatment at 6 weeks, 3, 6, 9 and 12 months. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective of this study will be to investigate the dosimetric<br /><br>benefit of the adaptive part of SMART in patients with localized prostate<br /><br>cancer. Also Quality of life (QoL) will be monitored using the EORTC QoL core<br /><br>questionnaire (QLQ-C30) in combination with the QLQ Prostate Cancer module<br /><br>(QLQ-PR25).</p><br>