MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
- Conditions
- Prostate Cancer
- Interventions
- Radiation: MR-guided RT
- Registration Number
- NCT04896801
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- Brief Summary
The Proseven trial is a prospective interventional study that will evaluate the toxicity and efficacy of MR-guided stereotactic body radiotherapy (SBRT) in the profound hypofractionated treatment of prostate cancer. Patients will be treated in 5 daily fractions within a short overall treatment time (OTT) of 7 days. A simultaneous integrated boost (SIB) will be delivered to the intraprostatic dominant lesion (if present) in this study. Besides a potential biological impact of this innovative prostate SBRT treatment, the reduced OTT offers also benefits in terms of patient convenience. The primary endpoint is clinician reported grade 2 or more acute gastrointestinal (GI) and genitourinary (GU) toxicity, assessed using CTCAE v 5.0 and RTOG, measured up to 3 months after the first treatment fraction.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 132
- Age > 18 y
- Histologically confirmed prostate adenocarcinoma
- Low risk: cT1c-T2a, Gleason score 6, PSA < 10ng/mL
- Favorable intermediate risk: 1 intermediate risk factor, Gleason 3+4 or less, < 50% positive biopsy cores)
- Unfavorable intermediate risk: > 1 intermediate risk factor, Gleason 4+3, > 50% positive biopsy cores)
- Limited high risk: cT3a with PSA < 40ng/mL or cT2a-c with a Gleason score > 7 and/or a PSA > 20ng/mL but < 40ng/mL
- World Health Organization performance score 0-2
- Written informed consent
Intermediate risk factors: T2b-T2c, Gleason 7, PSA 10-20 ng/mL
- Transurethral resection (TUR) < 3months before SBRT
- International Prostate Symptom Score (IPSS) > 19
- Prostate volume > 100cc on transrectal ultrasound (TRUS)
- Stage cT3b-T4
- N1 disease (clinically or pathologically)
- M1 disease (clinically or pathologically)
- PSA > 40ng/mL
- inflammatory bowel disease
- immunosuppressive medications
- prior pelvic RT
- contra-indications for MRI
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MR-guided prostate stereotactic body radiotherapy MR-guided RT Patients will receive MR-guided RT in 5 fractions over 7 days (daily excluding weekend, i.e. start on Wednesday or Thursday, until Tuesday or Wednesday respectively the week after).
- Primary Outcome Measures
Name Time Method Acute toxicity according to CTCAE v 5.0 from the first treatment fraction up to 3 months Clinician reported grade 2 or more acute gastrointestinal (GI) or genitourinary (GU) toxicity, assessed using CTCAE v 5.0
Acute toxicity according to RTOG criteria from the first treatment fraction up to 3 months Clinician reported grade 2 or more acute gastrointestinal (GI) or genitourinary (GU) toxicity, assessed using RTOG criteria
- Secondary Outcome Measures
Name Time Method Late toxicity according to CTCAE v 5.0 within 5 years after start of radiotherapy Clinician reported late toxicity, assessed using CTCAE v 5.0
Freedom from biochemical failure from start of radiotherapy until PSA relapse, assessed up to 5 years the Phoenix definition is used to define PSA failure (i.e. nadir + 2ng/mL)
Late toxicity according to RTOG criteria within 5 years after start of radiotherapy Clinician reported late toxicity, assessed using RTOG criteria
Quality of life assessment from the start of radiotherapy until 5 years after treatment Quality of life according to EORTC Quality of life Questionnaire C30
IPSS quality of life from the start of radiotherapy until 5 years after treatment Quality of life according to International Prostate Symptom Score (IPSS)
Overall survival from start of radiotherapy until 5 years after treatment from start of radiotherapy until death from any cause
Prostate specific quality of life assessment from the start of radiotherapy until 5 years after treatment Quality of life according to EORTC Quality of life Questionnaire PR25
EPIC-26 quality of life from the start of radiotherapy until 5 years after treatment Quality of life according to Expanded Prostate Index Composite-26 (EPIC-26)
Disease-free survival from start of radiotherapy until 5 years after treatment from start of radiotherapy until first evidence of recurrence (loco-regional or distant) or death from any cause
Trial Locations
- Locations (1)
Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
🇧🇪Brussels, Belgium