MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Study of MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: MR-guided RT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MR-guided prostate stereotactic body radiotherapy<br>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). | Radiation: MR-guided RT<br>* The dose to the planning target volume (PTV) is 36 Gy (5 x 7.2 Gy) prescribed on the 90% isodose line. The clinical target volume (CTV) is receiving 40 Gy (5 x 8 Gy = 100%). A simultaneous integrated boost (SIB) up to a total dose of 42 Gy (5 x 8.4 Gy = 105%) is delivered to the gross tumor volume (GTV), if present. In addition, relative sparing of the urethra will be applied by avoiding hotspots (V40 Gy < 1cc) in the urethra. Baseline and adapted treatment plans are generated using intensity-modulated RT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity according to CTCAE v 5.0 | Clinician reported grade 2 or more acute gastrointestinal (GI) or genitourinary (GU) toxicity, assessed using CTCAE v 5.0 | from the first treatment fraction up to 3 months | 
| Acute toxicity according to RTOG criteria | Clinician reported grade 2 or more acute gastrointestinal (GI) or genitourinary (GU) toxicity, assessed using RTOG criteria | from the first treatment fraction up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late toxicity according to CTCAE v 5.0 | Clinician reported late toxicity, assessed using CTCAE v 5.0 | within 5 years after start of radiotherapy | 
| Late toxicity according to RTOG criteria | Clinician reported late toxicity, assessed using RTOG criteria | within 5 years after start of radiotherapy | 
| Quality of life assessment | Quality of life according to EORTC Quality of life Questionnaire C30 | from the start of radiotherapy until 5 years after treatment | 
| Prostate specific quality of life assessment | Quality of life according to EORTC Quality of life Questionnaire PR25 | from the start of radiotherapy until 5 years after treatment | 
| EPIC-26 quality of life | Quality of life according to Expanded Prostate Index Composite-26 (EPIC-26) | from the start of radiotherapy until 5 years after treatment | 
| IPSS quality of life | Quality of life according to International Prostate Symptom Score (IPSS) | from the start of radiotherapy until 5 years after treatment | 
| Freedom from biochemical failure | the Phoenix definition is used to define PSA failure (i.e. nadir + 2ng/mL) | from start of radiotherapy until PSA relapse, assessed up to 5 years | 
| Disease-free survival | from start of radiotherapy until first evidence of recurrence (loco-regional or distant) or death from any cause | from start of radiotherapy until 5 years after treatment | 
| Overall survival | from start of radiotherapy until death from any cause | from start of radiotherapy until 5 years after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MR-guided radiotherapy, Stereotactic body radiotherapy