Proseven: MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MR-guided prostate stereotactic body radiotherapy 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
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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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)
- IPSS quality of life [from the start of radiotherapy until 5 years after treatment]
Quality of life according to International Prostate Symptom Score (IPSS)
- 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)
- 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
- Overall survival [from start of radiotherapy until 5 years after treatment]
from start of radiotherapy until death from any cause
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > 18 y
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Histologically confirmed prostate adenocarcinoma
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Low risk: cT1c-T2a, Gleason score 6, PSA < 10ng/mL
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Favorable intermediate risk: 1 intermediate risk factor, Gleason 3+4 or less, < 50% positive biopsy cores)
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Unfavorable intermediate risk: > 1 intermediate risk factor, Gleason 4+3, > 50% positive biopsy cores)
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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
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World Health Organization performance score 0-2
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Written informed consent
Intermediate risk factors: T2b-T2c, Gleason 7, PSA 10-20 ng/mL
Exclusion Criteria:
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Transurethral resection (TUR) < 3months before SBRT
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International Prostate Symptom Score (IPSS) > 19
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Prostate volume > 100cc on transrectal ultrasound (TRUS)
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Stage cT3b-T4
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N1 disease (clinically or pathologically)
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M1 disease (clinically or pathologically)
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PSA > 40ng/mL
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inflammatory bowel disease
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immunosuppressive medications
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prior pelvic RT
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contra-indications for MRI
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel | Brussels | Belgium |
Sponsors and Collaborators
- Universitair Ziekenhuis Brussel
Investigators
- Principal Investigator: Mark De Ridder, MD, Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO7