An interventional study of MR-guided RT in Prostate Cancer, sponsored by Universitair Ziekenhuis Brussel. Recruiting at 1 site in Belgium. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 132 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Universitair Ziekenhuis Brussel is the lead sponsor of 362 studies on the registry; 103 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Intermediate risk factors: T2b-T2c, Gleason 7, PSA 10-20 ng/mL
Exclusion Criteria:
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
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
Time frame: 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
Time frame: from the first treatment fraction up to 3 months
Late toxicity according to CTCAE v 5.0
Clinician reported late toxicity, assessed using CTCAE v 5.0
Time frame: within 5 years after start of radiotherapy
Late toxicity according to RTOG criteria
Clinician reported late toxicity, assessed using RTOG criteria
Time frame: within 5 years after start of radiotherapy
Quality of life assessment
Quality of life according to EORTC Quality of life Questionnaire C30
Time frame: 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
Time frame: 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)
Time frame: from the start of radiotherapy until 5 years after treatment
IPSS quality of life
Quality of life according to International Prostate Symptom Score (IPSS)
Time frame: 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)
Time frame: 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
Time frame: from start of radiotherapy until 5 years after treatment
Overall survival
from start of radiotherapy until death from any cause
Time frame: from start of radiotherapy until 5 years after treatment
Plan to share: No
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Universitair Ziekenhuis Brussel