Clinical trial · Interventional
MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
Prospective Study of MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MR-guided RT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MR-guided prostate stereotactic body radiotherapy
- description
- 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).
- interventionNames
- Radiation: MR-guided RT
Primary outcomes (2)
- measure
- Acute toxicity according to CTCAE v 5.0
- timeFrame
- from the first treatment fraction up to 3 months
- description
- Clinician reported grade 2 or more acute gastrointestinal (GI) or genitourinary (GU) toxicity, assessed using CTCAE v 5.0
- measure
- Acute toxicity according to RTOG criteria
- timeFrame
- from the first treatment fraction up to 3 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available