MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days

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.

Eligibility

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

Conditions2

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