MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days (Proseven)

Universitair Ziekenhuis Brussel

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Radiation: MR-guided RT

Study type: Interventional

Funder types: Other

Identifiers

NCT04896801

PRO7

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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132 participants in 1 patient group

MR-guided prostate stereotactic body radiotherapy

Experimental group

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).

Treatment:

Radiation: MR-guided RT