Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT04896801

MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days

Led by Universitair Ziekenhuis Brussel · Updated on 2024-12-04

132

Participants Needed

1

Research Sites

442 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 18 years
  • Histologically confirmed prostate adenocarcinoma
  • Low risk: clinical stage T1c-T2a, Gleason score 6, PSA < 10 ng/mL
  • Favorable intermediate risk: 1 intermediate risk factor, Gleason 3+4 or less, less than 50% positive biopsy cores
  • Unfavorable intermediate risk: more than 1 intermediate risk factor, Gleason 4+3, more than 50% positive biopsy cores
  • Limited high risk: clinical stage T3a with PSA < 40 ng/mL or clinical stage T2a-c with Gleason score > 7 and/or PSA > 20 ng/mL but < 40 ng/mL
  • World Health Organization performance score 0-2
  • Written informed consent
Not Eligible

You will not qualify if you...

  • Transurethral resection (TUR) less than 3 months before stereotactic body radiotherapy
  • International Prostate Symptom Score (IPSS) greater than 19
  • Prostate volume greater than 100 cc on transrectal ultrasound
  • Clinical stage T3b-T4
  • N1 disease (clinically or pathologically)
  • M1 disease (clinically or pathologically)
  • PSA greater than 40 ng/mL
  • Inflammatory bowel disease
  • Use of immunosuppressive medications
  • Prior pelvic radiotherapy
  • Contraindications for MRI

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel

Brussels, Belgium

Actively Recruiting

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Research Team

M

Mark De Ridder, MD

CONTACT

J

Jacques Bezuidenhout, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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