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Recruiting NCT04896801

MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days

No phase Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MR-guided RT.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Study of MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days

Overview

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.

Interventions

  • 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-m

Primary outcome measures

  • Acute toxicity according to CTCAE v 5.0 [Time frame: from the first treatment fraction up to 3 months]
  • Acute toxicity according to RTOG criteria [Time frame: from the first treatment fraction up to 3 months]
Secondary outcome measures (9)
  • Late toxicity according to CTCAE v 5.0 [Time frame: within 5 years after start of radiotherapy]
  • Late toxicity according to RTOG criteria [Time frame: within 5 years after start of radiotherapy]
  • Quality of life assessment [Time frame: from the start of radiotherapy until 5 years after treatment]
  • Prostate specific quality of life assessment [Time frame: from the start of radiotherapy until 5 years after treatment]
  • EPIC-26 quality of life [Time frame: from the start of radiotherapy until 5 years after treatment]
  • IPSS quality of life [Time frame: from the start of radiotherapy until 5 years after treatment]
  • Freedom from biochemical failure [Time frame: from start of radiotherapy until PSA relapse, assessed up to 5 years]
  • Disease-free survival [Time frame: from start of radiotherapy until 5 years after treatment]
  • Overall survival [Time frame: from start of radiotherapy until 5 years after treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel — Brussels

Identifiers

NCT: NCT04896801 · PRO7

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗