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NCT Number: NCT04896801

MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel

Brussels, Belgium

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MR-guided RT

Radiation

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-modulated RT

Primary outcomes

  1. Acute toxicity according to CTCAE v 5.0

    Time frame: from the first treatment fraction up to 3 months

    Clinician reported grade 2 or more acute gastrointestinal (GI) or genitourinary (GU) toxicity, assessed using CTCAE v 5.0

  2. Acute toxicity according to RTOG criteria

    Time frame: from the first treatment fraction up to 3 months

    Clinician reported grade 2 or more acute gastrointestinal (GI) or genitourinary (GU) toxicity, assessed using RTOG criteria

Secondary outcomes

  1. Late toxicity according to CTCAE v 5.0

    Time frame: within 5 years after start of radiotherapy

    Clinician reported late toxicity, assessed using CTCAE v 5.0

  2. Late toxicity according to RTOG criteria

    Time frame: within 5 years after start of radiotherapy

    Clinician reported late toxicity, assessed using RTOG criteria

  3. Quality of life assessment

    Time frame: from the start of radiotherapy until 5 years after treatment

    Quality of life according to EORTC Quality of life Questionnaire C30

  4. Prostate specific quality of life assessment

    Time frame: from the start of radiotherapy until 5 years after treatment

    Quality of life according to EORTC Quality of life Questionnaire PR25

  5. EPIC-26 quality of life

    Time frame: from the start of radiotherapy until 5 years after treatment

    Quality of life according to Expanded Prostate Index Composite-26 (EPIC-26)

  6. IPSS quality of life

    Time frame: from the start of radiotherapy until 5 years after treatment

    Quality of life according to International Prostate Symptom Score (IPSS)

  7. Freedom from biochemical failure

    Time frame: from start of radiotherapy until PSA relapse, assessed up to 5 years

    the Phoenix definition is used to define PSA failure (i.e. nadir + 2ng/mL)

  8. Disease-free survival

    Time frame: from start of radiotherapy until 5 years after treatment

    from start of radiotherapy until first evidence of recurrence (loco-regional or distant) or death from any cause

  9. Overall survival

    Time frame: from start of radiotherapy until 5 years after treatment

    from start of radiotherapy until death from any cause

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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

Acronym: Proseven

Important dates

Study start
2021
Primary completion
2025
Study completion
2030
First posted
May 21, 2021
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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