MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days

NCT04896801 | Recruiting DMC

• 1 other identifier: PRO7
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

MR-guided radiotherapy; Stereotactic body radiotherapy

Outcome Measures

Primary Outcomes (2)

• Acute toxicity according to CTCAE v 5.0

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

  from the first treatment fraction up to 3 months

• Acute toxicity according to RTOG criteria

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

  from the first treatment fraction up to 3 months

Secondary Outcomes (9)

• Late toxicity according to CTCAE v 5.0

  within 5 years after start of radiotherapy

• Late toxicity according to RTOG criteria

  within 5 years after start of radiotherapy

• Quality of life assessment

  from the start of radiotherapy until 5 years after treatment

• Prostate specific quality of life assessment

  from the start of radiotherapy until 5 years after treatment

• EPIC-26 quality of life

  from the start of radiotherapy until 5 years after treatment

Study Arms (1)

MR-guided prostate stereotactic body radiotherapy

EXPERIMENTAL

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).

Radiation: MR-guided RT

Interventions

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

MR-guided prostate stereotactic body radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel

Brussels, Belgium

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Mark De Ridder, MD

  Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark De Ridder, MD

CONTACT

00324776041; mark.deridder@uzbrussel.be

Jacques Bezuidenhout, MD

CONTACT

jacques.bezuidenhout@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 21, 2021
• Study Start: August 10, 2021
• Primary Completion: February 1, 2025
• Study Completion (Estimated): February 1, 2030
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)