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

Prospective Study of 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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: MR-guided RT

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark De Ridder, MD; Phone Number: 00324776041; Email: mark.deridder@uzbrussel.be
• Study Contact Backup: Name: Jacques Bezuidenhout, MD; Email: jacques.bezuidenhout@uzbrussel.be

Study Locations

• Belgium
  • Brussels, Belgium
    • Recruiting
    • Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
    • Contact: Mark De Ridder, MD; Phone Number: 00324776041; Email: mark.deridder@uzbrussel.be
    • Contact: Ka Lun Law; Email: ka.lun.law@vub.be
    • Principal Investigator: Mark De Ridder, MD
    • Sub-Investigator: Guy Soete, MD
    • Sub-Investigator: Jacques Bezuidenhout, MD
    • Sub-Investigator: Benedikt Engels, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MR-guided prostate stereotactic body radiotherapy; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late toxicity according to CTCAE v 5.0	Clinician reported late toxicity, assessed using CTCAE v 5.0	within 5 years after start of radiotherapy
Late toxicity according to RTOG criteria	Clinician reported late toxicity, assessed using RTOG criteria	within 5 years after start of radiotherapy
Quality of life assessment	Quality of life according to EORTC Quality of life Questionnaire C30	from the start of radiotherapy until 5 years after treatment
Prostate specific quality of life assessment	Quality of life according to EORTC Quality of life Questionnaire PR25	from the start of radiotherapy until 5 years after treatment
EPIC-26 quality of life	Quality of life according to Expanded Prostate Index Composite-26 (EPIC-26)	from the start of radiotherapy until 5 years after treatment
IPSS quality of life	Quality of life according to International Prostate Symptom Score (IPSS)	from the start of radiotherapy until 5 years after treatment
Freedom from biochemical failure	the Phoenix definition is used to define PSA failure (i.e. nadir + 2ng/mL)	from start of radiotherapy until PSA relapse, assessed up to 5 years
Disease-free survival	from start of radiotherapy until first evidence of recurrence (loco-regional or distant) or death from any cause	from start of radiotherapy until 5 years after treatment
Overall survival	from start of radiotherapy until death from any cause	from start of radiotherapy until 5 years after treatment

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Mark De Ridder, MD, Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: May 13, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Stereotactic body radiotherapy; MR-guided radiotherapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PRO7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes