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

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

MR-guided RT

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring MR-guided radiotherapy, Stereotactic body radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Department of Radiotherapy, UZ Brussel, Vrije Universiteit BrusselRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MR-guided prostate stereotactic body radiotherapy

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Acute toxicity according to RTOG criteria

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

Secondary Outcome Measures

Late toxicity according to CTCAE v 5.0

Clinician reported late toxicity, assessed using CTCAE v 5.0

Late toxicity according to RTOG criteria

Clinician reported late toxicity, assessed using RTOG criteria

Quality of life assessment

Quality of life according to EORTC Quality of life Questionnaire C30

Prostate specific quality of life assessment

Quality of life according to EORTC Quality of life Questionnaire PR25

EPIC-26 quality of life

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

IPSS quality of life

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

Freedom from biochemical failure

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

Disease-free survival

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

Overall survival

from start of radiotherapy until death from any cause

Full Information

NCT ID

NCT04896801

First Posted

May 13, 2021

Last Updated

June 12, 2023

Sponsor

Universitair Ziekenhuis Brussel

1. Study Identification

Unique Protocol Identification Number

NCT04896801

Brief Title

MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days

Acronym

Proseven

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 10, 2021 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

July 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

MR-guided radiotherapy, Stereotactic body radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MR-guided prostate stereotactic body radiotherapy

Arm Type

Experimental

Arm Description

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).

Intervention Type

Radiation

Intervention Name(s)

MR-guided RT

Intervention Description

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 Outcome Measure Information:

Title

Acute toxicity according to CTCAE v 5.0

Description

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

Time Frame

from the first treatment fraction up to 3 months

Title

Acute toxicity according to RTOG criteria

Description

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

Time Frame

from the first treatment fraction up to 3 months

Secondary Outcome Measure Information:

Title

Late toxicity according to CTCAE v 5.0

Description

Clinician reported late toxicity, assessed using CTCAE v 5.0

Time Frame

within 5 years after start of radiotherapy

Title

Late toxicity according to RTOG criteria

Description

Clinician reported late toxicity, assessed using RTOG criteria

Time Frame

within 5 years after start of radiotherapy

Title

Quality of life assessment

Description

Quality of life according to EORTC Quality of life Questionnaire C30

Time Frame

from the start of radiotherapy until 5 years after treatment

Title

Prostate specific quality of life assessment

Description

Quality of life according to EORTC Quality of life Questionnaire PR25

Time Frame

from the start of radiotherapy until 5 years after treatment

Title

EPIC-26 quality of life

Description

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

Time Frame

from the start of radiotherapy until 5 years after treatment

Title

IPSS quality of life

Description

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

Time Frame

from the start of radiotherapy until 5 years after treatment

Title

Freedom from biochemical failure

Description

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

Time Frame

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

Title

Disease-free survival

Description

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

Time Frame

from start of radiotherapy until 5 years after treatment

Title

Overall survival

Description

from start of radiotherapy until death from any cause

Time Frame

from start of radiotherapy until 5 years after treatment

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mark De Ridder, MD

Phone

00324776041

mark.deridder@uzbrussel.be

First Name & Middle Initial & Last Name or Official Title & Degree

Jacques Bezuidenhout, MD

jacques.bezuidenhout@uzbrussel.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark De Ridder, MD

Organizational Affiliation

Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel

City

Brussels

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mark De Ridder, MD

Phone

00324776041

mark.deridder@uzbrussel.be

First Name & Middle Initial & Last Name & Degree

Ka Lun Law

ka.lun.law@vub.be

First Name & Middle Initial & Last Name & Degree

Mark De Ridder, MD

First Name & Middle Initial & Last Name & Degree

Guy Soete, MD

First Name & Middle Initial & Last Name & Degree

Jacques Bezuidenhout, MD

First Name & Middle Initial & Last Name & Degree

Benedikt Engels, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days

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