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Evaluation of the Efficacy and the Safety of a Stereotaxic Prostatic Radiotherapy Delivered With Linac MRI, in Patients With Prostate Adenocarcinoma (STEREO-RML)

Primary Purpose

Adenocarcinoma of the Prostate

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Stereotactic Radiotherapy with Linac MRI

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Prostate focused on measuring radiotherapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

prostate adenocarcinoma
WHO performance index ≤ 1
Patient presenting one of the following cases:
- Low risk: ≤ T2a and Gleason 6 (3 + 3) and PSA <10 ng / ml
- Intermediate risk: T2b-T2c or Gleason 7 or PSA <15 ng / ml
- High localized risk: T3a and Gleason ≤7 and PSA <15 ng / ml
Disease presenting a risk of lymph node involvement <15%
Absence of pelvic or lumbar aortic lymphadenopathy
Absence of bone or visceral metastasis
IPSS score <15 or ≤ 7
Prostate volume estimated by MRI or ultrasound < 90cc
If hormonotherapy, hormone therapy must not have started for more than 60 days before inclusion.
Absence of prior pelvic radiotherapy
No surgical treatment for prostate cancer

Exclusion Criteria:

Prostate cancer of histology other than adenocarcinoma
Contraindication to MRI including, but not limited to, patients with a pacemaker or defibrillator
Patient diagnosed N1 during imaging workup or pN1
Serum PSA level ≥ 15 ng / ml
IPSS score ≥ 15 or IPSS score> 7 if alpha blocking urological treatment in progress
Prostate volume estimated on MRI or ultrasound> 90 cc
Involvement of seminal vesicles on MRI
History of cancer in the 5 years preceding entry into the trial
History of transurethral resection of the prostate less than 6 months compared to the expected date of start of radiotherapy
rectal surgery
pelvic irradiation
Patient treated with antineoplastic or medication which may include Methotrexate
Hormone therapy started for more than 60 days at the time of inclusion
Severe uncontrolled hypertension
Patient followed or treated for severe or unstable angina, or having presented a myocardial infarction in the 6 months preceding the randomization
Patient on immunosuppressant
Patient with known hypersensitivity to gadoteric acid, meglumine or any drug containing gadolinium

Sites / Locations

Centre Georges François LeclercRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

stereotaxic external radiation therapy

Arm Description

Outcomes

Primary Outcome Measures

Late gastrointestinal and urinary toxicity grade ≥ 2

toxicities graded according to the NCI-CTCAE-V5.0

Secondary Outcome Measures

Full Information

NCT ID

NCT04909294

First Posted

May 21, 2021

Last Updated

May 27, 2021

Sponsor

Centre Georges Francois Leclerc

1. Study Identification

Unique Protocol Identification Number

NCT04909294

Brief Title

Evaluation of the Efficacy and the Safety of a Stereotaxic Prostatic Radiotherapy Delivered With Linac MRI, in Patients With Prostate Adenocarcinoma

Acronym

STEREO-RML

Official Title

Multicenter Phase II Study Evaluating the Efficacy and Safety of a Stereotaxic Prostatic Radiotherapy Delivered on Linac MRI, With Integrated Boost in the Case of an Index Tumor, in Patients With Prostate Adenocarcinoma of Favorable, Intermediate or Risky Risk. High Risk Very Localized.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2020 (Actual)

Primary Completion Date

October 1, 2025 (Anticipated)

Study Completion Date

October 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Georges Francois Leclerc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Stereotaxic prostatic radiotherapy on Linac MRI, with monitoring of movements of the pelvic organs per fraction on the prostate in real time, in 4 sessions, with integrated boost on the index tumor (if it is visible on the diagnostic MRI), could reduce the digestive, urinary and sexual toxicities accumulated at 5 years and guarantee excellent local tumor control, for patients with localized prostate cancer, with a favorable prognosis, intermediate or very local high risk, according to the D'Amico classification. The benefits that patients participating in this research could obtain are: Better disease control efficiency A reduction in the duration of treatment to 4 radiotherapy sessions (2 weeks maximum) instead of 40 sessions (8 weeks) for usual treatment. Avoid the risks associated with the implantation of prostate markers necessary for stereotaxic radiotherapy on a standard accelerator (anesthetic risks, infectious risks, hemorrhagic risks, pain risks) Better quality of life

6. Conditions and Keywords

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

Adenocarcinoma of the Prostate

Keywords

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

68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

stereotaxic external radiation therapy

Arm Type

Experimental

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Radiotherapy with Linac MRI

Intervention Description

38 Gy in 4 fractions of 9.5 Gy over the entire prostate, +/- 2 Gy in 4 fractions of 0.5 Gy as an integrated boost on the index tumor if it is visible on diagnostic multiparametric MRI (PIRADS-V2 score 4 or 5) and on planning MRI performed on Linac MRI.

Primary Outcome Measure Information:

Title

Late gastrointestinal and urinary toxicity grade ≥ 2

Description

toxicities graded according to the NCI-CTCAE-V5.0

Time Frame

5 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: prostate adenocarcinoma WHO performance index ≤ 1 Patient presenting one of the following cases: Low risk: ≤ T2a and Gleason 6 (3 + 3) and PSA <10 ng / ml Intermediate risk: T2b-T2c or Gleason 7 or PSA <15 ng / ml High localized risk: T3a and Gleason ≤7 and PSA <15 ng / ml Disease presenting a risk of lymph node involvement <15% Absence of pelvic or lumbar aortic lymphadenopathy Absence of bone or visceral metastasis IPSS score <15 or ≤ 7 Prostate volume estimated by MRI or ultrasound < 90cc If hormonotherapy, hormone therapy must not have started for more than 60 days before inclusion. Absence of prior pelvic radiotherapy No surgical treatment for prostate cancer Exclusion Criteria: Prostate cancer of histology other than adenocarcinoma Contraindication to MRI including, but not limited to, patients with a pacemaker or defibrillator Patient diagnosed N1 during imaging workup or pN1 Serum PSA level ≥ 15 ng / ml IPSS score ≥ 15 or IPSS score> 7 if alpha blocking urological treatment in progress Prostate volume estimated on MRI or ultrasound> 90 cc Involvement of seminal vesicles on MRI History of cancer in the 5 years preceding entry into the trial History of transurethral resection of the prostate less than 6 months compared to the expected date of start of radiotherapy rectal surgery pelvic irradiation Patient treated with antineoplastic or medication which may include Methotrexate Hormone therapy started for more than 60 days at the time of inclusion Severe uncontrolled hypertension Patient followed or treated for severe or unstable angina, or having presented a myocardial infarction in the 6 months preceding the randomization Patient on immunosuppressant Patient with known hypersensitivity to gadoteric acid, meglumine or any drug containing gadolinium

Central Contact Person:

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

Emilie REDERSTORFF

Phone

03 45 34 81 16

erederstorff@cgfl.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Magali QUIVRIN

Organizational Affiliation

Centre Georges François Leclerc

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Georges François Leclerc

City

Dijon

ZIP/Postal Code

21000

Country

France

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Efficacy and the Safety of a Stereotaxic Prostatic Radiotherapy Delivered With Linac MRI, in Patients With Prostate Adenocarcinoma

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