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

NCT ID: NCT04909294

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2030-10-01

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

Conditions

Adenocarcinoma of the Prostate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

stereotaxic external radiation therapy

Group Type: EXPERIMENTAL

Stereotactic Radiotherapy with Linac MRI

Intervention Type: RADIATION

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.

Interventions

Stereotactic Radiotherapy with Linac MRI

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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. prostate adenocarcinoma

2. WHO performance index ≤ 1

3. 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

4. Disease presenting a risk of lymph node involvement <15%

5. Absence of pelvic or lumbar aortic lymphadenopathy

6. Absence of bone or visceral metastasis

7. IPSS score <15 or ≤ 7

8. Prostate volume estimated by MRI or ultrasound < 90cc

9. If hormonotherapy, hormone therapy must not have started for more than 60 days before inclusion.

10. Absence of prior pelvic radiotherapy

11. No surgical treatment for prostate cancer

Exclusion Criteria

1. Prostate cancer of histology other than adenocarcinoma

2. Contraindication to MRI including, but not limited to, patients with a pacemaker or defibrillator

3. Patient diagnosed N1 during imaging workup or pN1

4. Serum PSA level ≥ 15 ng / ml

5. IPSS score ≥ 15 or IPSS score> 7 if alpha blocking urological treatment in progress

6. Prostate volume estimated on MRI or ultrasound> 90 cc

7. Involvement of seminal vesicles on MRI

8. History of cancer in the 5 years preceding entry into the trial

9. History of transurethral resection of the prostate less than 6 months compared to the expected date of start of radiotherapy

10. rectal surgery

11. pelvic irradiation

12. Patient treated with antineoplastic or medication which may include Methotrexate

13. Hormone therapy started for more than 60 days at the time of inclusion

14. Severe uncontrolled hypertension

15. Patient followed or treated for severe or unstable angina, or having presented a myocardial infarction in the 6 months preceding the randomization

16. Patient on immunosuppressant

17. Patient with known hypersensitivity to gadoteric acid, meglumine or any drug containing gadolinium

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Georges Francois Leclerc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Magali QUIVRIN

Role: PRINCIPAL_INVESTIGATOR

Centre Georges François Leclerc

Locations

Centre Georges François Leclerc

Dijon, , France

Countries

France

Other Identifiers

STEREO-RML

Identifier Type: -

Identifier Source: org_study_id