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

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.

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

Study Overview

• Status: Active, not recruiting
• Conditions: Adenocarcinoma of the Prostate
• Intervention / Treatment: Radiation: Stereotactic Radiotherapy with Linac MRI

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Centre Georges Francois Leclerc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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: stereotaxic external radiation therapy	Radiation: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late gastrointestinal and urinary toxicity grade ≥ 2	toxicities graded according to the NCI-CTCAE-V5.0	5 years

Collaborators and Investigators

• Sponsor: Centre Georges Francois Leclerc
• Investigators: Principal Investigator: Magali QUIVRIN, Centre Georges Francois Leclerc

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: radiotherapy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: STEREO-RML

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No