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

NCT04909294 | Active Not Recruiting

• 1 other identifier: STEREO-RML
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Keywords

radiotherapy

Outcome Measures

Primary Outcomes (1)

• Late gastrointestinal and urinary toxicity grade ≥ 2

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

  5 years

Study Arms (1)

stereotaxic external radiation therapy

EXPERIMENTAL

Radiation: Stereotactic Radiotherapy with Linac MRI

Interventions

Stereotactic Radiotherapy with Linac MRI 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.

stereotaxic external radiation therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Absence of prior pelvic radiotherapy
• No surgical treatment for prostate cancer

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

Centre Georges François Leclerc

Dijon, 21000, France

Location

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Magali QUIVRIN

  Centre Georges François Leclerc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 1, 2021
• Study Start: October 1, 2020
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2030
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

FR (1)