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

• Sponsor: Centre Georges Francois Leclerc (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04909294
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 0.6

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Adenocarcinoma of the Prostate	Radiation: Stereotactic Radiotherapy with Linac MRI	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 68 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Oct 1, 2020
• Anticipated Primary Completion Date: Oct 1, 2025
• Anticipated Study Completion Date: Oct 1, 2030

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Late gastrointestinal and urinary toxicity grade ≥ 2 [5 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

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

2. Absence of pelvic or lumbar aortic lymphadenopathy

3. Absence of bone or visceral metastasis

4. IPSS score <15 or ≤ 7

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

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

7. Absence of prior pelvic radiotherapy

8. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Georges François Leclerc	Dijon		France	21000

Sponsors and Collaborators

• Centre Georges Francois Leclerc

Investigators

• Principal Investigator: Magali QUIVRIN, Centre Georges François Leclerc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Georges Francois Leclerc
• ClinicalTrials.gov Identifier: NCT04909294
• Other Study ID Numbers: STEREO-RML
• First Posted: Jun 1, 2021
• Last Update Posted: Jun 1, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Georges Francois Leclerc: radiotherapy
• Additional relevant MeSH terms: Adenocarcinoma

Study Results

No Results Posted as of Jun 1, 2021