Adenocarcinoma of the ProstateSTEREO-RMLNCT04909294
Evaluation of the Efficacy and the Safety of a Stereotaxic Prostatic Radiotherapy Delivered With Linac MRI, in Patients With Prostate Adenocarcinoma
A study testing Stereotactic Radiotherapy with Linac MRI in people with Adenocarcinoma of the Prostate, run by Centre Georges Francois Leclerc at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate
- What is being tested?
- Stereotactic Radiotherapy with Linac MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2020to 1 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- Stereotactic Radiotherapy with Linac MRI
- Keywords
- radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Radiotherapy with Linac MRIRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| stereotaxic external radiation therapy | Experimental | Not described Receives: Radiation: Stereotactic Radiotherapy with Linac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late gastrointestinal and urinary toxicity grade ≥ 2
toxicities graded according to the NCI-CTCAE-V5.0
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 Oct 2020
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magali QUIVRIN, Principal investigator, Centre Georges François Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909294
- Sponsor's protocol ID
- STEREO-RML
- Acronym
- STEREO-RML
- Status last verified
- Feb 2024
- First submitted
- 21 May 2021
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04909294
- Acronym / sponsor ID
- STEREO-RML / STEREO-RML
- Conditions
- Adenocarcinoma of the Prostate
- Keywords
- radiotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stereotaxic external radiation therapy | Experimental | Radiation: Stereotactic Radiotherapy with Linac MRI |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- prostate adenocarcinoma
- WHO performance index ≤ 1
- Patient presenting one of the following cases:
- Disease presenting a risk of lymph node involvement <15%
- Absence of pelvic or lumbar aortic lymphadenopathy
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Radiotherapy with Linac MRI38 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. | Radiation | stereotaxic external radiation therapy |
Primary outcome
Late gastrointestinal and urinary toxicity grade ≥ 2
Time frame: 5 years
toxicities graded according to the NCI-CTCAE-V5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
Related trials for Adenocarcinoma of the Prostate
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 1
Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)
Prostate Cancer, Prostate Adenocarcinoma
Not yet recruitingPhase 2
Testing the Anti-cancer Drug DSP-5336 (Enzomenib) in Prostate Cancer
Metastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magali QUIVRIN principal investigator
Centre Georges François Leclerc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Radiotherapy with Linac MRI in people with Adenocarcinoma of the Prostate, run by Centre Georges Francois Leclerc at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late gastrointestinal and urinary toxicity grade ≥ 2 (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.