Prostate CancerERISNCT01412853
Spectro-IRM and Evaluation Response to Prostatic Radiotherapy
A study testing MR-Spectroscopy in people with Prostate Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
Trial summary
Context: Prostate cancer is the most common non-cutaneous cancer and the second most common cause of cancer-related deaths in European and North-American men. After external radiotherapy or brachytherapy, the Prostate Specific Antigen (PSA) value is often fluctuating and PSA nadir may only be reached after 2 years or… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MR-Spectroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2008to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a biopsy-proven prostatic adenocarcinoma
- Gleason score between 4 and 10
- Maximal baseline PSA < 50 ng/ml
- Age over or = to 18 yr
- Exclusive radiotherapy and/or brachytherapy with or without androgen deprivation therapy
- Written informed consent from the patient
Who cannot join
- lymph-node metastases
- Bone metastases
- Maximal baseline PSA ≥ 50 ng/ml
- Prior radical prostatectomy
- Contra-indications for MRI (Pace-maker, hip prothesis…)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Response to Irradiation With MR-Spectroscopy for Localised Prostate Cancer Patients (The ERIS Trial)
Context:
Prostate cancer is the most common non-cutaneous cancer and the second most common cause of cancer-related deaths in European and North-American men.
Read more
After external radiotherapy or brachytherapy, the Prostate Specific Antigen (PSA) value is often fluctuating and PSA nadir may only be reached after 2 years or more and may remain detectable several years after the completion of radiation. Moreover, PSA bounces and blips render patients and physicians very anxious about any possibility of a relapse. In this context, biomarkers that could predict the response to radiation earlier than PSA for patients with prostate cancer appear long overdue.
Magnetic Resonance Spectroscopy at 3 Tesla without endorectal coil is a non invasive procedure which allows quantification of metabolites such as Choline, Creatine, Polyamines and Citrate within the prostate gland.
Objectives:
The investigators are conducting a French prospective study on the Evaluation of the Response to Irradiation with MR Spectroscopy (ERIS). Their purpose is to monitor the early response of radiation with 3D MR Spectroscopy during the first year after completion of radiation and its impact on biochemical control. Therefore, the ERIS trial aims to investigate whether or not there could be a correlation between the time course of PSA and that of Choline and Citrate.
- Conditions
- Prostate Cancer
- Being tested
- MR-Spectroscopy
- Keywords
- localized
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-SpectroscopyOther
response to standard radiotherapy treatment will be estimated for each patient every 3 months up to one year from the end of the radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| MR-spectroscopy | Experimental | Not described Receives: Other: MR-Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA value compare to Choline and Citrate levels as measured with MR-spectroscopic imaging as predictive factor of the response to treatment
Data will be collected at the end of the radiotherapy and every 3 months up to 1 year for each patient. Data analysis will be performed at the end of data completion in december 2011.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startFeb 2008
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412853
- Sponsor's protocol ID
- 0203-1crgi 07/005-046
- Acronym
- ERIS
- Status last verified
- Jun 2016
- First submitted
- 8 Aug 2011
- Last updated
- 21 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Response to Irradiation With MR-Spectroscopy for Localised Prostate Cancer Patients (The ERIS Trial)
- ClinicalTrials.gov ID
- NCT01412853
- Acronym / sponsor ID
- ERIS / 0203-1crgi 07/005-046
- Conditions
- Prostate Cancer
- Keywords
- localized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- Feb 2008 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Aug 2011 (estimated)
- 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.
Context:
Prostate cancer is the most common non-cutaneous cancer and the second most common cause of cancer-related deaths in European and North-American men.
After external radiotherapy or brachytherapy, the Prostate Specific Antigen (PSA) value is often fluctuating and PSA nadir may only be reached after 2 years or more and may remain detectable several years after the completion of radiation. Moreover, PSA bounces and blips render patients and physicians very anxious about any possibility of a relapse. In this context, biomarkers that could predict the response to radiation earlier than PSA for patients with prostate cancer appear long overdue.
Magnetic Resonance Spectroscopy at 3 Tesla without endorectal coil is a non invasive procedure which allows quantification of metabolites such as Choline, Creatine, Polyamines and Citrate within the prostate gland.
Objectives:
The investigators are conducting a French prospective study on the Evaluation of the Response to Irradiation with MR Spectroscopy (ERIS). Their purpose is to monitor the early response of radiation with 3D MR Spectroscopy during the first year after completion of radiation and its impact on biochemical control. Therefore, the ERIS trial aims to investigate whether or not there could be a correlation between the time course of PSA and that of Choline and Citrate.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR-spectroscopy | Experimental | Other: MR-Spectroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a biopsy-proven prostatic adenocarcinoma
- Gleason score between 4 and 10
- Maximal baseline PSA < 50 ng/ml
- Age over or = to 18 yr
- Exclusive radiotherapy and/or brachytherapy with or without androgen deprivation therapy
Key exclusion criteria (5 listed)
- lymph-node metastases
- Bone metastases
- Maximal baseline PSA ≥ 50 ng/ml
- Prior radical prostatectomy
- Contra-indications for MRI (Pace-maker, hip prothesis…)
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 |
|---|---|---|
| MR-Spectroscopyresponse to standard radiotherapy treatment will be estimated for each patient every 3 months up to one year from the end of the radiotherapy | Other | MR-spectroscopy |
Primary outcome
PSA value compare to Choline and Citrate levels as measured with MR-spectroscopic imaging as predictive factor of the response to treatment
Time frame: up to 1 year
Data will be collected at the end of the radiotherapy and every 3 months up to 1 year for each patient. Data analysis will be performed at the end of data completion in december 2011.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR-Spectroscopy in people with Prostate Cancer, 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 21 Jun 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PSA value compare to Choline and Citrate levels as measured with MR-spectroscopic imaging as predictive factor of the response to treatment (time frame: up to 1 year). 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 21 Jun 2017.