Prostate Cancer RecurrentHISTO-RADNCT01857037
Post-radiation Prostate Cancer Local Recurrences: Detection With Histoscanning™ and MRI
A study testing Histoscanning™ and multiparametric MRI in people with Prostate Cancer Recurrent, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Inclusion criteria: Patients with biochemical recurrence (Phoenix criteria: PSA nadir + 2 ng/ml) after radiation therapy for prostate cancer addressed for prostate biopsy OR Patients referred to our institution for biopsy-proven local recurrence after radiation therapy for prostate cancer but needing a re-assessment… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Recurrent
- What is being tested?
- Histoscanning™ and multiparametric MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Aug 2014
- 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 biochemical recurrence (Phoenix criteria: PSA nadir + 2 ng/ml) after radiation therapy for prostate cancer addressed for prostate biopsy OR Patients referred to our institution for biopsy-proven local recurrence after radiation therapy for prostate cancer but needing a re-assessment with biopsy (insufficient number of biopsy and/or imprecise location of positive biopsy and/or questionable diagnostic of recurrence)
- IRB-approved informed consent signed
Who cannot join
- Contraindication to MRI
- Contraindication to endorectal examination
- Contraindication to prostate biopsy
- History of allergy to gadolinium chelates
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection and Localization of Prostate Cancer Local Recurrences After Radiation Therapy Using Histoscanning™ and Multiparametric MRI
Inclusion criteria:
- Patients with biochemical recurrence (Phoenix criteria: PSA nadir + 2 ng/ml) after radiation therapy for prostate cancer addressed for prostate biopsy OR
- Patients referred to our institution for biopsy-proven local recurrence after radiation therapy for prostate cancer but needing a re-assessment with biopsy (insufficient number of biopsy and/or imprecise location of positive biopsy and/or questionable diagnostic of recurrence)
Read more
Study Design:
- Included patients will undergo an endorectal US examination with a Histoscanning™ acquisition and a multiparametric (T2-weighted, diffusion-weighted and dynamic contrast-enhanced) MRI.
- Two independent operators will separately define suspicious focal lesion on Histoscanning™ images and on MR images.
- Random biopsies (at least 2 cores) will be performed in sextants negative at Histoscanning™ and at MRI ; In sextants positive at Histoscanning™ and/or at MRI, targeted biopsies will be performed in the suspicious part of the sextant (at least two cores per suspicious lesion).
- Histoscanning™ and MRI results will be compared to biopsy results.
A total of 30 patients will be included
- Conditions
- Prostate Cancer Recurrent
- Being tested
- Histoscanning™ and multiparametric MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histoscanning™ and multiparametric MRIOther
Detection and localization of prostate cancer local recurrences after radiation therapy using Histoscanning™ and multiparametric MRI
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Single arm Receives: Other: Histoscanning™ and multiparametric MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Histoscanning™ after radiation therapy in comparison to random and targeted biopsy.
Histoscanning and biopsy findings will be compared on a sextant by sextant basis. A mixed effects logistic regression model (with fixed and random effects) will be used to model the sensitivity and specificity of Histoscanning to correctly identify the presence or absence of cancer into prostate sextants.
Measured: 1 day
Secondary outcomes (1)
Evaluation of multiparametric MRI after radiation therapy in comparison to random and targeted biopsy.
MRI and biopsy findings will be compared on a sextant by sextant basis. A mixed effects logistic regression model (with fixed and random effects) will be used to model the sensitivity and specificity of MRI to correctly identify the presence or absence of cancer into prostate sextants.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startMay 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer RecurrentStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Rouvière, Pr, Principal investigator, Hospices Civiles de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857037
- Sponsor's protocol ID
- 2010.655
- Acronym
- HISTO-RAD
- Status last verified
- Sep 2025
- First submitted
- 28 Mar 2012
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Alonzo F, Melodelima C, Bratan F, Vitry T, Crouzet S, Gelet A, Rouviere O. Detection of locally radio-recurrent prostate cancer at multiparametric MRI: Can dynamic contrast-enhanced imaging be omitted? Diagn Interv Imaging. 2016 Apr;97(4):433-41. doi: 10.1016/j.diii.2016.01.008. Epub 2016 Feb 23.
PubMed 26928245
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Localization of Prostate Cancer Local Recurrences After Radiation Therapy Using Histoscanning™ and Multiparametric MRI
- ClinicalTrials.gov ID
- NCT01857037
- Acronym / sponsor ID
- HISTO-RAD / 2010.655
- Conditions
- Prostate Cancer Recurrent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 May 2013 (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.
Inclusion criteria:
- Patients with biochemical recurrence (Phoenix criteria: PSA nadir + 2 ng/ml) after radiation therapy for prostate cancer addressed for prostate biopsy OR
- Patients referred to our institution for biopsy-proven local recurrence after radiation therapy for prostate cancer but needing a re-assessment with biopsy (insufficient number of biopsy and/or imprecise location of positive biopsy and/or questionable diagnostic of recurrence)
Study Design:
- Included patients will undergo an endorectal US examination with a Histoscanning™ acquisition and a multiparametric (T2-weighted, diffusion-weighted and dynamic contrast-enhanced) MRI.
- Two independent operators will separately define suspicious focal lesion on Histoscanning™ images and on MR images.
- Random biopsies (at least 2 cores) will be performed in sextants negative at Histoscanning™ and at MRI ; In sextants positive at Histoscanning™ and/or at MRI, targeted biopsies will be performed in the suspicious part of the sextant (at least two cores per suspicious lesion).
- Histoscanning™ and MRI results will be compared to biopsy results.
A total of 30 patients will be included
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Other: Histoscanning™ and multiparametric MRISingle arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with biochemical recurrence (Phoenix criteria: PSA nadir + 2 ng/ml) after radiation therapy for prostate cancer addressed for prostate biopsy OR Patients referred to our institution for biopsy-proven local recurrence after radiation therapy for prostate cancer but needing a re-assessment with biopsy (insufficient number of biopsy and/or imprecise location of positive biopsy and/or questionable diagnostic of recurrence)
- IRB-approved informed consent signed
Key exclusion criteria (4 listed)
- Contraindication to MRI
- Contraindication to endorectal examination
- Contraindication to prostate biopsy
- History of allergy to gadolinium chelates
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 |
|---|---|---|
| Histoscanning™ and multiparametric MRIDetection and localization of prostate cancer local recurrences after radiation therapy using Histoscanning™ and multiparametric MRI | Other | Single arm |
Primary outcome
Evaluation of Histoscanning™ after radiation therapy in comparison to random and targeted biopsy.
Time frame: 1 day
Histoscanning and biopsy findings will be compared on a sextant by sextant basis. A mixed effects logistic regression model (with fixed and random effects) will be used to model the sensitivity and specificity of Histoscanning to correctly identify the presence or absence of cancer into prostate sextants.
1 secondary outcome
Evaluation of multiparametric MRI after radiation therapy in comparison to random and targeted biopsy.
Time frame: 1 day
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 3 Sep 2025.
- Results publication: PubMed 26928245Alonzo F, Melodelima C, Bratan F, Vitry T, Crouzet S, Gelet A, Rouviere O. Detection of locally radio-recurrent prostate cancer at multiparametric MRI: Can dynamic contrast-enhanced imaging be omitted? Diagn Interv Imaging. 2016 Apr;97(4):433-41. doi: 10.1016/j.diii.2016.01.008. Epub 2016 Feb 23.
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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.
Olivier Rouvière, Pr principal investigator
Hospices Civiles de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Histoscanning™ and multiparametric MRI in people with Prostate Cancer Recurrent, run by Hospices Civils de Lyon 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 2 inclusion and 4 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 3 Sep 2025. 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?
Evaluation of Histoscanning™ after radiation therapy in comparison to random and targeted biopsy. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01857037, which also lists 1 linked publication.
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 3 Sep 2025.