Prostatic NeoplasmsNCT03533998
Biomarkers in Prostate Cancer Treated With SRP Following Failure of FAT
An observational study of Prostatic Neoplasms, run by Institut Mutualiste Montsouris at 1 site in France.
Trial summary
The ability of genomic biomarkers to Measuring tumour aggressiveness, and facilitate the selection of therapies in patients who had salvage radical prostatectomy after focal therapy and predict the risk of biochemical recurrence BCR after focal therapy or RP. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Prostatic Neoplasms
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2018to 30 Sep 2018
- Phase
- Observational
- 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 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Between 2007 and 2017, 30 patients underwent salvage radical prostatectomy SRP for recurrent localized PCa at our institution (Institute Mutualiste Montsouris).
Who may be able to join
- Prostate Cancer treated with salvage radical prostatectomy following failure of focal ablative therapies
Who cannot join
- Primary radiotherapy, brachytherapy and whole-gland treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarkers in Prostate Cancer Treated With Salvage Radical Prostatectomy Following Failure of Focal Ablative Therapies
The ability of genomic biomarkers to Measuring tumour aggressiveness, and facilitate the selection of therapies in patients who had salvage radical prostatectomy after focal therapy and predict the risk of biochemical recurrence BCR after focal therapy or RP.
Read the detailed description
Between 2007 and 2017, 30 patients underwent salvage radical prostatectomy SRP for recurrent localized PCa at our institution (Institute Mutual Montsouris). Primary radiotherapy, brachytherapy and whole-gland treatments were excluded, as to evaluate the true spectrum of morphologic changes caused by the focal emerging ablative modalities. Thirteen SRP after focal ablative therapies FAT (cryotherapy or high intensity focused ultrasound- HIFU or vascular-targeted photodynamic therapy- VTP) were identified from our prospective collected database. Genitourinary pathologists were provided clinical information related to prior therapies and immunohistochemical (IHC) markers were used in the diagnosis of limited primary PC on needle biopsy when necessary. Prostatectomy specimens were processed and the number of tumor foci, size of the dominant focus and pathological stage were recorded. Residual disease was graded according to the Gleason grading system. Treatment-related histologic changes were examined.
- Conditions
- Prostatic Neoplasms
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
ability of genomic biomarkers to Measuring tumour aggressiveness
Fragment of Paraffin specimen after RP will be used for the analyses by Biomarkers; MYC, PTEN protein loss, chromosome 8 alterations
.
Measured: molecular analyses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start31 May 2018 (estimated)
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qusay Mandoorah, resident, Principal investigator, Institut Mutualiste Montsouris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533998
- Sponsor's protocol ID
- URO-04-2018
- Status last verified
- May 2018
- First submitted
- 11 May 2018
- Last updated
- 23 May 2018
- 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 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Prostate Cancer Treated With Salvage Radical Prostatectomy Following Failure of Focal Ablative Therapies
- ClinicalTrials.gov ID
- NCT03533998
- Acronym / sponsor ID
- URO-04-2018
- Conditions
- Prostatic Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Study start
- 31 May 2018 (estimated)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 23 May 2018 (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.
The ability of genomic biomarkers to Measuring tumour aggressiveness, and facilitate the selection of therapies in patients who had salvage radical prostatectomy after focal therapy and predict the risk of biochemical recurrence BCR after focal therapy or RP.
Detailed description
Between 2007 and 2017, 30 patients underwent salvage radical prostatectomy SRP for recurrent localized PCa at our institution (Institute Mutual Montsouris). Primary radiotherapy, brachytherapy and whole-gland treatments were excluded, as to evaluate the true spectrum of morphologic changes caused by the focal emerging ablative modalities. Thirteen SRP after focal ablative therapies FAT (cryotherapy or high intensity focused ultrasound- HIFU or vascular-targeted photodynamic therapy- VTP) were identified from our prospective collected database. Genitourinary pathologists were provided clinical information related to prior therapies and immunohistochemical (IHC) markers were used in the diagnosis of limited primary PC on needle biopsy when necessary. Prostatectomy specimens were processed and the number of tumor foci, size of the dominant focus and pathological stage were recorded. Residual disease was graded according to the Gleason grading system. Treatment-related histologic changes were examined.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between 2007 and 2017, 30 patients underwent salvage radical prostatectomy SRP for recurrent localized PCa at our institution (Institute Mutualiste Montsouris).
Key inclusion criteria (1 listed)
- Prostate Cancer treated with salvage radical prostatectomy following failure of focal ablative therapies
Key exclusion criteria (1 listed)
- Primary radiotherapy, brachytherapy and whole-gland treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ability of genomic biomarkers to Measuring tumour aggressiveness
Time frame: molecular analyses
Fragment of Paraffin specimen after RP will be used for the analyses by Biomarkers; MYC, PTEN protein loss, chromosome 8 alterations .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
Related trials for Prostatic Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Qusay Mandoorah, resident principal investigator
Institut Mutualiste Montsouris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms, run by Institut Mutualiste Montsouris 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 May 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qusay Mandoorah, resident (33761221259, mandoorah104@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ability of genomic biomarkers to Measuring tumour aggressiveness (time frame: molecular analyses). 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 23 May 2018.