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Biomarkers in Prostate Cancer Treated With SRP Following Failure of FAT

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ClinicalTrials.gov Identifier: NCT03533998
Recruitment Status : Not yet recruiting
First Posted : May 23, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Mutualiste Montsouris

Brief 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.

Condition or disease
Prostatic Neoplasms

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Biomarkers in Prostate Cancer Treated With Salvage Radical Prostatectomy Following Failure of Focal Ablative Therapies
Estimated Study Start Date : May 31, 2018
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer




Primary Outcome Measures :
  1. 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

    .



Biospecimen Retention:   Samples With DNA
FFPE tumor tissue of radical prostatectomy.


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   prostate
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Between 2007 and 2017, 30 patients underwent salvage radical prostatectomy SRP for recurrent localized PCa at our institution (Institute Mutualiste Montsouris).
Criteria

Inclusion Criteria:

  • Prostate Cancer treated with salvage radical prostatectomy following failure of focal ablative therapies

Exclusion Criteria:

  • Primary radiotherapy, brachytherapy and whole-gland treatments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533998


Contacts
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Contact: Qusay Mandoorah, resident 33761221259 mandoorah104@gmail.com
Contact: Rafael Sanchez-Salas, surgeon 331 rafael.sanchez-salas@imm.fr

Locations
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France
Institut Mutualiste Montsouris
Paris, France, 75014
Sponsors and Collaborators
Institut Mutualiste Montsouris
Investigators
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Principal Investigator: Qusay Mandoorah, resident Institut Mutualiste Montsouris

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Responsible Party: Institut Mutualiste Montsouris
ClinicalTrials.gov Identifier: NCT03533998     History of Changes
Other Study ID Numbers: URO-04-2018
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases