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Correlation Between Seminal Vesicle Size and Duration of Sexual Abstinence (AbsVS)

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ClinicalTrials.gov Identifier: NCT05192252
Recruitment Status : Recruiting
First Posted : January 14, 2022
Last Update Posted : February 11, 2022
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:

The seminal vesicles (SV) are glands that open into the prostatic urethra and secrete seminal fluid, which makes up 50 to 80% of semen. They play an essential role in the male reproductive function. In adults, the size of a seminal vesicle varies from one individual to another. On average, it is 5 to 6 cm long, 1.5 cm wide and 0.5 cm thick. It has a close anatomical relationship with Walsh's vascular-nervous pedicle, which extends the sacro-genital-pubic blades, and is responsible for erection. The reference treatment for localized prostate cancer can consist of two alternatives: either intensity-modulated pelvic radiotherapy with treatment of the entire prostate volume and VS, or surgical removal of the vesiculo-prostatic block in monobloc. It is therefore always extended to the VS.

Magnetic resonance imaging (MRI) is now routinely performed for the initial workup of prostate cancer, with a diagnostic and prognostic role, as invasion of the VS by cancer is recognized as a poor prognostic factor. Some radiology centers recommend 3 days of sexual abstinence to allow a proper seminal vesicle study. Various factors, such as serum testosterone levels, autosomal dominant polycystic kidney disease, smoking, and certain drugs such as SILODOSINE, have been identified as factors that can independently vary seminal vesicle size.

The duration of sexual abstinence since the last ejaculation also appears to be correlated with seminal vesicle volume. Two recent studies found a correlation between the duration of sexual abstinence and seminal vesicle volume measured on MRI in a young population (median age 35.9 and 46.45 years). This population is not superimposable to that of patients managed for prostate cancer whose average age at diagnosis is 70 years.

However, the control and knowledge of the volume of VS, in this specific population, could have an interest in the treatment of prostate cancer:

  • In case of pelvic radiotherapy in order to limit the volume of the organ to be irradiated, the toxicity induced to the adjacent organs being directly associated to the delivered dose.
  • In case of radical vesiculo-prostatectomy, by surgical way, the lateral dissection of the vasculo-nerveous bands is made more difficult in case of voluminous seminal vesicles with an increased risk of nerve damage.

Investigators hypothesize that the volume of the VS is correlated with the duration of abstinence. Thus, evacuation of seminal fluid by ejaculation at a defined time before curative treatment of prostate cancer, could improve the functional results of pelvic radiotherapy or surgery.


Condition or disease
Suspected Prostate Cancer

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Correlation Between Seminal Vesicle Size and Duration of Sexual Abstinence
Actual Study Start Date : November 2, 2021
Estimated Primary Completion Date : October 10, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Relationship between seminal vesicle volume measured on MRI and duration of sexual abstinence [ Time Frame: Day 1 ]
    This outcome corresponds to the Correlation coefficient between seminal vesicle volume measured on 3 Tesla prostate MRI and duration of sexual abstinence.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient performing a prostate MRI for suspected prostate cancer, between 07/06/2021 and 30/10/2022.
Criteria

Inclusion Criteria:

  • Patient whose age ≥ 45 years
  • French speaking patient
  • Patient performing a prostate MRI for suspected prostate cancer

Exclusion Criteria:

  • History of curative treatment for prostate cancer (radical prostatectomy, external radiotherapy, brachytherapy, HIFU, cryotherapy)
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of his or her data for this research

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): NCT05192252


Contacts
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Contact: Constance MICHEL, MD 144127818 ext +33 cmichel@ghpsj.fr
Contact: Helene BEAUSSIER, PharmD, PhD 0144127883 ext +33 crc@ghpsj.fr

Locations
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France
Groupe Hospitalier Paris Saint-Joseph Recruiting
Paris, France, 75014
Contact: Constance P MICHEL, MD         
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Principal Investigator: Constance MICHEL, MD Groupe Hospitalier Paris Saint Joseph
Publications:

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT05192252    
Other Study ID Numbers: AbsVS
First Posted: January 14, 2022    Key Record Dates
Last Update Posted: February 11, 2022
Last Verified: December 2021

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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
Prostatic Diseases