NCT05192252

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

December 31, 2021

Last Update Submit

September 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Relationship between seminal vesicle volume measured on MRI and duration of sexual abstinence

    This outcome corresponds to the Correlation coefficient between seminal vesicle volume measured on 3 Tesla prostate MRI and duration of sexual abstinence.

    Day 1

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient performing a prostate MRI for suspected prostate cancer, between 07/06/2021 and 30/10/2022.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

RECRUITING

Related Publications (8)

  • Barrett T, Turkbey B, Choyke PL. PI-RADS version 2: what you need to know. Clin Radiol. 2015 Nov;70(11):1165-76. doi: 10.1016/j.crad.2015.06.093. Epub 2015 Jul 29.

    PMID: 26231470BACKGROUND
  • Qi X, Gao XS, Asaumi J, Zhang M, Li HZ, Ma MW, Zhao B, Li FY, Wang D. Optimal contouring of seminal vesicle for definitive radiotherapy of localized prostate cancer: comparison between EORTC prostate cancer radiotherapy guideline, RTOG0815 protocol and actual anatomy. Radiat Oncol. 2014 Dec 20;9:288. doi: 10.1186/s13014-014-0288-1.

    PMID: 25526901BACKGROUND
  • Lotti F, Corona G, Vitale P, Maseroli E, Rossi M, Fino MG, Maggi M. Current smoking is associated with lower seminal vesicles and ejaculate volume, despite higher testosterone levels, in male subjects of infertile couples. Hum Reprod. 2015 Mar;30(3):590-602. doi: 10.1093/humrep/deu347. Epub 2015 Jan 6.

    PMID: 25567620BACKGROUND
  • Lotti F, Corona G, Maseroli E, Rossi M, Silverii A, Degl'innocenti S, Rastrelli G, Forti G, Maggi M. Clinical implications of measuring prolactin levels in males of infertile couples. Andrology. 2013 Sep;1(5):764-71. doi: 10.1111/j.2047-2927.2013.00114.x.

    PMID: 23970454BACKGROUND
  • Bozkurt O, Demir O, Sen V, Esen A. Silodosin causes impaired ejaculation and enlargement of seminal vesicles in sexually active men treated for lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Urology. 2015 May;85(5):1085-1089. doi: 10.1016/j.urology.2015.01.011. Epub 2015 Mar 3.

    PMID: 25744372BACKGROUND
  • Joo I, Kim SH, Cho JY. A comparison of seminal vesicle size on CT between autosomal dominant polycystic kidney disease (ADPKD) patients and normal subjects. Acta Radiol. 2010 Jun;51(5):569-72. doi: 10.3109/02841851003652583.

    PMID: 20235741BACKGROUND
  • Barrett T, Tanner J, Gill AB, Slough RA, Wason J, Gallagher FA. The longitudinal effect of ejaculation on seminal vesicle fluid volume and whole-prostate ADC as measured on prostate MRI. Eur Radiol. 2017 Dec;27(12):5236-5243. doi: 10.1007/s00330-017-4905-x. Epub 2017 Jul 4.

    PMID: 28677052BACKGROUND
  • Yuruk E, Pastuszak AW, Suggs JM 3rd, Colakerol A, Serefoglu EC. The association between seminal vesicle size and duration of abstinence from ejaculation. Andrologia. 2017 Sep;49(7):10.1111/and.12707. doi: 10.1111/and.12707. Epub 2016 Sep 23.

    PMID: 27660049BACKGROUND

Study Officials

  • Constance MICHEL, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Constance MICHEL, MD

CONTACT

Helene BEAUSSIER, PharmD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2021

First Posted

January 14, 2022

Study Start

November 2, 2021

Primary Completion

October 15, 2023

Study Completion

December 31, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations