NCT05530395

Brief Summary

Despite large amounts of basic-science data supporting a role for androgens in PCa pathogenesis, there are conflicting clinical data on the role of endogenous testosterone in human de novo PCa pathogenesis. The investigators hypothesize that lower baseline serum testosterone is significantly associated with worse clinical outcomes in mHSPC patients undergoing continuous medical castration

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

September 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

2 years

First QC Date

September 2, 2022

Last Update Submit

September 9, 2022

Conditions

Prostate Cancer Metastatic

Keywords

Testosterone, biomarker

Outcome Measures

Primary Outcomes (2)

  • Early treatment failure

    Proportion of patients with PSA progression or death from PCa within 12 months after initiation of treatment.

    1 year

  • PSA response

    Lowest PSA (nadir) reached after initiation of treatment

    6 months

Secondary Outcomes (4)

  • Testosterone response.

    6 months

  • Biochemical progression-free survival (bPFS)

    1 year

  • Radiologic progression-free survival (rPFS)

    1 year

  • Time to CRPC

    1 year

Interventions

Testosterone levelsDIAGNOSTIC_TEST

Blood sample to determine testosterone levels

Eligibility Criteria

Age18 Years - 89 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Metastatic hormone sensitive prostate cancer (mHSPC) patients diagnosed by any imaging test (at least CT and/or bone scan).

You may qualify if:

  • Metastatic hormone sensitive prostate cancer (mHSPC) patients diagnosed by any imaging test (at least CT and bone scan) including:
  • Any newly diagnosed mHSPC with no prior treatments.
  • Primarily treated PCa that have progressed to mHSPC with no prior ADT in the last 2 years.
  • Patients receiving ADT + EBRT as primary treatment will also be included.
  • Patients who agree to be followed prospectively according to routine clinical practice in the context of this study.

You may not qualify if:

  • Any prior androgen deprivation therapy (ADT) scheme 2 years before recruitment. - Any prior testosterone replacement therapy scheme 2 years before recruitment.
  • Previous intermittent ADT schemes.
  • Prior testicular excision surgery.
  • Absence or testicular atrophy from any cause.
  • Whenever further prospective clinical follow-up is not possible or patient do not accept follow-up in the context of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Universitario Reina Sofía

Córdoba, Andalusia, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Andalusia, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, Spain

Location

Related Publications (4)

  • Michaud JE, Billups KL, Partin AW. Testosterone and prostate cancer: an evidence-based review of pathogenesis and oncologic risk. Ther Adv Urol. 2015 Dec;7(6):378-87. doi: 10.1177/1756287215597633.

    PMID: 26622322BACKGROUND

  • Pierorazio PM, Ferrucci L, Kettermann A, Longo DL, Metter EJ, Carter HB. Serum testosterone is associated with aggressive prostate cancer in older men: results from the Baltimore Longitudinal Study of Aging. BJU Int. 2010 Mar;105(6):824-9. doi: 10.1111/j.1464-410X.2009.08853.x. Epub 2009 Sep 14.

    PMID: 19751256BACKGROUND

  • Yano M, Imamoto T, Suzuki H, Fukasawa S, Kojima S, Komiya A, Naya Y, Ichikawa T. The clinical potential of pretreatment serum testosterone level to improve the efficiency of prostate cancer screening. Eur Urol. 2007 Feb;51(2):375-80. doi: 10.1016/j.eururo.2006.08.047. Epub 2006 Sep 12.

    PMID: 17005316BACKGROUND

  • Rajek NJ. Developing an evening clinical experience for baccalaureate community health nursing students. J Nurs Educ. 1987 May;26(5):197-200. doi: 10.3928/0148-4834-19870501-07.

    PMID: 3035140BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

Study Officials

  • Ignacio Puche

    Fundación para la Investigación Biosanitaria de Andalucía Oriental (FIBAO)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ignacio Puche Sanz

CONTACT

0034 958 023 158naho.puchesanz@gmail.com

Soraya Santana

CONTACT

0034 958 023 158ssantana@fibao.es

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 7, 2022

Study Start

January 1, 2023

Primary Completion

January 1, 2025

Study Completion

January 1, 2026

Last Updated

September 14, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(3)