NCT06292897

Brief Summary

Evaluate the protein expression of lactate dehydrogenase enzyme (LDHA) and MCT-1/-4 transporters, involved in lactate synthesis and transport, in prostate carcinoma tissues from severely overweight/obese (BMI \> 27.5) and non-severely overweight/normoweight (BMI \< 27.5) patients affected by prostate carcinoma. ii. Characterize the immune infiltrate in the prostate carcinoma of the aforementioned patients. iii. Assess the association between intra-tumoral lactate accumulation (using LDHA and MCT-4 protein expression levels as readouts) and alterations in the tumor immune microenvironment and/or deregulation of relevant oncogenic pathways.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
6mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress88%
Mar 2023Jan 2027

Study Start

First participant enrolled

March 20, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2027

Last Updated

March 5, 2024

Status Verified

February 1, 2024

Enrollment Period

3.5 years

First QC Date

February 27, 2024

Last Update Submit

February 27, 2024

Conditions

Prostate CancerProstate AdenocarcinomaProstate NeoplasmProstatic NeoplasmObesity

Outcome Measures

Primary Outcomes (1)

  • Assess the protein expression of LDHA enzyme and MCT-1/-4 transporters in prostate carcinoma

    4 years

Study Arms (2)

obese individuals [Body Mass Index (BMI) > 30 affected by prostate cancer

Other: observational study

normal-weight individuals [18 < BMI < 25] affected by prostate cancer

Interventions

observational studyOTHER

observational study

obese individuals [Body Mass Index (BMI) > 30 affected by prostate cancer

Eligibility Criteria

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

patients affected bt prostate cancer both obese or not obese

You may qualify if:

  • affected by prostate cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Cà Granda Ospedale Maggiore Policlinico Milano

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic NeoplasmsObesity

Interventions

Observation

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Giancarlo Albo, MD,

CONTACT

00390255034501giancarlo.albo@policlinico.mi.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

February 27, 2024

First Posted

March 5, 2024

Study Start

March 20, 2023

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

January 15, 2027

Last Updated

March 5, 2024

Record last verified: 2024-02

Locations

IT(1)