Prostate CancerOBESITA'&PCaNCT06292897
Using Tissue-based Spatial Data to Understand How Obesity-related Tumor Metabolites Fuel Prostate Cancer Progression
An observational study of Prostate Cancer and Prostate Adenocarcinoma, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma, Prostate Neoplasm
- What is being tested?
- observational study
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2023to 15 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: patients affected bt prostate cancer both obese or not obese
Who may be able to join
- affected by prostate cancer
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Cà Granda Ospedale Maggiore Policlinico Milano
Milan
giancarlo albo, MD
About this study
Official title: Integrating Tissue-based Spatial Information to Elucidate How Obesity-induced Tumour Metabolites Drive Prostate Cancer Progression
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.
- Being tested
- observational study
- Medical subject headings
- Prostatic Neoplasms, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
observational study
| Study group | Role | What they receive |
|---|---|---|
| obese individuals [Body Mass Index (BMI) > 30 affected by prostate cancer | Not described Receives: Other: observational study | |
| normal-weight individuals [18 < BMI < 25] affected by prostate cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the protein expression of LDHA enzyme and MCT-1/-4 transporters in prostate carcinoma
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start20 Mar 2023
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council
- Responsible party
- Principal investigator, Giancarlo Albo, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292897
- Sponsor's protocol ID
- 3312
- Acronym
- OBESITA'&PCa
- Status last verified
- Feb 2024
- First submitted
- 27 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Tissue-based Spatial Information to Elucidate How Obesity-induced Tumour Metabolites Drive Prostate Cancer Progression
- ClinicalTrials.gov ID
- NCT06292897
- Acronym / sponsor ID
- OBESITA'&PCa / 3312
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- National Research Council
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese individuals [Body Mass Index (BMI) > 30 affected by prostate cancer | – | Other: observational study |
| normal-weight individuals [18 < BMI < 25] affected by prostate cancer | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients affected bt prostate cancer both obese or not obese
Key inclusion criteria (1 listed)
- affected by prostate cancer
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyobservational study | Other | obese individuals [Body Mass Index (BMI) > 30 affected by prostate cancer |
Primary outcome
Assess the protein expression of LDHA enzyme and MCT-1/-4 transporters in prostate carcinoma
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Prostate Adenocarcinoma, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giancarlo Albo, MD, (00390255034501, giancarlo.albo@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the protein expression of LDHA enzyme and MCT-1/-4 transporters in prostate carcinoma (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024; AzTrials last refreshed its copy on 27 Oct 2026.