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Mapping the tumor microenvironment to predict prostate cancer therapy outcomes

NCT ID NCT07795177

Knowledge-focused Sponsor: Anhui Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This study investigates whether detailed molecular mapping of prostate tumors can predict how well men with metastatic hormone-sensitive prostate cancer respond to androgen deprivation therapy (ADT) combined with second-generation hormonal agents like abiraterone or enzalutamide. Researchers will analyze tumor tissue samples using advanced techniques to examine genetic mutations, gene activity, and protein expression in the tumor and its surroundings. The goal is to identify molecular patterns that correlate with treatment outcomes, potentially leading to more personalized therapy decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ADT plus abiraterone or other ARPIs (apalutamide, enzalutamide, rezvilutamide, darolutamide)
What this could lead to
If successful, this could lead to a test that predicts which men with metastatic hormone-sensitive prostate cancer will benefit most from ADT plus ARPI therapy, enabling more personalized treatment.
What could go wrong
This is a small, early-phase study. The molecular features may not reliably predict treatment response, and the findings may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age \> 18 years and \< 85 years. 2. Histopathologically confirmed prostate adenocarcinoma, ductal adenocarcinoma, or intraductal carcinoma. 3. Imaging evidence of definite distant metastases (according to RECIST criteria). 4. Pre-biopsy PSA ≥ 20 ng/mL or Gleason score ≥ 4+4. 5. No prior hormonal therapy or other systemic anti-tumor regimens. 6. ECOG performance status 0-2, with an estimated life expectancy \> 6 months. 7. Adequate organ function.h. Ability and willingness to provide written informed consent, and capability to comply with the study visit schedule. Exclusion Criteria: 1. Histopathological diagnosis of neuroendocrine or small cell prostate cancer. 2. No definite distant metastases detected on imaging. 3. Prior history of anti-tumor therapy (including neoadjuvant, adjuvant, or other treatments). 4. Submitted biopsy samples fail to meet quality control requirements. 5. Concurrent severe endocrine or metabolic disorders, or other severe digestive system diseases. 6. Concurrent chronic hepatitis, cirrhosis, chronic nephritis, renal insufficiency, or other relevant conditions. 7. History of immunodeficiency or organ transplantation. 8. History of other concurrent malignancies. 9. Concurrent enrollment in other clinical trials. 10. Other conditions that the investigator deems unsuitable for study enrollment.

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic hormone sensitive prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Universitythe First Affiliatedhospital of Anhuimedical

    Hefei, Anhui, 230022, China

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