Metastatic Hormone-Sensitive Prostate CanceNCT07154914
A Novel Insight Into CRPC Progression and Immune: Evidence From Single-cell Spatial Transcriptome Multi-omics
An observational study of Metastatic Hormone-Sensitive Prostate Cance, run by Anhui Medical University.
Trial summary
This study will follow patients with metastatic hormone-sensitive prostate cancer (mHSPC) who receive androgen deprivation therapy (ADT) combined with different treatments. Prostate cancer is a common cancer in men, and many patients in China are diagnosed at an advanced stage. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Metastatic Hormone-Sensitive Prostate Cance
- What is being tested?
- Abiraterone + ADT
- How many people
- 396 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Sep 2026
- 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 to 85 years
- Men only
- Adult, Older adult
Study population: Male patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC), recruited from multiple centers in China. Eligible patients are treatment-naïve and will receive androgen deprivation therapy (ADT) combined with different regimens according to real-world clinical practice.
Who may be able to join
- Male patients, age >18 and <85 years.
- Histologically confirmed prostate adenocarcinoma, ductal adenocarcinoma, or intraductal carcinoma.
- Evidence of distant metastases by imaging (according to RECIST criteria).
- No prior systemic therapy for prostate cancer (no ADT or other systemic treatments).
- ECOG performance status 0-2 and estimated life expectancy >6 months.
- Adequate organ function as indicated by:
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- Hemoglobin ≥ 90 g/L
- ANC ≥ 1.5 × 10^9/L
- Platelet count ≥ 75 × 10^9/L
- WBC ≥ 3 × 10^9/L ⑤ Total bilirubin ≤ ULN ⑥ ALT/AST ≤ 2.5 × ULN ⑦ Creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula)
- INR ≤ 1.5 or PT < 4 sec above ULN
- Ability to provide written informed consent.
Who cannot join
- Histological diagnosis of neuroendocrine or small-cell prostate cancer.
- No evidence of distant metastases on imaging.
- Prior systemic therapy for prostate cancer (neoadjuvant, adjuvant, or systemic).
- Severe endocrine, metabolic, gastrointestinal, hepatic, or renal disease (including chronic hepatitis, cirrhosis, chronic nephritis, or renal failure).
- History of immunodeficiency, including HIV positivity, congenital immunodeficiency, or organ transplantation.
- History of other malignancies (except non-melanoma skin cancer).
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- Concurrent participation in another clinical trial.
- Inability to provide clinical information or anticipated loss to follow-up.
- Any condition deemed unsuitable for study participation by the investigator.
About this study
Official title: Mapping Prostate Cancer Evolution and Therapy Resistance With Single-Cell Technologies
This study will follow patients with metastatic hormone-sensitive prostate cancer (mHSPC) who receive androgen deprivation therapy (ADT) combined with different treatments. Prostate cancer is a common cancer in men, and many patients in China are diagnosed at an advanced stage. While ADT alone has been the standard treatment, most patients eventually progress to castration-resistant disease.
New medicines such as abiraterone, enzalutamide, apalutamide, darolutamide, and chemotherapy like docetaxel have shown survival benefits when added to ADT. This study aims to observe how different ADT-based combinations work in real-world practice and whether genetic differences affect outcomes.
About 396 patients will be enrolled and followed until disease progression or death. The results will help identify which treatments are most effective and guide more personalized care for men with advanced prostate cancer.
- Being tested
- Abiraterone + ADT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone + ADTDrug
Patients receiving androgen deprivation therapy (ADT) combined with abiraterone. Abiraterone is a CYP17A1 inhibitor used in combination with prednisone and ADT for metastatic hormone-sensitive prostate cancer (mHSPC). This combination is given in real-world practice according to clinical guidelines.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression to castration-resistant prostate cancer (CRPC)
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Hormone-Sensitive Prostate CanceStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 396 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Zhang Meng, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154914
- Sponsor's protocol ID
- AYFY2025-08-27
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Prostate Cancer Evolution and Therapy Resistance With Single-Cell Technologies
- ClinicalTrials.gov ID
- NCT07154914
- Acronym / sponsor ID
- AYFY2025-08-27
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 4 Sep 2025 (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.
This study will follow patients with metastatic hormone-sensitive prostate cancer (mHSPC) who receive androgen deprivation therapy (ADT) combined with different treatments. Prostate cancer is a common cancer in men, and many patients in China are diagnosed at an advanced stage. While ADT alone has been the standard treatment, most patients eventually progress to castration-resistant disease.
New medicines such as abiraterone, enzalutamide, apalutamide, darolutamide, and chemotherapy like docetaxel have shown survival benefits when added to ADT. This study aims to observe how different ADT-based combinations work in real-world practice and whether genetic differences affect outcomes.
About 396 patients will be enrolled and followed until disease progression or death. The results will help identify which treatments are most effective and guide more personalized care for men with advanced prostate cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Male patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC), recruited from multiple centers in China. Eligible patients are treatment-naïve and will receive androgen deprivation therapy (ADT) combined with different regimens according to real-world clinical practice.
Key inclusion criteria (12 listed)
- Male patients, age >18 and <85 years.
- Histologically confirmed prostate adenocarcinoma, ductal adenocarcinoma, or intraductal carcinoma.
- Evidence of distant metastases by imaging (according to RECIST criteria).
- No prior systemic therapy for prostate cancer (no ADT or other systemic treatments).
- ECOG performance status 0-2 and estimated life expectancy >6 months.
Key exclusion criteria (9 listed)
- Histological diagnosis of neuroendocrine or small-cell prostate cancer.
- No evidence of distant metastases on imaging.
- Prior systemic therapy for prostate cancer (neoadjuvant, adjuvant, or systemic).
- Severe endocrine, metabolic, gastrointestinal, hepatic, or renal disease (including chronic hepatitis, cirrhosis, chronic nephritis, or renal failure).
- History of immunodeficiency, including HIV positivity, congenital immunodeficiency, or organ transplantation.
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 |
|---|---|---|
| Abiraterone + ADTPatients receiving androgen deprivation therapy (ADT) combined with abiraterone. Abiraterone is a CYP17A1 inhibitor used in combination with prednisone and ADT for metastatic hormone-sensitive prostate cancer (mHSPC). This combination is given in real-world practice according to clinical guidelines. | Drug | – |
Primary outcome
Time to progression to castration-resistant prostate cancer (CRPC)
Time frame: Up to 36 months
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 4 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Hormone-Sensitive Prostate Cance, run by Anhui Medical University.
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 12 inclusion and 9 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: opening soon, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to progression to castration-resistant prostate cancer (CRPC) (time frame: Up to 36 months). 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 4 Sep 2025.