A Prospective Study Based on Spatial Multi-omics to Predict the Efficacy of ADT Combined With Second-generation Novel Hormonal Agents in Metastatic Hormone-sensitive Prostate Cancer.
2026년 8월 26일 업데이트: Sheng Tai, Anhui Medical University
A Prospective Study Based on Spatial Multi-Omics for Predicting the Efficacy of Androgen Deprivation Therapy Combined With Second-Generation Novel Endocrine Therapeutic Agents in Metastatic Hormone-Sensitive Prostate Cancer.
This study plans to enroll patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) and conduct a prospective, single-center, observational study.
By performing whole-exome sequencing (WES), Xenium spatial transcriptomics, and PhenoCycler-Fusion spatial single-cell proteomics (PCF analysis) on tumor tissue samples, we aim to comprehensively delineate the molecular landscape of patients with different spatial multi-omic profiles in the real-world setting.
We will investigate the associations between these molecular features and differential treatment responses to various therapeutic regimens, and further construct predictive models of treatment response.
Ultimately, this will enable precise evaluation of treatment outcomes across distinct molecular subtypes and provide evidence to support individualized precision diagnostics and therapeutics for patients with mHSPC.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
상세 설명
1、Baseline sample collection: Tumor tissues will be collected via prostate biopsy from enrolled patients.
The specimens will be tripartite: one aliquot for standard histopathology, one for WES, and one for spatial multi-omic profiling (Xenium and PhenoCycler-Fusion).2、Follow-up: Patients will be assessed every 3 months during therapy, with CBC, biochemistry, sex hormones, and serum PSA.
Prostate mpMRI will be repeated every 3 months.
PSA testing frequency may be modified if PSA progression occurs.
Follow-up continues until CRPC development or death.3、（1）Primary:
Build a prognostic model integrating Xenium, WES, and PCF data.（2）Secondary:
bPFS and OS.（3）Progression: PSA rise to ≥0.2 ng/mL confirmed on repeat testing after prior undetectable levels.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
40
단계
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Sheng Tai, M.D.
- 전화번호: 0551-62922234 86-18355159268
- 이메일: Taishengwk@163.com
연구 연락처 백업
- 이름: Hongzhi Wang, M.D.
- 전화번호: 0551-62922234 86-18846156838
- 이메일: wanghongzhi0830@163.com
연구 장소
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Anhui
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Hefei, Anhui, 중국, 230022
- Universitythe First Affiliatedhospital of Anhuimedical
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연락하다:
- Sheng Tai, M.D.
- 전화번호: 0551-62922234 86-18355159268
- 이메일: Taishengwk@163.com
-
연락하다:
- Hongzhi Wang, M.D.
- 전화번호: 0551-62922234 86-18846156838
- 이메일: wanghongzhi0830@163.com
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수석 연구원:
- Sheng Tai, M.D.
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Age > 18 years and < 85 years.
- Histopathologically confirmed prostate adenocarcinoma, ductal adenocarcinoma, or intraductal carcinoma.
- Imaging evidence of definite distant metastases (according to RECIST criteria).
- Pre-biopsy PSA ≥ 20 ng/mL or Gleason score ≥ 4+4.
- No prior hormonal therapy or other systemic anti-tumor regimens.
- ECOG performance status 0-2, with an estimated life expectancy > 6 months.
- Adequate organ function.h. Ability and willingness to provide written informed consent, and capability to comply with the study visit schedule.
Exclusion Criteria:
- Histopathological diagnosis of neuroendocrine or small cell prostate cancer.
- No definite distant metastases detected on imaging.
- Prior history of anti-tumor therapy (including neoadjuvant, adjuvant, or other treatments).
- Submitted biopsy samples fail to meet quality control requirements.
- Concurrent severe endocrine or metabolic disorders, or other severe digestive system diseases.
- Concurrent chronic hepatitis, cirrhosis, chronic nephritis, renal insufficiency, or other relevant conditions.
- History of immunodeficiency or organ transplantation.
- History of other concurrent malignancies.
- Concurrent enrollment in other clinical trials.
- Other conditions that the investigator deems unsuitable for study enrollment.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
1
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Newly diagnosed mHSPC patients who meet the inclusion criteria
Eligible patients will be enrolled after providing written informed consent.
Individualized therapy (ADT plus abiraterone or other ARPIs) will be prescribed by the investigators according to each patient's financial situation, drug availability, and clinical needs, with regular follow-ups performed following routine real-world practice
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The spatial heterogeneity of the tumor microenvironment in mHSPC-encompassing immune cell infiltration patterns, tumor-stroma interface features, and the regional activation status of critical signaling pathways-is intimately linked to clinical outcomes with ADT plus ARPI therapy.
Through comprehensive spatial multi-omic profiling, these spatial attributes can be systematically dissected to uncover pivotal predictive biomarkers, facilitate the development of accurate response prediction models, and ultimately guide personalized therapeutic strategies for patients with mHSPC
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Biochemical Progression-Free Survival (bPFS)
기간: From treatment initiation until biochemical progression or last follow-up, assessed every 3 months (±1 month) for up to 24 months.
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Time from initiation of ADT plus ARPI therapy to biochemical progression or death from any cause, whichever occurs first.
Biochemical progression is defined as a PSA rise to ≥0.2 ng/mL after having reached an undetectable level, confirmed by a second measurement at least 2 weeks apart.
Participants without an event will be censored at the date of last follow-up.
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From treatment initiation until biochemical progression or last follow-up, assessed every 3 months (±1 month) for up to 24 months.
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Overall Survival (OS)
기간: From treatment initiation until death or last follow-up, assessed up to 24 months.
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Time from treatment initiation to death from any cause.
Participants alive or lost to follow-up will be censored at the date last known alive.
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From treatment initiation until death or last follow-up, assessed up to 24 months.
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mutation Frequency of Key Genes Assessed by Whole-Exome Sequencing (WES)
기간: Baseline (at enrollment, from biopsy tissue).
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Baseline tumor tissue from prostate biopsy will be analyzed by WES.
The mutation status (including variant allele frequency) of AR, TP53, PTEN, RB1, and other relevant genes will be reported as the proportion of participants with each mutation.
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Baseline (at enrollment, from biopsy tissue).
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Spatial Gene Expression Signatures Measured by Xenium Platform
기간: Baseline (at enrollment).
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Baseline biopsy tissue will be processed for Xenium in situ spatial transcriptomics.
The average expression levels of a pre-specified gene panel (including AR-signaling and immune-related genes) in tumor, immune, and stromal compartments will be reported.
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Baseline (at enrollment).
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Spatial Protein Marker Expression Measured by PhenoCycler-Fusion (PCF)
기간: Baseline (at enrollment).
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Using cyclic immunofluorescence on baseline biopsy tissue, the platform quantifies the density (cells/mm²) and proportion of positive cells for a panel of protein markers (e.g., AR, PSMA, PD-L1, CD8, CD68) within the tumor microenvironment.
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Baseline (at enrollment).
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Area Under the Receiver Operating Characteristic Curve (AUC) of the Multi-omics Prediction Model for 6-Month Undetectable PSA（ PSA <0.2 ng/mL ）
기간: Baseline data used to predict outcome at 6 months after treatment initiation.
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Baseline WES, Xenium, and PCF data will be integrated using a machine-learning algorithm (e.g., random forest or LASSO-Cox) to build a model predicting Undetectable PSA at 6 months ( defined as serum PSA <0.2 ng/mL confirmed at two consecutive visits).
Model performance will be evaluated by cross-validation, and the mean AUC with 95% confidence interval will be reported, along with sensitivity, specificity, and positive predictive value.
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Baseline data used to predict outcome at 6 months after treatment initiation.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Sheng Tai, M.D., The First Affiliated Hospital of Anhui Medical University
- 수석 연구원: Hongzhi Wang, M.D., The First Affiliated Hospital of Anhui Medical University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 10월 1일
기본 완료 (추정된)
기본 완료
2028년 4월 30일
연구 완료 (추정된)
연구 완료
2028년 6월 30일
연구 등록 날짜
최초 제출
최초 제출
2026년 8월 13일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 8월 26일
처음 게시됨 (실제)
처음 게시됨
2026년 8월 31일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 31일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 26일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- KY2026-09-81
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
IPD 계획 설명
Genetic information from patients will be analyzed.The research involves genetic/genomic profiling of patient samples.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .