Clinical trial · Observational
Cell-Free DNA and RNA in Blood fromMetastatic Prostate Cancer Patients
Studies of Cell-Free DNA and RNA in Blood From Patients Being Treated for Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
This research trial studies cell-free deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) in blood from patients with prostate cancer that does not respond to hormone therapy and has spread to other places in the body. Studying samples of blood from patients with prostate cancer may help doctors to learn more about the changes that occur in tumor cells over time and how they become resistant to anti-cancer drugs.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone-Resistant Prostate Cancer | — | UNRESOLVED | — |
| Metastatic Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytology Specimen Collection Procedure | Other | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-Correlative (blood collection)
- description
- Patients undergo blood collection every 4-12 weeks during ADT, abiraterone, enzalutamide, or docetaxel treatment. Patients switched from ADT to either abiraterone or enzalutamide during the study will undergo phlebotomy every 6-12 weeks. Samples are analyzed for cfRNA, and cfDNA, AR-V7, and other AR-Vs via quantitative RT-PCR.
- interventionNames
- Other: Cytology Specimen Collection Procedure
- Other: Laboratory Biomarker Analysis
Primary outcomes (3)
- measure
- Change in AR-V7 presence
- timeFrame
- Baseline to 3 years
- description
- Each of the 4 longitudinal cohorts will be analyzed separately (at least initially). Kaplan-Meier-like curves (likely adjusted for interval censoring) will be used to display the development of AR-V7 positivity. To complement the analysis of Cohort A, an exact logistic regression analysis will be used with the data from Cohort X with AR-V7 splice variant positivity as the dependent variable and time since start of ADT as the independent variable. Logistic regression will be used to assess the association between AR-V7 status at start of treatment and overall response to treatment.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* A diagnosis of histologically confirmed prostate adenocarcinoma and falling into one of the following 5 groups:
* Currently receiving ADT (previously untreated for metastatic disease)
* These patients will be grouped into 3 cohorts: having received ADT for 3-6 months; for 1-2 years; and for \> 3 years
* Scheduled to begin treatment with ADT (previously untreated for metastatic disease)
* Scheduled to begin treatment with enzalutamide (castration resistant / has received ADT / may have received abiraterone)
* Scheduled to begin treatment with abiraterone (castration resistant / has received ADT / may have received enzalutamide)
* Scheduled to begin treatment with docetaxel (castration resistant / has received ADT / has received enzalutamide and/or abiraterone)
* Have been diagnosed with either hormone-naive or castrate-resistant metastatic disease
* Ability and willingness to provide written and informed consent
Exclusion Criteria:
* Patients who receive combined ADT with docetaxel for hormone-naive metastatic prostate cancer
* Patients on intermittent ADTReferences
Publications (0)
Data not yet available