Clinical trial · Interventional
Targeted Biopsies in Determining Response in Patients With Prostate Cancer Undergoing High-Dose-Rate Brachytherapy
Feasibility of Repeat Targeted Biopsies in Patients Undergoing High-Dose-Rate Prostate Brachytherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): P. I. left the Institution. Study never opened
Summary
Brief summary (as posted)
This pilot clinical trial studies targeted biopsies in determining response in patients with prostate cancer undergoing high-dose-rate brachytherapy (a type of radiation therapy in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor). Studying tumor tissue obtained before and after treatment may help doctors understand changes in a pathway that looks at how deoxyribonucleic acid (DNA) is repaired after it is damaged and to see if there are differences in the prostate tissue prior to and after starting androgen deprivation therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage III Prostate Adenocarcinoma | Prostate Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy of Prostate | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Prostate biopsy
- description
- Patients undergo two biopsies, the first at baseline before start of ADT and the second two months later during brachytherapy.
- interventionNames
- Procedure: Biopsy of Prostate
- Other: Laboratory Biomarker Analysis
Primary outcomes (1)
- measure
- Changes in DNA damage repair pathways
- timeFrame
- Two months
- description
- The prostate biopsy sample at baseline and at the time of brachytherapy (approximately two months later) will be examined to determine if prostate cancer is in the core and if at least 20% of the core has prostate cancer in it.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed primary adenocarcinoma of the prostate * National Comprehensive Cancer Network (NCCN) high risk disease (cT3 or Gleason score 8-10 or prostate specific antigen \[PSA\] \> 20) * Not currently on ADT * Magnetic resonance imaging (MRI) or transrectal doppler ultrasound demonstrating at least one target lesion * Karnofsky performance status (KPS) \>= 70 or Eastern Cooperative Oncology Group (ECOG) = 2 * Understands the trial and procedure and is willing and able to sign the informed consent form Exclusion Criteria: * Patient is unable to receive high dose rate prostate brachytherapy * Patient is unable to have a MRI or transrectal ultrasound * Refusal to sign the informed consent * Patients who are participating in a concurrent treatment protocol
References
Publications (0)
Data not yet available