Targeted Biopsies in Determining Response in Patients With Prostate Cancer Undergoing High-Dose-Rate Brachytherapy
| Status: | Withdrawn |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/27/2017 |
| Start Date: | March 1, 2018 |
| End Date: | March 1, 2020 |
Feasibility of Repeat Targeted Biopsies in Patients Undergoing High-Dose-Rate Prostate Brachytherapy
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.
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.
PRIMARY OBJECTIVES:
I. Demonstrate feasibility of obtaining adequate tumor tissue from an intra-prostatic index
lesion prior to the start of androgen deprivation therapy (ADT) and again at the time of
high-dose-rate (HDR) brachytherapy.
SECONDARY OBJECTIVES:
I. Use immunohistochemistry to stain cells pre-ADT and post 2 months of ADT for markers of
non-homologous end joining and DNA double strand breaks using the following markers: Ku70,
Ku80, DNA-dependent protein kinase catalytic subunits (PKCs), gamma-histone family, member X
(H2AX).
OUTLINE:
Patients undergo biopsy at baseline before start of ADT and during brachytherapy.
I. Demonstrate feasibility of obtaining adequate tumor tissue from an intra-prostatic index
lesion prior to the start of androgen deprivation therapy (ADT) and again at the time of
high-dose-rate (HDR) brachytherapy.
SECONDARY OBJECTIVES:
I. Use immunohistochemistry to stain cells pre-ADT and post 2 months of ADT for markers of
non-homologous end joining and DNA double strand breaks using the following markers: Ku70,
Ku80, DNA-dependent protein kinase catalytic subunits (PKCs), gamma-histone family, member X
(H2AX).
OUTLINE:
Patients undergo biopsy at baseline before start of ADT and during brachytherapy.
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
We found this trial at
1
site
Los Angeles, California 90095
Principal Investigator: Mitchell R. Kamrava
Phone: 310-825-9775
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