Targeted Biopsies in Determining Response in Patients With Prostate Cancer Undergoing High-Dose-Rate Brachytherapy

Jonsson Comprehensive Cancer Center

Status: Withdrawn

Conditions: Stage III Prostate Adenocarcinoma

Treatments: Other: Laboratory Biomarker Analysis; Procedure: Biopsy of Prostate

Study type: Interventional

Funder types: Other

Identifiers

NCT02597894

NCI-2015-01737 (Registry Identifier)

15-000360 (Other Identifier)

JCCCID562 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Prostate biopsy

Other group

Description:

Patients undergo two biopsies, the first at baseline before start of ADT and the second two months later during brachytherapy.

Treatment:

Other: Laboratory Biomarker Analysis

Procedure: Biopsy of Prostate