WithdrawnNot Applicable

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

Stopped: P. I. left the Institution. Study never opened

United States0Started 2018-03-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Changes in DNA damage repair pathways

Timeframe: Two months

Trial details

NCT IDNCT02597894

SponsorJonsson Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-03-01