High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma

Launched by JONSSON COMPREHENSIVE CANCER CENTER · Jun 22, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat prostate cancer using two types of radiation therapy: high dose-rate brachytherapy and stereotactic body radiotherapy. Brachytherapy involves placing a small amount of radioactive material directly into or near the tumor to attack cancer cells, while stereotactic body radiotherapy uses advanced technology to precisely target the tumor with radiation. The goal is to effectively kill cancer cells while minimizing damage to healthy tissue, and the trial is currently recruiting male participants aged 18 and older who have been diagnosed with certain stages of prostate adenocarcinoma.

To be eligible for the trial, participants need to have a confirmed diagnosis of intermediate to high-risk prostate cancer and no evidence of the disease spreading beyond the prostate. Other criteria include being in good overall health and able to understand and sign a consent form. If you or a loved one participate in this trial, you can expect to receive targeted radiation treatment that may be more efficient and less harmful than traditional methods. This trial is a chance to be part of innovative research that could improve prostate cancer treatments in the future.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Ability to understand a written informed consent document, and the willingness to sign it
• • Age \>= 18 years
• • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• • History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration
• • Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA \> 10, and/or Gleason score \>= 7
• • No evidence of disease beyond the prostate and/or seminal vesicles (i.e., no suspicious pelvic lymph nodes or presence of metastatic disease outside the pelvis)
• • Prostate size =\< 60cc
• • International Prognostic Scoring System (IPSS) score =\< 15
• • Able to safely receive moderate sedation or general anesthesia
• Exclusion Criteria:
• • Patients with neuroendocrine or small cell carcinoma of the prostate
• • Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years
• • Regional lymph node involvement
• • Evidence of distant metastases
• • Previous radical surgery (prostatectomy) or cryosurgery or high-intensity focused ultrasound for prostate cancer
• • Previous pelvic irradiation or prostate brachytherapy
• • Previous or concurrent cytotoxic chemotherapy for prostate cancer
• • Patients with history of inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), high predisposition for radio-toxicity compared to general population (i.e., ataxia telangiectasia), or at risk for major bowel surgery
• • Transurethral resection of the prostate (TURP) procedure within 6 months of radiation treatment