RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial investigates the effect of high dose-rate brachytherapy and stereotactic body radiotherapy in treating patients with prostate adenocarcinoma. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.

Official Title

Phase 2 Study of High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for Intermediate and High Risk Localized Prostate Adenocarcinoma (HYDRA)

Quick Facts

Study Start:2021-08-20
Study Completion:2026-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04945642

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to understand a written informed consent document, and the willingness to sign it
  2. * Age \>= 18 years
  3. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  4. * History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration
  5. * Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA \> 10, and/or Gleason score \>= 7
  6. * 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)
  7. * Prostate size =\< 60cc
  8. * International Prognostic Scoring System (IPSS) score =\< 15
  9. * Able to safely receive moderate sedation or general anesthesia
  1. * Patients with neuroendocrine or small cell carcinoma of the prostate
  2. * Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years
  3. * Regional lymph node involvement
  4. * Evidence of distant metastases
  5. * Previous radical surgery (prostatectomy) or cryosurgery or high-intensity focused ultrasound for prostate cancer
  6. * Previous pelvic irradiation or prostate brachytherapy
  7. * Previous or concurrent cytotoxic chemotherapy for prostate cancer
  8. * 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
  9. * Transurethral resection of the prostate (TURP) procedure within 6 months of radiation treatment

Contacts and Locations

Study Contact

Vince Basehart
CONTACT
310-267-8954
vbasehart@mednet.ucla.edu
Maria Casado
CONTACT
310-794-6913
mcasado@mednet.ucla.edu

Principal Investigator

Stephanie M Yoon, MD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

University of California at Los Angeles / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: Jonsson Comprehensive Cancer Center

  • Stephanie M Yoon, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-20
Study Completion Date2026-07-01

Study Record Updates

Study Start Date2021-08-20
Study Completion Date2026-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Prostate Adenocarcinoma
  • Stage IIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8
  • Stage IIC Prostate Cancer AJCC v8
  • Stage III Prostate Cancer AJCC v8
  • Stage IIIA Prostate Cancer AJCC v8
  • Stage IIIB Prostate Cancer AJCC v8
  • Stage IIIC Prostate Cancer AJCC v8
  • Stage IVA Prostate Cancer AJCC v8