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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California at Los Angeles / Jonsson Comprehensive Cancer Center
RECRUITING
Los Angeles
Contact Information
Primary
Vince Basehart
vbasehart@mednet.ucla.edu
310-267-8954
Backup
Maria Casado
mcasado@mednet.ucla.edu
310-794-6913
Time Frame
Start Date: 2021-08-20
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 52
Treatments
Experimental: Treatment (HDR-BT, SBRT)
Patients undergo HDR-BT for up to 24 hours and undergo SBRT every other day or consecutive days for up to 14 consecutive chronologic days in the absence of disease progression or unacceptable toxicity.
Related Therapeutic Areas
Sponsors
Leads: Jonsson Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov