NCT04945642 High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma
| NCT ID | NCT04945642 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jonsson Comprehensive Cancer Center |
| Condition | Prostate Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2021-08-20 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 52 participants in total. It began in 2021-08-20 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Stephanie M Yoon, MD
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT04945642 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04945642 currently recruiting?
Yes, NCT04945642 is actively recruiting participants. Contact the research team at vbasehart@mednet.ucla.edu for enrollment information.
Where is the NCT04945642 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT04945642 clinical trial?
NCT04945642 is sponsored by Jonsson Comprehensive Cancer Center. The principal investigator is Stephanie M Yoon, MD at University of California, Los Angeles. The trial plans to enroll 52 participants.