Combining high dose-rate brachytherapy and stereotactic body radiotherapy for prostate cancer treatment
Phase 2 Study of High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for Intermediate and High Risk Localized Prostate Adenocarcinoma (HYDRA)
This study is testing whether combining two types of radiation therapy can improve treatment outcomes for men with prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04945642 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining high dose-rate brachytherapy with stereotactic body radiotherapy in treating patients with prostate adenocarcinoma. The approach utilizes internal radiation therapy to deliver radioactive material directly into or near the tumor, alongside highly precise external radiation therapy. The primary objectives include estimating the biochemical progression-free survival at five years and assessing the rates of acute genitourinary and gastrointestinal symptoms following treatment. Secondary objectives focus on long-term patient-reported outcomes and toxicity assessments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed intermediate- to high-risk prostate adenocarcinoma and no evidence of metastatic disease.
Not a fit: Patients with neuroendocrine or small cell carcinoma of the prostate or those with prior invasive malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could improve survival rates and reduce side effects for patients with prostate adenocarcinoma.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California
- University of California at Los Angeles / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Stephanie M Yoon, MD — University of California, Los Angeles
- Study coordinator: Vince Basehart
- Email: vbasehart@mednet.ucla.edu
- Phone: 310-267-8954
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.