NCT04624256Active, not recruiting
Germline DNA-Based Radiosensitivity Biomarker Influence on Toxicity Following Prostate Radiotherapy, GARUDA Trial
Germline DNA-Based Radiosensitivity Biomarker Influence on Toxicity Following Prostate Radiotherapy
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
This trial studies the changes in long-term physician-scored genitourinary toxicity achieved in prostate cancer patients eligible for stereotactic radiation therapy when both patients and physicians have access to convincing but non-validated germline signature that can characterize patients as having a low or high risk of developing toxicity after radiation therapy. The information learned from this study may guide patients' and physicians' decisions on radiotherapy fractionation.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 208 (actual)
- First submitted
- 26 Oct 2020
- Start date
- 10 Nov 2020
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Diseases
- Prostate cancer
- NCT number
- NCT04624256
What you commit to
- Study type: Interventional
- Participants enrolled: 208
- From 10 Nov 2020 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior whole-gland cryosurgery, high-intensity focused ultrasound (HIFU) or brachytherapy of the prostate
- Prior pelvic radiotherapy
Other illness
- History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
Other
- Patients with neuroendocrine or small cell carcinoma of the prostate
- Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator
Who the study is looking for
- Histologically confirmed, clinical localized adenocarcinoma of the prostate
- 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)
- Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) on the basis of risk grouping:
- Low risk: No staging workup required
- Favorable intermediate-risk: computed tomography (CT) abdomen/pelvis only if Memorial Sloan Kettering Cancer Center (MSKCC) nomogram predicts \> 10% probability of lymph node involvement (note: CT simulation scan will count as a CT abdomen/pelvis)
- Unfavorable intermediate-risk: technetium bone scan, CT abdomen/pelvis if MSKCC nomogram predicts \> 10% probability of lymph node involvement (note: CT simulation scan will count as a CT abdomen/pelvis)
- High-risk: technetium bone scan, CT abdomen/pelvis if MSKCC nomogram predicts \> 10% probability of lymph node involvement (note: CT simulation scan will count as a CT abdomen/pelvis) =
- Advanced imaging studies (i.e. prostate specific membrane antigen \[PSMA\] positron emission tomography \[PET\] and Axumin scan) can supplant a bone scan if performed first
- Ability to understand, and willingness to sign, the written informed consent
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.