Germline DNA-Based Radiosensitivity Biomarker Influence on Toxicity Following Prostate Radiothera… (NCT04624256) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Germline DNA-Based Radiosensitivity Biomarker Influence on Toxicity Following Prostate Radiotherapy, GARUDA Trial
United States208 participantsStarted 2020-11-10
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Patients with neuroendocrine or small cell carcinoma of the prostate
* Patients with any evidence of distant metastases. Note, evidence of lymphadenopa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
2-year cumulative incidence of late grade >= 2 physician-scored genitourinary toxicity