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 range18 Years
SexMALE
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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…
What they're measuring
1
2-year cumulative incidence of late grade >= 2 physician-scored genitourinary toxicity