Germline DNA-Based Radiosensitivity Biomarker Influence on Toxicity Following Prostate Radiotherapy, GARUDA Trial

Not Applicable

Active, not recruiting

• Conditions: Prostate Adenocarcinoma; Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8; Stage II Prostate Cancer AJCC v8; Stage IIA Prostate Cancer AJCC v8; Stage IIB Prostate Cancer AJCC v8; Stage IIC Prostate Cancer AJCC v8

• Registration Number: NCT04624256
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-26
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Male
• Target Recruitment: 226

Inclusion Criteria

Inclusion Criteria:<br><br> - Histologically confirmed, clinical localized adenocarcinoma of the prostate<br><br> - No evidence of disease beyond the prostate and/or seminal vesicles (i.e., no<br> suspicious pelvic lymph nodes or presence of metastatic disease outside the pelvis)<br><br> - Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) on<br> the basis of risk grouping:<br><br> - Low risk: No staging workup required<br><br> - Favorable intermediate-risk: computed tomography (CT) abdomen/pelvis only if<br> Memorial Sloan Kettering Cancer Center (MSKCC) nomogram predicts > 10%<br> probability of lymph node involvement (note: CT simulation scan will count as a<br> CT abdomen/pelvis)<br><br> - Unfavorable intermediate-risk: technetium bone scan, CT abdomen/pelvis if MSKCC<br> nomogram predicts > 10% probability of lymph node involvement (note: CT<br> simulation scan will count as a CT abdomen/pelvis)<br><br> - High-risk: technetium bone scan, CT abdomen/pelvis if MSKCC nomogram predicts ><br> 10% probability of lymph node involvement (note: CT simulation scan will count<br> as a CT abdomen/pelvis) =<br><br> - Advanced imaging studies (i.e. prostate specific membrane antigen [PSMA]<br> positron emission tomography [PET] and Axumin scan) can supplant a bone scan if<br> performed first<br><br> - Ability to understand, and willingness to sign, the written informed consent<br><br>Exclusion Criteria:<br><br> - Patients with neuroendocrine or small cell carcinoma of the prostate<br><br> - Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy<br> below the level of the renal arteries can be deemed loco regional per the discretion<br> of the investigator<br><br> - Prior whole-gland cryosurgery, high-intensity focused ultrasound (HIFU) or<br> brachytherapy of the prostate<br><br> - Prior pelvic radiotherapy<br><br> - History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
5-year cumulative incidence of late grade >= 2 physician-scored genitourinary toxicity

Secondary Outcome Measures

Name	Time	Method
5-year biochemical recurrence-free survival;Rate of acute grade >= 2 genitourinary and gastrointestinal physician-scored toxicity;Rate of acute grade >= 2 gastrointestinal physician-scored toxicity;5-year cumulative incidence of Late grade >= 2 GU physician-scored toxicity;Proportions of patients who choose to receive radiation treatment;Change in patient-reported urinary quality of life;Change in patient-reported bowel quality of life;Change in patient-reported sexual quality of life outcome;Change in patient-reported sexual quality of life by the Sexual Health Inventory for Men instrument by five years