James Randall
· M.D.University of California, San Diego · Hematology and Medical Oncology
Active 1958–2026
About
James Randall is a Clinical Professor of Medicine at UC San Diego, with a focus on urologic cancer. He has recently joined the division and is building a clinical research program dedicated to this area. His research interests include interventions that may identify and help patients with cancer-related distress, including depression and suicidal ideation. Dr. Randall has received awards such as the American Society of Clinical Oncology (ASCO) 2011 Conquer Cancer Foundation Merit Award and the Sarah F. Davis Award from the University of Alabama School of Medicine in 2005, recognizing him as the best all-around male medical student. His educational background includes an MD from the University of Alabama School of Medicine, completed in 2005, followed by internship and residency at UC San Diego from 2005 to 2008, and a fellowship in Hematology/Oncology at UC San Diego from 2009 to 2012. His research encompasses various aspects of oncology, including germline testing in prostate cancer, circulating tumor DNA in metastatic prostate cancer, systemic treatment of bone disease in urinary malignancies, and molecular aberrations in renal cell carcinoma. Dr. Randall has contributed to numerous publications in these fields and is actively involved in clinical and translational research related to urologic cancers.
Research topics
- Oncology
- Medicine
- Internal medicine
- Urology
- Surgery
Selected publications
Cancer Research · 2026-04-17
articleAbstract Background: Advanced metastatic castration-resistant prostate cancer (mCRPC) remains a lethal disease with limited treatment options. Cabozantinib is a multi-tyrosine kinase inhibitor targeting VEGFR, MET, and AXL that has demonstrated activity in mCRPC patients, particularly those with bone and liver metastases. Based on our preclinical studies showing cabozantinib-mediated activation of innate immunity in PC, we investigated the efficacy of cabozantinib plus nivolumab in mCRPC patients (NCT05502315). Methods: This prospective, multi-center, single-arm, two-stage open-label phase II study enrolled patients with progressive mCRPC per PCWG3 criteria and prior androgen receptor pathway inhibitor exposure. Prior taxane was permitted. Patients received cabozantinib 40 mg daily orally plus nivolumab 480 mg IV every 4 weeks. The primary endpoint was radiographic progression-free survival (rPFS) at 6 months by RECIST 1.1/PCWG3. A Simon two-stage MiniMax design was used with 80% power, hypothesizing 6-month rPFS >30%. Stage 1 required ≥7 of 24 patients to be progression-free at 6 months to continue to Stage 2, which will enroll an additional 23 patients. Results: Twenty-four patients were enrolled in Stage 1 (median age 71 years). Baseline characteristics: 50% (12/24) had de novo metastatic disease, 91.7% (n=22) had bone metastases, 29.2% (n=7) bone-only disease, 16.7% (n=4) visceral metastases, 66.7% (n=16) received prior chemotherapy, and 25% (n=6) prior ¹⁷⁷Lu-PSMA-617 therapy. Eight patients remained progression-free at 6 months, meeting continuation criteria for Stage 2. Median rPFS was 5.5 months (95% CI >3.6 months). Objective response rate was 17.6% (3/17 evaluable patients). Median baseline PSA was 28.05 ng/mL and median time to PSA progression was 1.87 (95% CI 1.81-3.78) months. One patient experienced PSA50. Grade ≥3 treatment-related adverse events occurred in 52% (n=12) of patients, with 5 treatment-related serious adverse events. Most common adverse events were anorexia 58% (n=14), diarrhea 58% (n=14), fatigue 54% (n=13), nausea 46% (n=11), anemia 38% (n=9), AST increase 38% (n=9), ALT increase 33% (n=8), constipation 33% (n=8), and hypothyroidism 29% (n=7). Conclusions: The CANOPY trial met its interim efficacy threshold, demonstrating activity of cabozantinib plus nivolumab in mCRPC patients. The combination showed manageable toxicity. The study continues to Stage 2 enrollment to further evaluate this promising combination therapy. Citation Format: Justine Panian, Lin Liu, Minya Pu, Emily Pittman, Samuel Pena, Archana Ajmera, Yu-Wei Chen, Christos Kyriakopoulos, Qian Qin, James Michael Randall, Tian Zhang, Joshua Michael Lang, Akash Patnaik, Rana R. McKay. A phase 2 study of cabozantinib and nivolumab in metastatic castration resistant prostate cancer (CANOPY): Interim analysis [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2026; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2026 Apr 17-22; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2026;86(8_Suppl):Abstract nr CT149.
Journal of Clinical Oncology · 2026-03-01
article187 Background: Advanced metastatic castration-resistant prostate cancer (mCRPC) remains a largely lethal disease with limited treatment options. Cabozantinib is a tyrosine kinase inhibitor targeting VEGFR, MET, and AXL that has demonstrated activity in mCRPC patients, particularly those with bone and liver metastases. The CONTACT-02 trial showed efficacy of cabozantinib combined with the PD-L1 inhibitor atezolizumab in mCRPC. Building upon this background, we investigated the efficacy of cabozantinib plus nivolumab, a PD-1 inhibitor, in patients with mCRPC (NCT05502315). Methods: This prospective, multi-center, single-arm, two-stage open-label phase II study enrolled patients with progressive mCRPC per PCWG3 criteria and prior androgen receptor pathway inhibitor exposure. Prior taxane was permitted. Patients received cabozantinib 40 mg daily orally plus nivolumab 480 mg IV every 4 weeks. The primary endpoint was radiographic progression-free survival (rPFS) at 6 months by RECIST 1.1/PCWG3. A Simon two-stage MiniMax design was used with 80% power, hypothesizing 6-month rPFS >30%. Stage 1 required ≥7 of 24 patients to be progression-free at 6 months to continue to Stage 2, which will enroll an additional 23 patients. Results: Twenty-four patients were enrolled in Stage 1 (median age 71 years). Baseline characteristics: 50% (12/24) had de novo metastatic disease, 91.7% (n=22) had bone metastases, 29.2% (n=7) bone-only disease, 16.7% (n=4) visceral metastases, 66.7% (n=16) received prior chemotherapy, and 25% (n=6) prior ¹⁷⁷Lu-PSMA-617 therapy. Eight patients remained progression-free at 6 months, meeting continuation criteria for Stage 2. Median rPFS was 5.5 months (95% CI >3.6 months). Objective response rate was 17.6% (3/17 evaluable patients). Median baseline PSA was 28.05 ng/mL and median time to PSA progression was 1.87 (95% CI 1.81-3.78) months. One patient experienced PSA 50 . Grade ≥3 treatment-related adverse events occurred in 52% (n=12) of patients, with 5 treatment-related serious adverse events. Most common adverse events were anorexia 58% (n=14), diarrhea 58% (n=14), fatigue 54% (n=13), nausea 46% (n=11), anemia 38% (n=9), AST increase 38% (n=9), ALT increase 33% (n=8), constipation 33% (n=8), and hypothyroidism 29% (n=7). Conclusions: The CANOPY trial met its interim efficacy threshold, demonstrating activity of cabozantinib plus nivolumab in mCRPC patients. The combination showed manageable toxicity. The study continues to Stage 2 enrollment to further evaluate this promising combination therapy. Clinical trial information: NCT05502315 .
Cancer Epidemiology Biomarkers & Prevention · 2025-09-18
articleAbstract BACKGROUND: Hispanic/Latino (H/L) patients with prostate cancer (PCa) are at an increased risk of developing side effects related to androgen deprivation therapy (ADT). While diet and exercise can reduce these toxicities, little is known about factors influencing their engagement in health-promoting behaviors. METHODS: We developed a survey to examine sociodemographic characteristics, exercise/dietary habits, motivation for change, and barriers to participate in lifestyle interventions. We surveyed patients with PCa who self-identified as H/L ethnicity, treated at UCSD, and who were either previously or currently on ADT at the time of the survey. Questionnaires were administered in Spanish or English, either in person or by telephone, using interpreter services based on patient preference. RESULTS: Sixty one patients (median age 66 years) completed the survey with an 88% response rate. Most patients were of Mexican descent (85%), born outside the U.S. (72%), had public health insurance (51%), resided in disadvantaged neighborhoods (54%) based on the Area Deprivation Index (ADI), from H/L ethnic enclaves (64%), and were primarily Spanish speakers (51%), with 36% reporting limited English proficiency. About half (49%) reported household financial distress, yet 92% felt supported by their community or family during PCa diagnosis. At the time of the survey, 85% of patients were on ADT and 68% had distant metastasis. Most had a BMI >= 30 kg/m2 (52%), diabetes (51%), and 66% had a history of coronary artery disease (CAD) or a high-risk atherosclerotic cardiovascular disease (ASCVD) score of >= 20%. Most patients (51%) reported limited dietary monitoring and 71% reported less than 50 min/week of moderate-intensity exercise, with 41% not engaging in any moderate exercise. However, most (82%) showed interest in joining a community exercise program. Participation incentives included family involvement (73%), other H/L participants (77%), Spanish-speaking staff (86%), and a shorter driving distance. Neighborhood disadvantage (ADI quintile > 3) was linked to higher odds of CAD or high ASCVD risk (OR 5.4, p = 0.02), de novo metastatic PCa (OR >10, p < 0.01), lower clinical trial participation (OR 0.08, p < 0.01), self-reported physical inactivity (OR 4.6, p = 0.01), financial distress (OR 5, p < 0.01), and time toxicity (OR 4.6, p < 0.01). CONCLUSIONS: We report that H/L patients with PCa on ADT face substantial cardiometabolic risk factor burden and limited access to health-promoting activities due to socioeconomic and cultural barriers. Despite low physical activity, patients expressed motivation to improve health behaviors, when provided with incentives, underscoring the need for tailored interventions to mitigate ADT toxicity. These findings will inform the design of an interventional study that examines the impact of a combined group exercise and nutrition counseling intervention on physical fitness and cardiovascular health among H/L men with PCa on ADT. Citation Format: Sharon H. Choi, Frances Ramos, Bryanna Chavez, Kristine Ly, Samuel Pena, Yu-Wei Chen, J. Michael Randall, Tyler Stewart, Fred Millard, James Murphy, Noe Crespo, Soo Park, Brent Rose, Aditya Bagrodia, Elena Martinez, Rana R. McKay. Multilevel determinants of health behavior participation among Hispanic/Latino men with prostate cancer on androgen deprivation therapy: A cross-sectional survey [abstract]. In: Proceedings of the 18th AACR Conference on the Science of Cancer Health Disparities; 2025 Sep 18-21; Baltimore, MD. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2025;34(9 Suppl):Abstract nr A067.
Journal of Clinical Oncology · 2025-02-10
article321 Background: H/L pts with PCa are at an increased risk of developing ADT-related side effects. Diet and exercise can improve PCa-related outcomes, including reducing ADT-related toxicities. However, little is known about individual perspectives on factors impacting engagement in health-promoting behaviors among H/L men with PCa. Methods: We developed a survey to examine sociodemographic characteristics, exercise/dietary habits, motivation for change, and barriers to participate in lifestyle interventions. We surveyed pts with PCa who self-identified as H/L ethnicity, treated at UCSD, and who were either previously or currently on ADT at the time of the survey. Questionnaires were administered in Spanish or English, either in person or by telephone, using interpreter services based on pt preference. Results: Between April and August 2024, 61 pts (median age 66 years) completed the survey with an 88% response rate. Most pts were of Mexican descent (85%), born outside the U.S. (72%), had public health insurance (51%), resided in disadvantaged neighborhoods (54%) based on the Area Deprivation Index, from H/L ethnic enclaves (64%), and were primarily Spanish speakers (51%), with 36% reporting no English proficiency. About half (49%) reported household financial distress, yet 92% felt supported by their community or family during PCa diagnosis. At the time of the survey, 85% of pts were on ADT, 68% had distant metastasis, and 69% had undergone local therapy. Most had a BMI ≥ 30 kg/m2 (52%), diabetes (51%), and 66% had a history of coronary artery disease or a high-risk atherosclerotic cardiovascular disease score of ≥ 20%. Most pts (51%) reported limited dietary monitoring and 71% reported less than 50 min/week of moderate-intensity exercise, with 41% not engaging in any moderate exercise. However, most expressed motivation to initiate lifestyle changes (91% exercise; 83% diet) and 82% showed interest in joining a community lifestyle intervention program. Pts identified participation incentives including family involvement (73%), other H/L participants (77%), Spanish-speaking staff (86% among Spanish speakers), and a driving distance of less than 5 miles. Conclusions: We report that H/L pts with PCa on ADT have substantial cardiometabolic risk factors. While engagement in health-promoting activities was limited, patients expressed motivation to improve health-promoting practices, with actionable incentives to enhance participation, underscoring the need for tailored intervention to mitigate ADT toxicity in this pt population. These findings will inform the design of an interventional study that examines the impact of a combined group exercise and nutrition counseling intervention on physical fitness and cardiovascular health among H/L men with PCa on ADT.
CLO25-100: Improving Germline Testing in At-Risk Patients With Prostate Cancer
Journal of the National Comprehensive Cancer Network · 2025-03-28
articleIMPROVING GERMLINE TESTING IN AT-RISK PATIENTS WITH PROSTATE CANCER
Urologic Oncology Seminars and Original Investigations · 2025-02-27
articleEuropean Psychiatry · 2025-04-01
articleOpen accessIntroduction The risk of self-harm is highest in younger age groups, with increasing numbers of under-18s being admitted to hospital due to self-harm in recent years in the UK1,2. The National Institute for Health and Care Excellence (NICE) guidelines for self-harm in adolescents over eight was updated in September 2022 and reinforces the need for the proper initial management of adolescent self-harm3. To our knowledge, our study is the first UK national audit on the management of self-harm in adolescents presenting to the emergency department using the updated NICE guidelines. Objectives To assess the clinical management of children and adolescents who present to the Emergency Department (ED) following self-harm, a cross-sectional, multicentre study was conducted within teaching hospitals affiliated with nine medical schools across England, Wales and Scotland. Methods Data was retrospectively collected from ED records using consecutive sampling of individuals aged 8 to 17 years who presented with self-harm from 7 Sep-7 Nov 2022. Results Records from 328 patients were included in the final analysis. Most patients were female (82.0%) and white (68.2%), with a mean age of presentation of 14.7 (σ = 1.58). The rate of positive responses to each question is available in Table 1. A ‘positive’ response is defined as a ‘yes’ response, rather than ‘no’ or ‘not documented’. Table 1. Rate of compliance with audit criteria Study Intervention Sample Size Outcome Measure Key Findings Lamy et al. (2020) SGAs (multiple RCTs) >50 trials ABC, CGI Significant reduction in irritability (p<0.05) Ghanizadeh et al. (2014) Aripiprazole, Risperidone 59 ABC Reduction in symptoms; fewer adverse events with aripiprazole King et al. (2009) Citalopram, Placebo 149 CGI, CY-BOCS No significant benefit over placebo; more adverse effects Conclusions This is the first study, to our knowledge, that investigates the management of self-harm in under 18s across the UK using the updated NICE guidelines. Some criteria may have been adhered to but not documented. The results from this study provide support for the further improvement of clinical practice in the management of self-harming children and adolescents. Disclosure of Interest None Declared
A valuable glioblastoma prognostic marker driven by radiosensitivity
Neuro-Oncology · 2024-01-23
letterOpen access1st authorJournal Article A valuable glioblastoma prognostic marker driven by radiosensitivity Get access James Randall, James Randall Department of Radiation Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, USA Search for other works by this author on: Oxford Academic PubMed Google Scholar Sean Sachdev Sean Sachdev Department of Radiation Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, USA Corresponding Author: Sean Sachdev, MD, Department of Radiation Oncology, Northwestern University Robert H. Lurie Comprehensive Cancer Center, 676 N St. Clair, Arkes Pavilion, Suite 1820, Chicago, IL 60611, USA (sean.sachdev@northwestern.edu). https://orcid.org/0000-0001-7682-9673 Search for other works by this author on: Oxford Academic PubMed Google Scholar Neuro-Oncology, Volume 26, Issue 3, March 2024, Pages 514–515, https://doi.org/10.1093/neuonc/noad266 Published: 23 January 2024 Article history Published: 23 January 2024 Corrected and typeset: 30 January 2024
Journal of Clinical Oncology · 2024 · 45 citations
- Medicine
- Urology
- Internal medicine
PURPOSE: Patients with biochemically recurrent prostate cancer (BRPC) after radical prostatectomy and a short PSA doubling time are at risk for distant metastases. Apalutamide, an androgen receptor antagonist, and abiraterone acetate plus prednisone (AAP) prolong survival in the metastatic setting. We evaluated whether intensification of androgen-deprivation therapy (ADT) improves outcomes in BRPC. PATIENTS AND METHODS: PRESTO is a randomized phase III, open-label trial in patients with BRPC and PSA doubling time ≤9 months (ClinicalTrials.gov identifier: NCT03009981). Patients were randomly assigned 1:1:1 to receive a finite 52-week treatment course with ADT control, ADT + apalutamide, or ADT + apalutamide + AAP. The primary end point was PSA progression-free survival (PSA-PFS), defined as serum PSA >0.2 ng/mL after treatment completion. RESULTS: = .00008). Median time to testosterone recovery did not differ across treatment arms. The most common grade ≥3 adverse event was hypertension (7.5%, 7.4%, and 18% in ADT, ADT + apalutamide, and ADT + apalutamide + AAP arms, respectively). CONCLUSION: Intensified AR blockade for a finite duration prolongs PSA-PFS with a manageable safety profile, without adversely affecting time to testosterone recovery. The addition of apalutamide to ADT should be considered in patients with high-risk BRPC.
2023-03-31
preprintOpen access<p>S. Figure 2 Landmark PFS Total Alterations</p>
Frequent coauthors
- 19 shared
Razelle Kurzrock
Medical College of Wisconsin Cancer Center
- 13 shared
Lyudmila Bazhenova
University of California, San Diego
- 13 shared
Frederick Millard
- 12 shared
Rana R. McKay
- 11 shared
Yulian Khagi
University of California, Irvine
- 11 shared
Assuntina G. Sacco
University of California, San Diego
- 11 shared
Sandip Pravin Patel
University of California, San Diego
- 11 shared
Gregory A. Daniels
University of California, San Diego
Labs
James Randall LabPI
Education
- 1990
Ph.D., Medicine
University of California, San Diego
- 1986
M.D.
University of California, San Diego
- 1982
B.S., Biology
University of California, San Diego
Awards & honors
- American Society of Clinical Oncology (ASCO) 2011 Conquer Ca…
- University of Alabama School of Medicine 2005 Sarah F. Davis…
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