Highlights of the NCCN Oncology Research Program

The NCCN Oncology Research Program (ORP) strives to improve the quality of life for patients and reduce cancer-related deaths by advancing cancer therapies through research. Since the program's establishment in 1999, the NCCN ORP has brought millions of dollars in research grants to investigators at NCCN Member Institutions. Research grants are provided to NCCN through collaborations with pharmaceutical and biotechnology companies; these grants are in turn used to support scientifically meritorious cancer research efforts.

NCCN ORP studies typically explore new avenues of clinical investigation and seek answers to important cancer-related questions. All studies are approved and funded through a scientific peer-review process and are overseen by the ORP.

An NCCN study funded through the grant mechanism is highlighted below.

Phase II Trial of Definitive Radiotherapy With Leuprolide and Enzalutamide in High-Risk Prostate Cancer

Principal Investigator: Albert J. Chang, MD

Condition: Prostate cancer

Institution: University of California, San Francisco

This is a phase II study to evaluate the safety, toxicity, and feasibility of the addition of enzalutamide to leuprolide in patients with very high-risk prostate cancer or pelvic node–positive disease receiving radiotherapy. Very high-risk prostate cancer is defined as 2 or more of the following characteristics: (1) cT3a/b, (2) prostate-specific antigen (PSA) level of 20 ng/mL or greater and less than 150 ng/mL, (3) Gleason 8 to 10, and (4) 50% or more core involvement OR any patient with pelvic lymph node involvement.

Primary Objectives:

  • Determine the feasibility and safety of the combination of enzalutamide and leuprolide in patients undergoing definitive radiation therapy for very high-risk prostate cancer or with pelvic nodal involvement

  • Determine if the combination of enzalutamide and leuprolide improves the PSA complete response (as determined by PSA nadir ≤0.3) in patients undergoing radiation therapy for very high-risk prostate cancer or pelvic nodal involvement

Secondary Objectives:

  • Determine time to biochemical failure as determined by the ASTRO Phoenix definition of nadir + 2 ng/mL, local progression, regional progression, and distant metastases

  • Determine time to clinical progression-free survival

  • Assess PSA nadir and PSA and testosterone levels at 3 to 4, 6, 12, and 24 months

  • Assess changes in HbA1c, fasting glucose, fasting insulin, and fasting lipid and cholesterol levels

  • Document changes in quality of life outcomes

Contact: Albert J. Chang, MD, PhD • 415-353-7175 • albert.chang@ucsf.edu Frances Zhang • 415-353-9807 • frances.zhang@ucsf.edu

ClinicalTrials.gov Identifier: NCT02508636

The goal of the Highlights of the NCCN Oncology Research Program (ORP) is to provide readers with more information on the ORP, including studies currently accruing patients.

For more information on specific trials, including patient selection criteria, please use the contact information listed with each study.

For more information on the NCCN ORP, including a complete detailing of the clinical studies currently underway at NCCN Member Institutions, please access the NCCN ORP pages at NCCN.org/clinical_trials/clinicians.asp.

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