Adult Clinical Trials

Genitourinary Cancers - Prostate cancer and cancers of the kidney, bladder, and male organs

If you need additional information about any of the trials, please call the GU Oncology Adult Clinical Trials team at 919.681.1030.

14 trials identified.

Whole Blood from Healthy Volunteers for the Study of Circulating Tumor Cells
Phase: Phase II
Sponsor: PI initiated
Principal Investigator: Andrew Armstrong
Contact: GU Oncology Clinical Trials Office
Phone: 919.681.1030
Reference Number: 00027680

Evaluation of lymph node metastases in men undergoing treatment with sipuleucel-T for metastatic castrate-resistant prostate cancer
Phase: Phase I
Sponsor: Internal Investigator Initiated Therapeutic &/or Interventional
Principal Investigator: Brant Inman
Contact: GU Oncology Clinical Trials Office
Phone: 919.681.9822
Reference Number: 00047231

A Phase 1/2 Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VT-464 in Patients with Castration-Resistant Prostate Cancer
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Daniel George
Contact: GU Oncology Clinical Trials Office
Phone: 919.681.1030
Purpose: The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics and activity of VT-464, a lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer (CRPC).
Reference Number: 00048629
View this trial at ClinicalTrials.gov

Molecular mechanisms underlying prostate cancer disparities.
Phase: N/A
Sponsor: Internal Investigator Initiated Non-therapeutic/Non-interventional
Principal Investigator: Steven Patierno
Contact: GU Oncology Clinical Trials Office
Phone: 919.681.1030
Reference Number: 00053535

EXTEND: Safety and Efficacy of EXercise Training in Men Receiving ENzalutamide in Combination with Conventional Androgen Deprivation Therapy for Hormone Nave Prostate Cancer
Phase: Phase II
Sponsor: Internal Investigator Initiated Therapeutic &/or Interventional
Principal Investigator: Michael Harrison
Contact: GU Oncology Clinical Trials Office
Phone: 919.681.1030
Purpose: This study will examine the effect of supervised exercise training on cardiopulmonary function in men receiving the combination of enzalutamide (ENZ) and androgen deprivation therapy (ADT) for treatment of non-metastatic, hormone-naïve prostate cancer. No study to date has examined the efficacy, tolerability, and safety of exercise training to prevent and/or mitigate common adverse toxicities in men receiving combination androgen suppression therapy for hormone-naïve prostate cancer.
Reference Number: 00053924
View this trial at ClinicalTrials.gov

PEAX: Men with Metastatic Castrate-Resistant Prostate Cancer Treated with Either Sipuleucel-T (Provenge), Enzalutamide (Xtandi) or Abiraterone Acetate (Zytiga) Undergoing Cardiopulmonary EXercise Testing
Phase: N/A
Sponsor: Internal Investigator Initiated Non-therapeutic/Non-interventional
Principal Investigator: Michael Harrison
Contact: GU Oncology Clinical Trials Office
Phone: 919.681.1030
Purpose: This is a pilot exercise physiology and quality of life study of subjects receiving standard of care therapy for their prostate cancer using FDA-approved drugs per their labeling (abiraterone, enzalutamide, or sipuleucel-T). Subjects with progressive, asymptomatic or minimally symptomatic mCRPC scheduled to be treated with either enzalutamide or abiraterone acetate for =3 months or a course of sipuleucel-T will be allocated to one of the treatments arms, according to the treatment chosen by the treating physician.
Reference Number: 00058229
View this trial at ClinicalTrials.gov

Defining the Relevant Immune Checkpoints Expressed on Metastatic Prostate Cancer Circulating Tumor Cells
Phase: N/A
Sponsor: Internal Investigator Initiated Non-therapeutic/Non-interventional
Principal Investigator: Andrew Armstrong
Contact: GU Oncology Clinical Trials Office
Phone: 919.681.1030
Reference Number: 00063296

A Randomized Phase 2 Study of Sipuleucel-T with or without Radium-223 in Men with Asymptomatic or Minimally Symptomatic Bone-Metastatic Castrate-Resistant Prostate Cancer
Phase: Phase II
Sponsor: External Investigator-Sponsored (External Med Ctr)
Principal Investigator: Andrew Armstrong
Contact: GU Oncology Clinical Trials Office
Phone: 919.681.1030
Purpose: This clinical trial studies the effect of radium-223 when added to sipuleucel-T for treating castrate-resistant prostate cancer that has spread to the bone. Sipuleucel-T is an autologous cellular immunotherapy designed to stimulate an immune response against prostate cancer. It has been suggested that the immune response may be strengthened by radiation therapy. Therefore this study is testing whether radium-223 added to sipuleucel-T increases the immune response and anti-tumor effect against prostate cancer.
Reference Number: 00065532
View this trial at ClinicalTrials.gov

A Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 as a Single Agent and In Combination With Enzalutamide in Subjects with Metastatic Castrate-Resistant Prostate Cancer
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Andrew Armstrong
Contact: GU Oncology Clinical Trials Office
Phone: 919.681.1030
Purpose: This study consists of two phases: Dose Escalation (Phase 1b) and Dose Expansion (Phase 2) The Dose Escalation phase will evaluate the safety and tolerability of GS-5829 as a single agent and in combination with enzalutamide, as well as determine the maximum tolerated dose (MTD) of GS-5829 as a single agent and in combination with enzalutamide in participants with metastatic castrate-resistant prostate cancer (mCRPC). The Dose Expansion phase will evaluate the following: - In group 1, the efficacy of GS-5829 as a single agent in participants with mCRPC who have progressed while receiving enzalutamide (may have also received abiraterone) - In group 2, the efficacy of GS-5829 combined with enzalutamide in participants with mCRPC who have progressed while receiving treatment with abiraterone (may not have previously received enzalutamide) - In group 3, the efficacy of GS-5829 combined with enzalutamide in participants with mCRPC who have had Prostate Specific Antigen (PSA) progression, but not radiographic progression, while receiving treatment with enzalutamide (participants may have also previously received abiraterone)
Reference Number: 00066478
View this trial at ClinicalTrials.gov

A Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Escalating Doses of a Vaccine-Based Immunotherapy Regimen (VBIR) for Prostate Cancer (Pf-06753512)
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Tian Zhang
Contact: GU Oncology Clinical Trials Office
Phone: 919.681.1030
Purpose: The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of a vaccine-based immunotherapy regimen for patients with prostate cancer.
Reference Number: 00067872
View this trial at ClinicalTrials.gov

A Phase 3 Study to Evaluate the Safety and Efficacy of 99mTc-MIP-1404 SPECT/CT Imaging to Detect Clinically Significant Prostate Cancer in Men with Biopsy Proven Low-Grade Prostate Cancer who are Candidates for Active Surveillance (proSPECT-AS)
Phase: Phase III
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Thomas Polascik
Contact: GU Oncology Clinical Trials Office
Phone: 919.681.1030
Reference Number: 00069229

A Multinational, Phase 3, Randomized, Double-blind, Placebo- controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
Phase: Phase III
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Andrew Armstrong
Contact: GU Oncology Clinical Trials Office
Phone: 919.681.1030
Purpose: The purpose of this study is to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study will also evaluate the safety of enzalutamide plus ADT in mHSPC.
Reference Number: 00073953
View this trial at ClinicalTrials.gov

A Multi-center, Open Label, Randomized Phase 2 Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Megan Diehl
Contact: GU Oncology Clinical Trials Office
Phone: 919.681.1030
Purpose: The purpose of this study is to evaluate the progression free survival (PFS), based on investigator radiologic review, of AGS-16C3F compared to axitinib in subjects with metastatic renal cell carcinoma.
Reference Number: 00074533
View this trial at ClinicalTrials.gov

Exploring relevant immune-based biomarkers and circulating tumor cells during treatment with immune checkpoint inhibitors in genitourinary malignancies
Phase: N/A
Sponsor: Internal Investigator Initiated Non-therapeutic/Non-interventional
Principal Investigator: Tian Zhang
Contact: GU Oncology Clinical Trials Office
Phone: 919.681.1030
Reference Number: 00076768