Current Clinical Trials in Prostate Cancer

Clinically reviewed by Mehmet Sitki Copur, MD, FACP

Prostate cancer is the most frequent cancer found in American men, and the second leading cause of cancer death in this population. In 2019 an estimated 174,650 new cases of prostate cancer were diagnosed in the United States, with 31,620 resultant deaths[1]. The incidence of this cancer rises with age. On autopsy about 30% of men aged 60–69 years vs. 67% of men aged 80–89 years are diagnosed with prostate cancer. Risk factors include family history, African American race, and high fat intake.

The majority of prostate cancers are adenocarcinomas, and signs or symptoms can include: focal nodules or induration within the prostate on digital rectal exam, lymph node metastases, lower extremity edema, back pain secondary to pathologic fractures, and urinary obstruction. Prostate cancer can often be found before symptoms start by testing the amount of prostate-specific antigen (PSA) in a man’s blood. To help with diagnosis, clinicians perform digital rectal exam, tests for increase prostate specific antigen (PSA) levels, transrectal ultrasound, MRI of the prostate, and more.

For men with newly diagnosed prostate cancer risk stratification in selecting the initial treatment is crucial and include, anatomic extent of disease (tumor, node, metastasis [TNM] stage), histologic grade (Gleason score/grade group) and molecular characteristics of the tumor, serum PSA level, estimated outcome with different treatment options, potential complications with each treatment approach, and the patient’s general medical condition, age, and comorbidity, as well as individual preferences. Treatment options include active surveillance, surgical and radiation therapy hormonal treatment with androgen deprivation at the pituitary/hypothalamus, prostate cells, testes and adrenal gland levels, chemotherapy, immunotherapy Active surveillance avoids treatment in men who never experience disease progression, while monitoring and treating men with disease progression.[2]

Currently, scores of reputable clinical trials are underway and recruiting patients.

A Multi-modal, Physician-centered Intervention to Improve Guideline-concordant Prostate Cancer Imaging.
ClinicalTrials.gov Identifier: NCT03445559.
VA Office of Research and Development, 11 U.S. locations.

Outcomes of Focal Therapies for Prostate Cancer.
ClinicalTrials.gov Identifier: NCT03492424.
Weill Cornell Medicine, New York, New York.

Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy.
ClinicalTrials.gov Identifier: NCT01834001.
National Institutes of Health Clinical Center, Bethesda, Maryland.

PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer.
ClinicalTrials.gov Identifier: NCT03232164.
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.

Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer.
ClinicalTrials.gov Identifier: NCT03889119.
Hoag Memorial Hospital Presbyterian, Irvine, California.

Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy.
ClinicalTrials.gov Identifier: NCT01834001.
National Institutes of Health Clinical Center, Bethesda, Maryland.

PD-L1 Inhibition as Checkpoint Immunotherapy for Neuroendocrine Phenotype Prostate Cancer (PICK-NEPC).
ClinicalTrials.gov Identifier: NCT03179410.
Duke University Medical Center, Durham, North Carolina.

A Study of Olaparib and Durvalumab in Prostate Cancer.
ClinicalTrials.gov Identifier: NCT03810105.
Memorial Sloan-Kettering Cancer Center, New York, New York, 5 U.S. locations.

Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy.
ClinicalTrials.gov Identifier: NCT03253744.
National Institutes of Health Clinical Center, Bethesda, Maryland.

Nivolumab in Patients With High-Risk Biochemically Recurrent Prostate Cancer.
ClinicalTrials.gov Identifier: NCT03637543.
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 2 U.S. locations.

Effect of Androgen Deprivation Therapy on Cardiovascular Function in Prostate Cancer.
ClinicalTrials.gov Identifier: NCT03275181.
Kansas State University - Clinical Integrative Physiology Laboratory, Manhattan, Kansas.

Trial of Curcumin to Prevent Progression of Low-risk Prostate Cancer Under Active Surveillance.
ClinicalTrials.gov Identifier: NCT03769766.
UT Southwestern Medical Center, Dallas, Texas.

BrUOG 337: Olaparib Prior to Radical Prostatectomy For Patients With Locally Advanced Prostate Cancer and Defects in DNA Repair Genes (337).
ClinicalTrials.gov Identifier: NCT03432897.
Lifespan Cancer Institute: The Miriam and Rhode Island Hospitals, Providence, Rhode Island.

Focal Laser Ablation of Prostate Cancer Tumors.
ClinicalTrials.gov Identifier: NCT02600156.
Mayo Clinic in Minnesota, Rochester, Minnesota.

Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer.
ClinicalTrials.gov Identifier: NCT03565835.
Montefiore Medical Center, Bronx, New York.

Prostate Cancer Intensive, Non-Cross Reactive Therapy (PRINT) for Castration Resistant Prostate Cancer (CRPC).
ClinicalTrials.gov Identifier: NCT02903160.
Mount Sinai Beth Israel, New York, New York, 3 U.S. locations.

REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer.
ClinicalTrials.gov Identifier: NCT03951831.
Columbia University Irving Medical Center, New York, New York.

Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer.
ClinicalTrials.gov Identifier: NCT03646162.
Gen1 Research, Glendale, Arizona, 20 locations in the U.S.

PreOperative RadioTherapy for High-Risk Prostate Cancer (PORT-PC Trial) (PORT-PC).
ClinicalTrials.gov Identifier: NCT03663218.
Weill Cornell Medicine, New York, New York.

Abiraterone Acetate, Niclosamide, and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer.
ClinicalTrials.gov Identifier: NCT02807805.
University of California Davis Comprehensive Cancer Center, Sacramento, California.

CART-PSMA-TGFβRDN Cells for Castrate-Resistant Prostate Cancer.
ClinicalTrials.gov Identifier: NCT03089203.
University of Pennsylvania, Philadelphia, Pennsylvania.

Focal Radiation for Oligometastatic Castration-resistant Prostate Cancer (FORCE).
ClinicalTrials.gov Identifier: NCT03556904.
University of Michigan Cancer Center, Ann Arbor, Michigan.

ESK981 in Treating Patients With Metastatic Castrate-Resistant Prostate Cancer.
ClinicalTrials.gov Identifier: NCT03456804.
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, 2 U.S. locations.

LEE011 (Ribociclib) in Combination With Docetaxel Plus Prednisone in mCRPC.
ClinicalTrials.gov Identifier: NCT02494921.
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, with 3 U.S. locations.

Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes.
ClinicalTrials.gov Identifier: NCT03762759.
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, with 2 U.S. locations.

Disclosures:

Dr. Saleh and Dr. Copur have no significant financial interest in or other relationship with the manufacturer of any product or provider of any service mentioned in this article.

References:

1. Prostate Cancer. In: Papadakis MA, McPhee SJ, Bernstein J. eds. Quick Medical Diagnosis & Treatment 2019 New York, NY: McGraw-Hill; . http://accessmedicine.mhmedical.com.proxygw.wrlc.org/content.aspx?bookid=2566&sectionid=206893258. Accessed July 24, 2019.