A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of MITOGEL™ (mitomycin) urothelial gel, 0.4% on Ablation of Upper Urinary Tract Urothelial Carcinoma (NCT02793128)

The OLYMPUS trial is a phase III multicenter trial designed to assess the efficacy and safety of treatment with MITOGEL™ (mitomycin) urothelial gel, 0.4% , in the upper urinary system of patients with non-invasive low-grade, urinary tract urothelial carcinoma (UTUC). MITOGEL™ is a gel formulation of mitomycin for ureteral instillation which is designed to maintain the drug over a prolonged period in the upper urinary system in order to treat low –grade UTUC.

In this study, all eligible patients will receive MITOGEL™ instillations  into upper urinary tract once per week for 6 weeks. The administration of MITOGEL™ will be performed through a standard ureteral catheter.  If the tumor(s) disappear after 6 instillations, patients will receive up to an additional 11 (eleven) maintenance treatments.

The OLYMPUS trial is based on safety and efficacy results from a Compassionate Use Program in patients with severe, non-resectable, low-grade UTUC, demonstrating complete response (no visible disease confirmed by negative cytology) in over 60% of the evaluated patients that completed treatment, showing the potential chemoablative effects of MITOGEL™. In addition, these patients demonstrated lower recurrence episodes following MITOGEL™ treatment.


Inclusion criteria (partial list):

  • Patients with upper tract urothelial carcinoma (UTUC)
  • Patients with  low grade tumor

Exclusion criteria (partial list):

  • Patient received BCG treatment during the 6 months prior to the study
  • Patient has carcinoma in situ in the past in the urinary tract.
  • Patient has a history of invasive urothelial carcinoma in the urinary tract during the past 5 (Five) years.
  • Patient has an history of high grade papillary urothelial carcinoma in the urinary tract during the past 2 (Two) years.
  • Patient is being treated with systemic chemotherapy

Medical centers in USA and Israel have opened the OLYMPUS study for patient enrollment.


Alaska Urological Institute
Anchorage, Alaska, United States, 99503
Contact: Josh Logan, MD

Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Contact: Mitchell Humphreys, M.D.

University of California
Davis, California, United States, 95616
Contact: Marc Dall’Era, MD

Loma Linda Cancer Center
Loma Linda, California, United States, 92354
Contact: Brian Hu, M.D.
Contact: Arielle Dennis

University of California
Los Angeles, California, United States, 90095
Contact: Karim Chamie, MD

Providence Medical Institute
Santa Monica, California, United States, 90404
Contact: Jennifer Linehan, M.D.
Contact: Dorreth King-Rucker

Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Contact: Raymond Pak, M.D.

Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Contact: Hristos Kaimakliotis, M.D.
Contact: Courtney Dhondt

University of Iowa
Iowa City, Iowa, United States, 52242
Contact: Mike O’Donnell, M.D.
Contact: Janelle Born

John Hopkins University
Baltimore, Maryland, United States, 21218
Contact: Phillip Pierorazio, MD

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Contact: Alon Weizer, M.D.

University of Minnesota
Minneapolis, Minnesota, United States, 55455
Contact: Christopher Weight, M.D.

Mayo Clinic health system
Rochester, Minnesota, United States, 55905
Contact: Lance Mynderse, M.D.

Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center
New York, New York, United States, 10032-3784
Contact: Ojas Shah, M.D.
Contact: Anna Rodriguez

Weill Cornell Medical Center
New York, New York, United States, 10065
Contact: Douglas S Scherr, MD

Montefiore Medical Center (Albert Einstein)
The Bronx, New York, United States, 10467
Contact: Joshua Stern, MD

University of north carolina – Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Contact: Michael Woods, MD

Duke University
Durham, North Carolina, United States, 27708
Contact: Brant Inman, M.D.

Cleveland Clinic
Cleveland, Ohio, United States, 44195
Contact: Andrew Stephenson, M.D.

The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Contact: Ahmad Shabsigh, MD

Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033
Contact: Jay Raman, M.D.

Thomas Jefferson University Hospitals
Philadelphia, Pennsylvania, United States, 19107
Contact: Scott Hubosky, M.D.

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jefferey Gingrich, MD

MD Anderson
Houston, Texas, United States, 77006
Contact: Surena Matin, MD

Baylor College of Medicine
Houston, Texas, United States, 77030
Contact: Guilherme Godoy, MD

Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Contact: Michael Williams, M.D.

Sheba Medical Center, Israel
Ramat Gan, Israel, 52621
Contact: Nir Kleinmann, M.D.

For further information please visit:

CLinicaltrials.gov site 

Center Watch

 Bladder cancer advocacy group -BCan

For physicians interested in participating, please contact Dr Ifat Klein ifatk@urogen.com