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Trial record 1 of 1 for:    PrTK04
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Randomized Controlled Trial of ProstAtak® Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Advantagene, Inc.
Sponsor:
Information provided by (Responsible Party):
Advantagene, Inc.
ClinicalTrials.gov Identifier:
NCT02768363
First received: May 6, 2016
Last updated: May 9, 2017
Last verified: May 2017
  Purpose
The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in patients undergoing active surveillance for localized prostate cancer. ProstAtak® involves the use of aglatimagene besadenovec (AdV-tk) to kill tumor cells and stimulate a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak® has been well tolerated in previous trials in patients with prostate cancer and other tumor types. Biochemical, pathologic and immune responses have been demonstrated in newly diagnosed and recurrent prostate cancer. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak® or control arm at a 2:1 ratio. Both arms receive standard of care active surveillance evaluations.

Condition Intervention Phase
Prostate Cancer Biological: aglatimagene besadenovec Biological: placebo Drug: valacyclovir Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Advantagene, Inc.:

Primary Outcome Measures:
  • Proactive surveillance score [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Biochemical response (change in PSA) [ Time Frame: Assessed at each visit at 3, 6, 9 and 12 months ]
  • Patient reported Health Related Quality of Life [ Time Frame: Assessed at each visit at 3, 6, 9 and 12 months ]
  • Time to radical treatment [ Time Frame: 5 years ]
  • The safety profile will be characterized by collection of adverse event information and laboratory values during the treatment phase. [ Time Frame: Assessed at each visit at 3, 6, 9 and 12 months ]

Estimated Enrollment: 156
Study Start Date: May 2016
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ProstAtak®
Patients randomized to the ProstAtak arm will receive two courses of aglatimagene besadenovec + valacyclovir
Biological: aglatimagene besadenovec
Aglatimagene besadenovec will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second aglatimagene besadenovec injection will be 2-3 weeks after the first followed by 14 days of valacyclovir.
Other Name: AdV-tk
Drug: valacyclovir
Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection.
Placebo Comparator: Placebo
Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir
Biological: placebo
Placebo will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second placebo injection will be 2-3 weeks after the first followed by 14 days of valacyclovir.
Drug: valacyclovir
Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria include:

  • Histologically confirmed adenocarcinoma of the prostate
  • Patients choosing active surveillance
  • Patients meeting definition of NCCN low risk, intermediate risk OR patients having only one NCCN high-risk feature

    • NCCN Low Risk is defined as having all of the following: PSA < 10 ng/ml, Gleason ≤ 6, T1-T2a
    • NCCN Intermediate Risk is defined as having at least one of the following and no high risk features: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c
    • High Risk with a single high risk feature is defined as having only one of the following: PSA>20 ng/ml, Gleason score 8-10, or T3a
    • Excluded are those in the following risk groups: High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1
  • Patients must be planning and medically able to tolerate multiple transrectal ultrasound guided injections.
  • ECOG Performance status 0-2

Exclusion Criteria include:

  • Active liver disease, including known cirrhosis or active hepatitis
  • Patients on systemic corticosteroids (>10 mg prednisone per day) or other immunosuppressive drugs
  • Known HIV+ patients
  • Regional lymph node involvement or distant metastases
  • Other current malignancy (except squamous or basal cell skin cancers)
  • Other serious co-morbid illness or compromised organ function that, in the opinion of the investigator, would interfere with treatment or follow up
  • Prior treatment for prostate cancer except TURP. If prior TURP, patients must be deemed able to receive prostate biopsy and multiple intra-prostatic injections by the investigator
  • Patients taking 5-alpha-reductase inhibitors (e.g. finasteride, dutasteride)
  • Patients who had or plan to use ADT or have history of an orchiectomy.
  • Patients who are planning to undergo radical treatment for prostate cancer within 12 months.
  • Known sensitivity or allergic reactions to acyclovir or valacyclovir
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02768363

Locations
United States, Maryland
Walter Reed National Military Medical Center Not yet recruiting
Bethesda, Maryland, United States, 20889
Contact: Judith A Travis, BSN, RN    301-319-2927    judith.a.travis.ctr@mail.mil   
Principal Investigator: Inger L Rosner, MD, MC         
United States, Massachusetts
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Margaret R Humphries, RN, CCRC    508-856-5711    Margaret.Humphries@umassmed.edu   
Principal Investigator: Mitchell H Sokoloff, MD         
United States, New York
Advanced Radiation Centers of New York (Integrated Medical Professionals) Recruiting
Hartsdale, New York, United States, 10530
Contact: Kristen Hoffman    631-963-7700 ext 205    khoffman@imppllc.com   
Contact: Michelle Primiano    516-394-9600    mprimiano@imppllc.com   
Principal Investigator: Shawn H Zimberg, MD         
Sub-Investigator: Gurmukh Sadarangani, MD         
Advanced Radiation Centers of New York (Integrated Medical Professionals) Recruiting
Hauppauge, New York, United States, 11749
Contact: Kristen Hoffman    631-963-7700 ext 205    khoffman@imppllc.com   
Contact: Michelle Primiano    516-394-9600    mprimiano@imppllc.com   
Principal Investigator: Shawn H Zimberg, MD         
Sub-Investigator: Jigna Jhaveri, MD         
Advanced Radiation Centers of New York (Integrated Medical Professionals) Recruiting
North Hills, New York, United States, 11042
Contact: Kristen Hoffman    631-963-7700 ext 205    khoffman@imppllc.com   
Contact: Michelle Primiano    516-394-9600    mprimiano@imppllc.com   
Principal Investigator: Shawn H Zimberg, MD         
Sub-Investigator: Andrew Pearlman, MD         
Advanced Radiation Centers of New York (Integrated Medical Professionals) Recruiting
Plainview, New York, United States, 11803
Contact: Kristen Hoffman    631-963-7700 ext 205    khoffman@imppllc.com   
Contact: Michelle Primiano    516-394-9600    mprimiano@imppllc.com   
Principal Investigator: Shawn H Zimberg, MD         
Sub-Investigator: Edward Obedian, MD         
Advanced Radiation Centers of New York (Integrated Medical Professionals) Recruiting
The Bronx, New York, United States, 10461
Contact: Kristen Hoffman    631-963-7700 ext 205    khoffman@imppllc.com   
Contact: Michelle Primiano    516-394-9600    mprimiano@imppllc.com   
Principal Investigator: Shawn H Zimberg, MD         
Sub-Investigator: Donald Bronn, MD         
Advanced Radiation Centers of New York (Integrated Medical Professionals) Recruiting
West Nyack, New York, United States, 10994
Contact: Kristen Hoffman    631-963-7700 ext 205    khoffman@imppllc.com   
Contact: Michelle Primiano    516-394-9600    mprimiano@imppllc.com   
Principal Investigator: Shawn H Zimberg, MD         
Sub-Investigator: Arvin Adler, DO         
United States, Texas
Woodland Center Recruiting
The Woodlands, Texas, United States, 77384
Contact: Maegan Elliott    281-351-5174    Maegan.elliott@usoncology.com   
Contact: Chase Authement    281-351-5174    Chase.authement@usoncology.com   
Principal Investigator: Steven W Sukin, MD         
Texas Urology Specialists Recruiting
Tomball, Texas, United States, 77375
Contact: Maegan Elliott    281-351-5174    Maegan.elliott@usoncology.com   
Contact: Chase Authement    281-351-5174    Chase.authement@usoncology.com   
Principal Investigator: Steven W Sukin, MD         
Mexico
Instituto Nacional de Ciencias Medicas y Nutrición, Salvador Subirán Recruiting
Mexico City, Mexico
Contact: Guillermo Feria, MD    +52 (55) 5487 0900      
Sponsors and Collaborators
Advantagene, Inc.
  More Information

Responsible Party: Advantagene, Inc.
ClinicalTrials.gov Identifier: NCT02768363     History of Changes
Other Study ID Numbers: PrTK04
Study First Received: May 6, 2016
Last Updated: May 9, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Advantagene, Inc.:
Immunotherapy
Tumor vaccine
Immuno-oncology
Cytotoxicity
Prostate cancer
Active Surveillance

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on June 27, 2017