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Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse After Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT02772562
Recruitment Status : Recruiting
First Posted : May 13, 2016
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
Bavarian Nordic, Inc.
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
The purpose of this study is to see how well PROSTVAC -V/F works in stopping prostate cancer from coming back or relapsing. This study will also look at the safety of PROSTVAC-V/F.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Biological: PROSTVAC-V/F Phase 2

Detailed Description:
This study is for adult male patients who have recently undergone radical prostatectomy and are at high risk for relapse. The purpose of this study is to look at the effect PROSTVAC-V/F has in preventing or prolonging relapse after surgery. PROSTVAC-V/F is an investigational drug.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse After Radical Prostatectomy
Study Start Date : July 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: PROSTVAC-V/F Biological: PROSTVAC-V/F

0.5 ml containing at least 2 x 108 Infectious Units (Inf.U) PROSTVAC-V given on day 1.

0.5 ml containing at least 1 x 109 Inf.U PROSTVAC-F given on days 15, 28, 57, 85, 113, 141.





Primary Outcome Measures :
  1. Anti-tumor effect of PROSTVAC-V/F [ Time Frame: 2 years ]
    Anti-tumor effect of PROSTVAC-V/F will be determined by the number of subjects experiencing relapse at the two year follow up visit after prostatectomy.


Secondary Outcome Measures :
  1. Observed relapse free survival (RFS) with the predicted "virtual" RFS of each patient. [ Time Frame: 2 years ]
    The predicted RFS values will be calculated from each patient's clinicl and pathologic data by a risk adapted algorithm. The observed and predicted RFSs will be presented as Kaplan-Meier plots and comparisons will be done by the longrank test.

  2. Observed relapse free survival (RFS) with the RFSs of a historical comparison group of MUSC prostatectomy patients. [ Time Frame: 2 years ]
  3. Associations between RFS values and research specimen [ Time Frame: 2 years ]
  4. Frequency of adverse events as assessed by CTCAE v. 4 [ Time Frame: 2 years ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >/= 21 and willing to give consent
  • Completed radical prostatectomy for pathologically-verified adenocarcinoma of the prostate no more than 120 days prior to enrollment.
  • Post-operative PSA <0.2ng/mL by 120 days after prostatectomy
  • Must have one or more of the following: pT3b or pT4 primary tumor; Gleason score 8-10; pN1 lymph node disease; positive surgical margins; pre-operative PSA of > 10ng/mL Patients with pT3a disease who lack one of the above criteria, and who refuse adjuvant radiation, may also be enrolled.
  • ECOG performance status 0-1
  • Adequate hematologic, renal, liver function as outlined in the protocol.
  • Subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study and for at least 4 weeks after the last dose of study drug to minimize the risk of pregnancy.
  • Subjects must have had a negative bone scan, and CT of abdomen and pelvis within 16 weeks prior to registration. Additional forms of imaging (Prostascint scan, MRI) may be substituted for a CT scan of the abdomen and pelvis if clinically indicated.

Exclusion Criteria:

  • Pure small cell carcinoma of the prostate
  • Radiographically-demonstrable metastases at any time prior to the time of enrollment
  • Diagnosis of cancer requiring systemic therapy in the past 5 years
  • Presence of any major medical condition which, in the opinion of the investigator, precludes participation in the study
  • Neoadjuvant or adjuvant therapy of any kind
  • Chronic administration (defined as daily or every other day for continued use > 14 days) of systemic glucocorticoids within 28 days of the first planned dose of PROSTVAC-V/F. Use of inhaled steroids, nasal sprays, and all topical preparations (creams, solutions, gels, ointments, etc.) for up to 5% of the body surface area is allowed.
  • Use of systemic immunosuppressant agents including anti-metabolites, glucocorticoids, TNF antagonists, antibodies to IL6 or IL6R, calcineurin inhibitors, mTOR antagonists
  • Prior history of serious toxicity or a systemic reaction to vaccinia immunization such as myopericarditis progressive vaccinia infection, or eczema vaccinatum.
  • Inflammatory or exfoliative skin diseases such as eczema, psoriasis that disrupt epidermis
  • Active infections requiring systemic therapy
  • Serologic evidence of HIV/AIDS.
  • Positive hepatitis C serology or active hepatitis B infection.
  • History of allergy to eggs, egg products, aminoglycoside antibiotics
  • History of myocardial disease, such as myocarditis, cardiomyopathy, congestive heart failure, ischemic cardiomyopathy
  • Prior solid organ or stem cell transplant
  • History of or active autoimmune disease (e.g., autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus, localized lupus, Sjogren's syndrome, scleroderma, myasthenia gravis, Goodpasture's syndrome, Addison's disease, Hashimoto's thyroiditis, or Graves disease). Persons with vitiligo are not excluded.
  • Uncontrolled diabetes. Subjects with diabetes mellitus are not excluded if the condition is well-controlled (A1C < 7.5).
  • Vaccination with live attenuated vaccine within 28 days prior to day 1 of PROSTVAC-V/F administration or vaccination with a killed vaccine within 14 days prior to day 1 of PROSTVAC-V/F.
  • Inability to avoid close contact or household contact with the following high-risk individuals for three weeks after the Day 1 vaccination or until the vaccination site heals completely: (a) children ≤ 3 years of age; (b) pregnant or nursing women; (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders; or (d) immunocompromised individuals, such as those with HIV.
  • Any condition which, in the opinion of the investigator, would prevent full participation in this trial (including Follow-Up), or would interfere with the evaluation of the trial endpoints.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772562


Contacts
Contact: Mike Wheeler 843-792-9321 hcc-clinical-trials@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Michael Lilly, MD    843-792-4271      
Contact: Mike Wheeler    843-792-9321    hcc-clinical-trials@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Bavarian Nordic, Inc.
Investigators
Principal Investigator: Michael Lilly, MD Medical University of South Carolina

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02772562     History of Changes
Other Study ID Numbers: 102377
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Medical University of South Carolina:
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases