Clinical Trials /

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

NCT02772562

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse After Radical Prostatectomy
  • Official Title: A Phase II Trial of Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse After Radical Prostatectomy

Clinical Trial IDs

  • ORG STUDY ID: 102377
  • NCT ID: NCT02772562

Conditions

  • Prostatic Neoplasms

Interventions

DrugSynonymsArms
PROSTVAC-V/FPROSTVAC-V/F

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
PROSTVAC-V/FExperimental
  • PROSTVAC-V/F

Eligibility Criteria

        Inclusion Criteria:

          1. Age >21

          2. Completed radical prostatectomy for pathologically-verified adenocarcinoma of the
             prostate no more than 120 days prior to start of treatment. The following procedures
             are acceptable: radical retropubic prostatectomy (RRP), laparoscopic radical
             prostatectomy (with or without robotic assistance; LAPD), radical perineal
             prostatectomy (RPP).

          3. Post-operative PSA <0.2ng/mL by 120 days after prostatectomy

          4. 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

               -  presence of any tertiary Gleason 5 component on the prostatectomy pathology
                  report.

             Note: Patients with pT3a disease who lack one of the above criteria, and who refuse
             adjuvant radiation, may also be enrolled.

          5. ECOG performance status 0-1

          6. Adequate hematologic, renal, liver function per parameters in Table 1

          7. Subject of fathering potential must agree to 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.

          8. 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:

          1. Pure small cell carcinoma of the prostate

          2. Radiographically-demonstrable metastases at any time prior to the time of enrollment

          3. Diagnosis of cancer requiring systemic therapy in the past 5 years

          4. Presence of any major medical condition which, in the opinion of the investigator,
             precludes participation in the study

          5. Neoadjuvant or adjuvant therapy of any kind

          6. 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.

          7. Use of systemic immunosuppressant agents including anti-metabolites, glucocorticoids,
             TNF antagonists, antibodies to IL6 or IL6R, calcineurin inhibitors, mTOR antagonists

          8. Prior history of serious toxicity or a systemic reaction to vaccinia immunization such
             as myopericarditis progressive vaccinia infection, or eczema vaccinatum.

          9. Inflammatory or exfoliative skin diseases such as eczema, psoriasis that disrupt
             epidermis

         10. Active infections requiring systemic therapy

         11. Serologic evidence of HIV/AIDS.

         12. Positive hepatitis C serology or active hepatitis B infection.

         13. History of allergy to eggs, egg products, aminoglycoside antibiotics

         14. History of myocardial disease, such as myocarditis, cardiomyopathy, congestive heart
             failure, ischemic cardiomyopathy

         15. Prior solid organ or stem cell transplant

         16. 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, or Addison's
             disease). Persons with vitiligo, Hashimoto's thyroiditis, or Graves disease are not
             excluded.

         17. 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.

         18. 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.

         19. 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:21 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Anti-tumor effect of PROSTVAC-V/F
Time Frame:2 years
Safety Issue:
Description: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

Measure:Observed relapse free survival (RFS) with the predicted "virtual" RFS of each patient.
Time Frame:2 years
Safety Issue:
Description: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.
Measure:Observed relapse free survival (RFS) with the RFSs of a historical comparison group of MUSC prostatectomy patients.
Time Frame:2 years
Safety Issue:
Description:
Measure:Associations between RFS values and research specimen
Time Frame:2 years
Safety Issue:
Description:
Measure:Frequency of adverse events as assessed by CTCAE v. 4
Time Frame:2 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Medical University of South Carolina

Trial Keywords

  • prostate cancer

Last Updated

October 1, 2019