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Phase II Study of Adenovirus/PSA Vaccine in Men With Recurrent Prostate Cancer After Local Therapy

Phase 2
18 Years
90 Years
Open (Enrolling)
Recurrent Prostate Cancer

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Trial Information

Phase II Study of Adenovirus/PSA Vaccine in Men With Recurrent Prostate Cancer After Local Therapy

Subjects will be randomized to Arm A (vaccine only) or Arm B (androgen deprivation therapy
plus vaccine). On Arm A, subjects can begin the three vaccinations immediately. On Arm B,
subjects will be started on androgen deprivation therapy (ADT) 14 days prior to beginning
the vaccinations.

Subjects will be vaccinated three times, each injection administered at 30-day intervals.
Based upon our earlier clinical trial, the vaccine is considered safe and should not induce
any major side effects. The investigators hope that vaccination with this PSA virus will
cause the body to produce immunity to the PSA and that immunity will destroy any cell that
produces PSA. Since the only cells left in the body that produce PSA will be the cancer
cells, the investigators propose that the vaccination and ensuing anti-PSA immunity will
kill the prostate cancer cells. Importantly, this treatment should not cause any major side
effects as would treatment with anti-cancer drugs.

Inclusion Criteria:

- Men with prostate cancer who have received prior local therapy (radical prostatectomy
or definitive radiation therapy) and have biochemical (PSA) relapse without
evidence of radiographic or clinical metastatic disease.

- For men who had prior prostatectomy, the surgery must have occurred at least 6 months
prior to initiation of treatment.

- For men who had prior definitive radiation therapy, radiation must have been
completed at least 1 year prior to initiation of treatment.

- Exhibit at least three separate rises in serum PSA, at least one month apart with
differences >/= 0.03 ng/ml and a total PSA of >0.2 ng/ml.

- Have a PSA doubling time of >/= 6 months if the baseline serum PSA was >2 ng/ml.

- Negative bone scans.

- Negative CT scans of abdomen and pelvis (no evidence of soft tissue lesions >/= 1

- Scans must be obtained within 6 weeks of entry into the trial (initiation of

- Written informed consent.

- Age >/= 18 years.

- Required laboratory values [obtained within 2 weeks of study entry (initiation of

- Serum creatinine
- Adequate hematologic function: granulocytes >/= 1800 per mm3, platelets >/= 100,000
per mm3, WBC >/= 3700, and lymphocytes >/= 590.

- Adequate hepatocellular function: AST <3x upper limit of normal and bilirubin <1.5

- PSA can be used as an eligibility criterion must be drawn within 28 days prior to
injection number 1 and will be redrawn on Day 1 for use as a baseline value.

Exclusion Criteria:

- Candidates for salvage radiation therapy unless the patient refuses.

- Active or unresolved clinically significant infection.

- Parenteral antibiotics <7 days prior to initiation of treatment.

- Evidence of prior or current CNS metastases. Specific imaging is not necessary in the
absence of signs or symptoms.

- Co-morbid medical conditions which would result in a life expectancy (participation)
of less than 1 year.

- Patients with compromised immune systems; congenital, acquired, or drug-induced
(immunosuppressive agents) will be excluded from the study. Use of prednisone at
doses higher than 10 mg daily (or equipotent steroid doses) for more than 7 days
within the last 3 months is not allowed.

- No-pre-existing malignancies that required treatment within the past 5 years except
for basal or squamous cell cancers of the skin.

- Prior systemic therapies for prostate cancer not allowed (hormonal therapy, including
but not limited to LHRH agonists, antiandrogens, ketoconazole or chemotherapy -
mitoxantrone/taxanes/estramustine, etc.) except when patients stopped hormone therapy
two or more years prior to enrollment and currently have normal testosterone levels;
patients in Arm B, undergoing androgen depletion therapy during the vaccination will
be eligible.

- Prior participation in any vaccine studies for non-infectious diseases.

- The inability to understand the language and the clinical protocol.

- Allergy or religious objection to pork products; Gelfoam is produced from pork.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA doubling-time response

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

David M Lubaroff, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Iowa


United States: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

July 2014

Related Keywords:

  • Recurrent Prostate Cancer
  • prostate cancer
  • vaccine
  • immunotherapy
  • Prostatic Neoplasms



Holden Comprehensive Cancer Center Iowa City, Iowa  52242-1009