Phase II Study of Adenovirus/PSA Vaccine in Men With Recurrent Prostate Cancer After Local Therapy APP21

Completed · Phase 2

Conditions studied: Recurrent Prostate Cancer

In brief

The purpose of this study is to determine whether vaccination with the Ad/PSA vaccine will induce an anti-PSA immunity that will result in the destruction of the remaining prostate cancer cells.

Key facts

Study ID

NCT00583752

Run by

David M Lubaroff

People needed

50

Starts

2007-12-01

Expected to finish

2023-01-31

Last updated by the study team

2023-05-18

Who can join

Age: 18 and older, up to 90. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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 cm).
• Scans must be obtained within 6 weeks of entry into the trial (initiation of treatment).
• Written informed consent.
• Age >/= 18 years.
• Required laboratory values [obtained within 2 weeks of study entry (initiation of treatment)].
• Serum creatinine </= 2.0 mg/dL
• 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 mg/dl (unless bilirubin elevation is consistent with Gilbert's syndrome).
• PSA used as an eligibility criterion must be drawn within 42 days prior to injection number 1 and will be redrawn on Day 1 for use as a baseline value.

You may not qualify if…

• 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.

Where it is running

• Holden Comprehensive Cancer Center — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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