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Recurrent Prostate CancerPhase 2APP21NCT00583752

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

A Phase 2 study testing Adenovirus/PSA Vaccine in people with Recurrent Prostate Cancer, run by David M Lubaroff at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 90 years, men only
Conditions the study is for
Recurrent Prostate Cancer
What is being tested?
Adenovirus/PSA Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Dec 2007to 31 Jan 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
Adenovirus/PSA Vaccine
Keywords
prostate cancer, vaccine, immunotherapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adenovirus/PSA VaccineBiological

    1x10E8pfu in Gelfoam subcutaneously on day 0, 30, 60

Study groups in NCT00583752
Study groupRoleWhat they receive
Androgen deprivation therapy (ADT) + Adenovirus/PSA VaccineExperimentalOn Arm B, subjects will be started on androgen deprivation therapy (ADT) 14 days prior to beginning the vaccinations.
Receives: Biological: Adenovirus/PSA Vaccine
Adenovirus/PSA VaccineExperimentalOn Arm A, subjects can begin the three vaccinations immediately.
Receives: Biological: Adenovirus/PSA Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Develop a Strong or Modest Anti-PSA Immune Response

    Anti-immunologic response is defined as an increase of >200% above pre-immunization levels of anti-PSA T cells as measured by ELISPOT analysis

    Measured: 18 months

Secondary outcomes (2)

  1. Number of Participants With Stable, Decreased, or Increased PSA Doubling Times (PSADT)

    To evaluate the increase, decrease, or stable response rates (PSA responses and changes in PSADT) of the Ad/PSA vaccine using a prime-boost immunization strategy. PSADT will be calculated based on the MSKCC online calculator.

    Measured: 18 months

  2. Number of Participants Alive and Deceased Following Treatment

    To evaluate survival in evaluable patients receiving the Ad/PSA vaccine, as measured by 2-year, 5-year, 10-year, and overall survival (OS)

    Measured: Every 6 months, up to 14 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2007 (estimated)
  2. Study startDec 2007
  3. Primary completion31 Dec 2020
  4. Study completion31 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00583752
Sponsor's protocol ID
201705743
Other IDs
200605706
Acronym
APP21
Status last verified
Apr 2023
First submitted
20 Dec 2007
Last updated
18 May 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Elzey BD, Siemens DR, Ratliff TL, Lubaroff DM. Immunization with type 5 adenovirus recombinant for a tumor antigen in combination with recombinant canarypox virus (ALVAC) cytokine gene delivery induces destruction of established prostate tumors. Int J Cancer. 2001 Dec 15;94(6):842-9. doi: 10.1002/ijc.1556.

    PubMed 11745487

  • Lubaroff DM, Konety B, Link BK, Ratliff TL, Madsen T, Shannon M, Ecklund D, Williams RD. Clinical protocol: phase I study of an adenovirus/prostate-specific antigen vaccine in men with metastatic prostate cancer. Hum Gene Ther. 2006 Feb;17(2):220-9. doi: 10.1089/hum.2006.17.220. No abstract available.

    PubMed 16454655

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adenovirus/PSA Vaccine in people with Recurrent Prostate Cancer, run by David M Lubaroff at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Develop a Strong or Modest Anti-PSA Immune Response (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00583752, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.

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