NCT00005916

PSA-Based Vaccine and Radiotherapy to Treat Localized Prostate Cancer

Completed Phase 2 Last updated 2 July 2017

What this trial tests

Phase 2 trial testing rV-PSA in Prostate Cancer in 48 participants. Completed in 22 December 2005.

Timeline

13 June 2000

22 December 2005

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Primary purpose	treatment
Enrollment	48
Start date	13 June 2000
Estimated completion	22 December 2005
Sites	1 location across United States

Drugs / interventions tested

• rV-PSA — full drug profile →
• rF-PSA — full drug profile →
• rV-B7.1 — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →
• Prostate Neoplasm — all drugs for Prostate Neoplasm →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, male only, with Prostate Cancer or Prostate Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will test the ability of an experimental vaccine to increase the number of tumor-fighting immune cells (lymphocytes) in patients with localized prostate cancer and prevent the disease from recurring following radiation therapy. The vaccine is intended to stimulate lymphocytes to target and attack cells containing a protein called prostate specific antigen, or PSA. It is composed of the following parts:

* rV-PSA: Vaccinia virus plus human DNA that produces PSA (prostate specific antigen)
* rV-B7.1: Vaccinia virus plus human DNA that produces B7.1 (a protein that helps guide immune cells to their targets)
* rF-PSA: Fowlpox virus plus human DNA that produces PSA
* GM-CSF: Drug that boosts the immune system.
* IL-2: Drug that boosts the immune system.

Patients 18 years of age and older with prostate cancer confined to the prostate who have received a smallpox vaccine sometime in the past and who do not have a history of allergy to eggs may be eligible for this study. Candidates are screened with a complete medical history and physical examination, blood tests, and skin tests (similar to those for allergies or tuberculosis) to assess immune function.

Participants are randomly assigned to receive one of the following three treatments: Group 1 - standard radiation therapy plus the experimental vaccine; Group 2 - standard radiation therapy without the vaccine; Group 3 - standard radiation therapy with the vaccine, but with a different dose of IL-2 from Group 1.

Patients in the vaccine groups receive injections in the arm or thigh in 28-day treatment cycles, as follows:

* GM-CSF: Days 1 through 4 of the first week
* IL-2 5: for Group 1, 5 days in the second week of each cycle; for Group 3, 14 days beginning in the second week of each cycle
* rV-PSA and rV-B7.1: Day 2 of the first cycle only
* rF-PSA (booster shots): Every 28 days, beginning day 2 of the second cycle (i.e., days 30, 58, 86, etc.)

Treatment continues for eight cycles unless serious side effects develop, PSA levels rise significantly, or the doctors feel there is no reason to continue therapy.

All patients undergo radiation therapy and possibly hormone therapy, if indicated. Blood samples are drawn once a week for the first month and then once every 4 weeks to monitor safety. After treatment ends, patients are followed with examinations and blood tests every 3 months for the first 2 years and then every 6 months until the doctors determine follow-up is no longer needed or the cancer returns.

All patients have HLA tissue typing at the beginning of the study. Those who are type HLA-A2 are asked to have additional procedures for studying the immune response that can be done only with this tissue type. This involves collecting blood samples before treatment begins, every 4 weeks during treatment, once after cycle 2, and once 4 months after the eighth vaccine. They also undergo four leukapheresis procedures for collecting white blood cells. For leukapheresis, blood is collected through a needle in an arm vein, similar to donating a unit of blood. The blood flows through a machine that separates it into its components. The white cells are removed, and the red cells, platelets and plasma are returned to the body, either through the same needle or through a needle in the other arm.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Technologies for enhanced efficacy of DNA vaccines.
   Saade F, Petrovsky N. · · 2012 · cited 232× · PMID 22309668 · DOI 10.1586/erv.11.188
2. Immune impact induced by PROSTVAC (PSA-TRICOM), a therapeutic vaccine for prostate cancer.
   Gulley JL, Madan RA, Tsang KY, Jochems C, et al · · 2014 · cited 104× · PMID 24778277 · DOI 10.1158/2326-6066.cir-13-0108
3. Radiotherapy in Combination With Cytokine Treatment.
   Palata O, Hradilova Podzimkova N, Nedvedova E, Umprecht A, et al · · 2019 · cited 39× · PMID 31179236 · DOI 10.3389/fonc.2019.00367
4. Immune Modulation by Androgen Deprivation and Radiation Therapy: Implications for Prostate Cancer Immunotherapy.
   Kalina JL, Neilson DS, Comber AP, Rauw JM, et al · · 2017 · cited 37× · PMID 28134800 · DOI 10.3390/cancers9020013
5. Cancer vaccines: platforms and current progress.
   Lei W, Zhou K, Lei Y, Li Q, et al · · 2025 · cited 19× · PMID 39789208 · DOI 10.1186/s43556-024-00241-8
6. Poxviral-based vaccine elicits immunologic responses in prostate cancer patients.
   Madan RA, Heery CR, Gulley JL. · · 2014 · cited 14× · PMID 25097802 · DOI 10.4161/onci.28611
7. Targeted Radiation and Immune Therapies-Advances and Opportunities for the Treatment of Prostate Cancer.
   Muralidhar A, Potluri HK, Jaiswal T, McNeel DG. · · 2023 · cited 7× · PMID 36678880 · DOI 10.3390/pharmaceutics15010252
8. The Current and Future Promises of Combination Radiation and Immunotherapy for Genitourinary Cancers.
   Saidian A, Dolendo I, Sharabi A, Stewart TF, et al · · 2022 · cited 4× · PMID 36612124 · DOI 10.3390/cancers15010127