NCT03579654

Study of Proscavax Vaccine in Patients With Localized Prostate Cancer vs Active Surveillance

Status unknown Phase 2 Last updated 6 March 2019

What this trial tests

Phase 2 trial testing Proscavax in Prostate Cancer in 120 participants. Status unknown.

Timeline

28 February 2019

Primary endpoint
28 February 2021

30 June 2022

Quick facts

Lead sponsor	OncBioMune Pharmaceuticals
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	28 February 2019
Primary completion	28 February 2021
Estimated completion	30 June 2022
Sites	2 locations across United States

Drugs / interventions tested

• Proscavax — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

OncBioMune Pharmaceuticals — full company profile →

Who can join

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

Sponsor's own description

This study will evaluate the safety and efficacy of a prostate cancer vaccine named Proscavax (Prostate-specific antigen(PSA) / Interleukin-2(IL-2) / Granulocyte-macrophage colony-stimulating factor(GM-CSF)) in patients with localized prostate cancer. The goal of the study is to determine if vaccine administration results in a change in the rate of prostate cancer progression when compared to a no-treatment control group of active surveillance patients.

The researchers are interested in evaluating the proportion of participants with prostate cancer progression at 2 years following administration of Proscavax or active surveillance, the effect of the vaccine on prostate-specific antigen (PSA) doubling time and the assessment of adverse events in these patients.

Eligible patients in this study will include men who are 18 years and older and who have a previously untreated early stage prostate cancer regardless of the date of diagnosis.

Publications & conference data

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

1. Cancer vaccines as promising immuno-therapeutics: platforms and current progress.
   Liu J, Fu M, Wang M, Wan D, et al · · 2022 · cited 497× · PMID 35303904 · DOI 10.1186/s13045-022-01247-x
2. A systematic review of interleukin-2-based immunotherapies in clinical trials for cancer and autoimmune diseases.
   Raeber ME, Sahin D, Karakus U, Boyman O. · · 2023 · cited 139× · PMID 37004361 · DOI 10.1016/j.ebiom.2023.104539
3. Immunotherapy in Prostate Cancer.
   Fay EK, Graff JN. · · 2020 · cited 70× · PMID 32630247 · DOI 10.3390/cancers12071752
4. Macrophages as a Therapeutic Target in Metastatic Prostate Cancer: A Way to Overcome Immunotherapy Resistance?
   Martori C, Sanchez-Moral L, Paul T, Pardo JC, et al · · 2022 · cited 43× · PMID 35053602 · DOI 10.3390/cancers14020440
5. Recent Advances in Cancer Vaccines: Challenges, Achievements, and Futuristic Prospects.
   Gupta M, Wahi A, Sharma P, Nagpal R, et al · · 2022 · cited 41× · PMID 36560420 · DOI 10.3390/vaccines10122011
6. Immunotherapy in prostate cancer: new horizon of hurdles and hopes.
   Tsaur I, Brandt MP, Juengel E, Manceau C, et al · · 2021 · cited 19× · PMID 33106940 · DOI 10.1007/s00345-020-03497-1
7. Bidirectional crosstalk between therapeutic cancer vaccines and the tumor microenvironment: Beyond tumor antigens.
   Zhang SW, Wang H, Ding XH, Xiao YL, et al · · 2023 · cited 9× · PMID 38933006 · DOI 10.1016/j.fmre.2022.03.009
8. Recent Findings on Therapeutic Cancer Vaccines: An Updated Review.
   Sheikhlary S, Lopez DH, Moghimi S, Sun B. · · 2024 · cited 8× · PMID 38672519 · DOI 10.3390/biom14040503