Flutamide With or Without PROSTVAC in Non-metastatic Castration Resistant (M0) Prostate Cancer

Ravi A. Madan*, Marijo Bilusic, Mark N. Stein, Renee N. Donahue, Philip M. Arlen, Fatima Karzai, Elizabeth Plimack, Yu Ning Wong, Daniel M. Geynisman, Matthew Zibelman, Tina Mayer, Julius Strauss, Gang Chen, Myrna Rauckhorst, Sheri Mcmahon, Anna Couvillon, Seth Steinberg, William D. Figg, William L. Dahut, Jeffrey SchlomJames L. Gulley

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Scopus citations


Background: Before 2018, there was no standard of care for non-metastatic (M0) castration resistant prostate cancer nmCRPC. Androgen receptor antagonists (ARAs) were commonly used sequentially nmCRPC. Methods: This was a multicenter, randomized clinical trial comparing the ARA flutamide+/-PROSTVAC, a pox viral vaccine targeting PSA that includes T-cell co-stimulatory molecules. Eligible men had negative CT and Tc99 bone scans, and rising PSA on ADT. Previous treatment with ARA was a stratification factor. Patients were also evaluated for antigen-specific immune responses using intracellular cytokine staining. Results: Thirty-three patients randomized to flutamide and 31 to flutamide+vaccine. The median age was 71.8 and 69.8 years, respectively. The median time to treatment failure after a median potential follow-up of 46.7 months was, 4.5 months (range 2-70) for flutamide alone vs. 6.9 months (2.5-40; P =. 38) with flutamide+vaccine. Seven patients in each arm had a >50% PSA response. Antigen-specific responses were similar in both arms (58% of patients in flutamide alone and 56% in flutamide+vaccine). The treatments were well tolerated. The most common side effect > grade 2 was injection site reaction seen in 29/31 vaccine patients which were self-limiting. Conclusion: The combination of flutamide+PROSTVAC did not improve outcomes in men with nmCRPC compared with flutamide alone. (ClinicalTrials.gov Identifier: NCT00450463).

Original languageEnglish
Pages (from-to)642-E561
Issue number7
StatePublished - 1 Jul 2023
Externally publishedYes


  • anti-androgen therapy
  • cancer vaccine
  • immunotherapy
  • prostate cancer


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