Trial reportClinical genitourinary cancer2026
Overall Survival of Patients With PSA-Recurrent Prostate Cancer: Long-Term Analysis of a Randomized Phase 2 Trial of pTVG-HP DNA Vaccine Versus Placebo.
Trial report in Clinical genitourinary cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01341652 (Randomized Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Randomized Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) Versus GM-CSF Adjuvant in Patients With Non-Metastatic Prostate Cancer
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4 authors.
Funding
Abstract
backgroundWe previously reported results from a randomized phase 2 trial evaluating a DNA vaccine (pTVG-HP) encoding prostatic acid phosphatase (PAP) versus placebo (GM-CSF vaccine adjuvant alone) in patients with PSA-recurrent, nonmetastatic, noncastrate prostate cancer (NCT01341652). The primary endpoint of 2-year metastasis-free survival (MFS) was not different between the treatment arms. This trial was reopened for long-term evaluation. METHODS AND
resultsThe median follow-up for long-term overall survival was 4.1 years (range 0.1-13.8+ years). Median overall survival of 48 patients treated with pTVG-HP was 13.4 years versus 8.6 years for 49 patients treated with placebo (hazard ratio [HR] = 0.42, 95% confidence interval [CI], 0.20-0.90). Long-term follow-up information on survival and subsequent treatments was available for 59 patients treated at one site. Of these, 56 were treated with subsequent androgen deprivation therapy (ADT). When analyzing overall survival for this cohort, the adjusted HR was 0.60 (95% CI, 0.36-1.00) when comparing pTVG-HP versus placebo, after adjusting for baseline characteristics and for ADT and subsequent treatment exposure. The median time to beginning ADT was 2.2 years for patients randomized to pTVG-HP versus 1.4 years for patients randomized to placebo. The median time to the next therapy for castration-resistant disease after beginning ADT was 4.7 years for patients randomized to pTVG-HP versus 2.1 years for patients randomized to placebo.
conclusionsThese results suggest that pTVG-HP may have had a single-agent benefit that could not be appreciated using an MFS endpoint. This is consistent with results from other trials of anticancer vaccines, which suggest that these may have more impact on longer-term endpoints such as survival.
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