Evidence map›Paper›PMID 41781018›Full record

Trial reportJournal for immunotherapy of cancer2026

Androgen deprivation, androgen receptor-targeted vaccination, and nivolumab in patients with high-risk localized prostate cancer.

David Jarrard, Jens Eickhoff, Christos E Kyriakopoulos, Donghwan Jeon, Tommaso P Tonelli, Laura Johnson, Wei Huang, Douglas G McNeel

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Journal for immunotherapy of 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 NCT04989946 (Phase I/II Trial of Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04989946 phase1 / phase2active not recruitingnot on this map

Phase I/II Trial of Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer

TypeinterventionalSponsorUniversity of Wisconsin, MadisonRan2021 to 2028Enrolled57ConditionsProstate CancerArmsDegarelix, pTVG-AR, Nivolumab, Cemiplimab, Fianlimab
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

David JarrardCarbone Comprehensive Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin, USA.
Jens EickhoffCarbone Comprehensive Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin, USA.
Christos E KyriakopoulosCarbone Comprehensive Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin, USA.
Donghwan JeonCarbone Comprehensive Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin, USA.
Tommaso P TonelliCarbone Comprehensive Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin, USA.
Laura JohnsonCarbone Comprehensive Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin, USA.
Wei HuangCarbone Comprehensive Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin, USA.
Douglas G McNeelCarbone Comprehensive Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin, USA dm3@medicine.wisc.edu.ORCID http://orcid.org/0000-0003-1471-6723

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn murine studies, we demonstrated that a DNA vaccine encoding the androgen receptor (pTVG-AR) given prior to androgen deprivation elicited prostate tumor-infiltrating lymphocytes and an antitumor response. The current trial evaluated this approach, with or without programmed cell death protein-1 (PD-1) blockade, in patients with high-risk newly diagnosed prostate cancer.

methodsIn the first stage of a two-stage protocol, 24 patients were randomized to treatment with (1) degarelix alone (n=6); (2) pTVG-AR followed by degarelix (n=9); or (3) pTVG-AR, degarelix and nivolumab (n=9), each delivered over 12 weeks prior to prostatectomy. The primary objectives were safety and pathological complete response or minimal residual disease (MRD). Secondary endpoints were residual cancer burden (RCB) <0.25 cm

resultsAdverse events were almost exclusively in Arm 3, attributed to nivolumab. One patient achieved MRD (Arm 2), and three patients had an RCB <0.25 cm

conclusionIn this first stage of a pilot study that awaits confirmation with larger numbers of patients, our results suggest that vaccination targeting AR given prior to androgen deprivation therapy might improve outcome for patients with high-risk prostate cancer. Contrary to our initial hypothesis, this was not improved with the addition of PD-1 blockade, possibly due to the activation of regulatory CD4+T cells. TRIAL REGISTRATION NUMBER: NCT04989946.

Indexed as

Androgen AntagonistsCancer VaccinesNivolumabProstatic NeoplasmsReceptors, AndrogenAgedHumansMaleMiddle AgedAndrogen AntagonistsCancer VaccinesNivolumabReceptors, AndrogenNivolumabProstate CancerT regulatory cell - TregTumor infiltrating lymphocyte - TILVaccine

Identifiers

PMID41781018
PMCPMC12970092

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.