Evidence map›Paper›PMID 36210487›Full record

Trial reportThe oncologist2023

Black Patients with Metastatic Castrate-Resistant Prostate Cancer Have a Shorter Time Interval Between PSA and Clinical Progression on Novel Hormonal Therapies plus Avelumab.

Charlotte Manogue Hawkins, Pedro C Barata, Patrick Cotogno, Gaynelle Davis, Ellen Jaeger, Elisa Ledet, Patrick Miller, Brian Lewis, Oliver Sartor, Jodi Layton

Registry-linked trialOpen access · goldFull text readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03770455 (PDL-1 Inhibition With Avelumab and Concurrent Second-generation ADT in African Americans With Castrate-resistant Metastatic Prostate Cancer), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 35% of its field
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.

NCT03770455 phase2terminatednot on this map

PDL-1 Inhibition With Avelumab and Concurrent Second-generation ADT in African Americans With Castrate-resistant Metastatic Prostate Cancer

TypeinterventionalSponsorJodi Layton, MDRan2019 to 2021Enrolled8ConditionsMetastatic Castration-resistant Prostate CancerArmsAvelumab, 2nd generation ADT (abiraterone or enzalutamide)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Review
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

10 authors at 1 institution in 1 country.

Charlotte Manogue HawkinsTulane Office of Clinical Research, Tulane School of Medicine, New Orleans, LA, USA.
Pedro C BarataTulane School of Medicine, New Orleans, LA, USA.ORCID 0000-0002-8890-2951
Patrick CotognoTulane Office of Clinical Research, Tulane School of Medicine, New Orleans, LA, USA.
Gaynelle DavisTulane Office of Clinical Research, Tulane School of Medicine, New Orleans, LA, USA.
Ellen JaegerTulane Office of Clinical Research, Tulane School of Medicine, New Orleans, LA, USA.
Elisa LedetTulane Office of Clinical Research, Tulane School of Medicine, New Orleans, LA, USA.
Patrick MillerTulane Office of Clinical Research, Tulane School of Medicine, New Orleans, LA, USA.
Brian LewisTulane School of Medicine, New Orleans, LA, USA.
Oliver SartorTulane School of Medicine, New Orleans, LA, USA.
Jodi LaytonTulane School of Medicine, New Orleans, LA, USA.ORCID 0000-0002-7545-8601
Tulane University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBlack men are at higher risk for prostate cancer death. Previous studies showed a benefit of different therapies, including immune-based therapy, for Black men with metastatic prostate cancer. We sought to explore the efficacy of the PD-L1 inhibitor avelumab in Black men with metastatic castrate-resistant prostate cancer (mCRPC) progressing after abiraterone or enzalutamide.

methodsThis pilot phase II study enrolled self-identified Black patients who developed mCRPC on next-generation hormonal therapies (NHTs) abiraterone acetate or enzalutamide (NCT03770455). Enrolled patients received avelumab 10mg/kg IV every 2 weeks while remaining on the same NHTs. The primary endpoint of our study was ≥ 50% reduction in prostate specific antigen (PSA) at ≥8 weeks.

resultsA total of eight patients were enrolled. The median duration on NHTs prior to enrollment was 364 days (95% CI, 260.9-467.1). The median time to initiate avelumab was 8 days (3-14). With a median follow-up of 196 days, no patients achieved the primary endpoint. The median time to PSA progression was 35 days (95 CI%, 0-94.8) and the median time to radiographic and/or clinical progression was 44 days (95 CI%, 0-118.5). The study was closed prematurely due to safety concerns related to the rapid clinical progression observed in the patients enrolled on study.

conclusionIn conclusion, the addition of avelumab to NHT did not demonstrate clinical activity in Black men with new mCRPC. The unexpected short interval between PSA and radiographic and/or clinical progression observed in this study has potential clinical implications.ClinicalTrials.gov Identifier: NCT03770455 (IND number 139559).

Indexed as

Prostate-Specific AntigenProstatic Neoplasms, Castration-ResistantAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBenzamidesDisease ProgressionHumansMaleNitrilesPhenylthiohydantoinTreatment OutcomeAntibodies, Monoclonal, HumanizedavelumabBenzamidesenzalutamideNitrilesPhenylthiohydantoinProstate-Specific AntigenavelumabBlack/African Americanmetastatic castrate-resistant prostate cancermetastatic prostate cancer

Identifiers

PMID36210487
PMCPMC10020796
OpenAlexW4303986762

What Socratic holds

Textfull text, public
LicenceCC BY
measurements read8
identifiers read3
Read underepoch 390

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 Socratic graph.