Evidence map›Paper›PMID 38515274›Full record

ArticleClinical and translational medicine2024

A phase I study of docetaxel plus synthetic lycopene in metastatic prostate cancer patients.

Michael B Lilly, Chunli Wu, Yu Ke, Wen-Pin Chen, Adam C Soloff, Kent Armeson, Noriko N Yokoyama, Xiaotian Li, Liankun Song, Ying Yuan and 2 more

Open access · goldAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical and translational medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
3.7field-weighted citation impact, top 6% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 13 citations in OpenAlex.

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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

12 authors at 4 institutions in 1 country.

Michael B LillyHollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA.
Chunli WuDepartment of Urology, University of California, Irvine, California, USA.
Yu KeDepartment of Urology, University of California, Irvine, California, USA.
Wen-Pin ChenChao Family Comprehensive Cancer Center, University of California, Irvine, California, USA.
Adam C SoloffDepartment of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Kent ArmesonHollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA.
Noriko N YokoyamaDepartment of Urology, University of California, Irvine, California, USA.
Xiaotian LiDepartment of Urology, University of California, Irvine, California, USA.
Liankun SongDepartment of Urology, University of California, Irvine, California, USA.
Ying YuanDepartment of Biostatistics, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.
Christine E McLarenChao Family Comprehensive Cancer Center, University of California, Irvine, California, USA.
Xiaolin ZiDepartment of Urology, University of California, Irvine, California, USA.ORCID 0000-0002-5312-7158
University of California, Irvine · USMedical University of South Carolina · USThe University of Texas MD Anderson Cancer Center · USUniversity of Pittsburgh · US

Funding

Univ.of Calif., Irvine Cancer Center Support GrantP30CA062203 · NCI · UNIVERSITY OF CALIFORNIA-IRVINE · PI Melanie Funes · 1994 to 2026
$57.9M
Translational Science Laboratory Shared ResourceP30CA138313 · NCI · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI Jian Ouyang · 2009 to 2026
$42.7M
University of California Health Participation in the National COVID Cohort Collaborative (N3C)UL1TR001414 · NCATS · UNIVERSITY OF CALIFORNIA-IRVINE · PI COOPER, DAN M, VILAIN, ERIC J. · 2015 to 2023
$35.1M
Ethnicity-determined T cell responses and GARP/TGFbeta1 signaling in prostate cancerR01CA260351 · NCI · UNIVERSITY OF CALIFORNIA-IRVINE · PI Anshu Agrawal, Xiaolin Zi · 2022 to 2026
$1.8M
Phase 1 Bioassay-guided Trial of Lycopene and Docetaxel for Prostate CancerR21CA166839 · NCI · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI LILLY, MICHAEL B, ZI, XIAOLIN · 2013 to 2014
$369k
A novel targetable mechanism for castration-resistant prostate cancerI01BX005105 · VA · VETERANS HEALTH ADMINISTRATION · PI ZI, XIAOLIN · 2022 to 2025
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BLRD VA I01 BX005105NCATS NIH HHS UL1 TR001414NCI NIH HHS 1R01CA260351NCI NIH HHS 1R21CA166839NCI NIH HHS P30 CA062203NCI NIH HHS P30 CA138313NCI NIH HHS R01 CA260351NCI NIH HHS R21 CA166839
6 · The paper itself

Abstract

purposeOur preclinical studies showed that lycopene enhanced the anti-prostate cancer efficacy of docetaxel in animal models. A phase I trial (NCT0149519) was conducted to identify an optimum dose of synthetic lycopene in combination with docetaxel (and androgen blockade [androgen deprivation therapy, ADT]), and to evaluate its effect on the safety and pharmacokinetics of docetaxel in men with metastatic prostate cancer.

methodsSubjects were treated with 21-day cycles of 75 mg/m

resultsTwenty-four participants were enrolled, 18 in a dose escalation cohort to define the maximum tolerated dose (MTD), and six in a pharmacokinetic cohort. Docetaxel/ADT plus 150 mg/day synthetic lycopene resulted in dose-limiting toxicity (pulmonary embolus) in one out of 12 participants with an estimated probability of .106 and thus was chosen as the MTD. Lycopene increased the AUC

conclusionsThe combination of docetaxel/ADT and synthetic lycopene has low toxicity and favourable pharmacokinetics. The effects of lycopene on biomarkers provide additional support for the toxicity-dependent MTD definition. HIGHLIGHTS: The maximum tolerated dose was identified as 150 mg/day of lycopene in combination with docetaxel/ADT for the treatment of metastatic prostate cancer patients. Small increases in plasma exposure to docetaxel were observed with lycopene co-administration. Mechanistically significant effects were seen on angiogenesis and insulin-like growth factor 1 signalling by lycopene co-administration with docetaxel/ADT.

Indexed as

Prostatic NeoplasmsAndrogen AntagonistsAndrogensBayes TheoremDocetaxelEndothelial CellsHumansLycopeneMaleVascular Endothelial Growth Factor AAndrogen AntagonistsAndrogensDocetaxelLycopeneVascular Endothelial Growth Factor Adocetaxellycopenephase I trialprostate cancer

Identifiers

PMID38515274
PMCPMC10958125
OpenAlexW4393097996

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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.