Evidence map›Paper›PMID 19367257›Full record

Trial reportMolecular therapy : the journal of the American Society of Gene Therapy2009

A phase I/II clinical trial in localized prostate cancer of an adenovirus expressing nitroreductase with CB1954 [correction of CB1984].

Prashant Patel, J Graham Young, Vivien Mautner, Daniel Ashdown, Sarah Bonney, Robert G Pineda, Stuart I Collins, Peter F Searle, Diana Hull, Elizabeth Peers and 6 more

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Molecular therapy : the journal of the American Society of Gene Therapy, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04374240 (Phase I Trial of Replicative Defective Type 5 Adenovirus Vector Expressing Nitroreductase & GMCSF Given Via Trans-perineal Template-guided Intra-prostatic Injection Followed by iv CB1954 in Locally Relapsed Prostate Cancer Patients), which is not on this map. Cited by 48 papers.

0numbers the graph read from it
0cells of the map it votes in
48citing 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.

NCT04374240 phase1completednot on this mapstarted 2013, after this paper: background citation

Phase I Trial of Replicative Defective Type 5 Adenovirus Vector Expressing Nitroreductase & GMCSF Given Via Trans-perineal Template-guided Intra-prostatic Injection Followed by iv CB1954 in Locally Relapsed Prostate Cancer Patients

TypeinterventionalSponsorUniversity of BirminghamRan2013 to 2021Enrolled18ConditionsProstate CancerArmsAdNRGM
3 · Its place in the literature

Who cites it

48 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. A genetic reporter for visualizing nitroreductase activity using magnetic resonance imaging.Chemistry methods : new approaches to solving problems in chemistry · 2026
    Article
  5. Article
  6. Article
  7. Structure and Dynamics of ThreeInternational journal of molecular sciences · 2023
    Article
  8. Prodrugs and prodrug-activated systems in gene therapy.Molecular therapy : the journal of the American Society of Gene Therapy · 2021
    Review
  9. Article
  10. RepurposingTheranostics · 2021
    Article
  11. Engineering theFrontiers in pharmacology · 2021
    Article
  12. Evolutionary aspects of the Viridiplantae nitroreductases.Journal, genetic engineering & biotechnology · 2020
    Article
  13. Article
  14. Extracellular Vesicle-MediatedMolecular cancer therapeutics · 2020
    Article
  15. Article
  16. Article
  17. Review
  18. Hypoxia-targeted drug delivery.Chemical Society reviews · 2019
    Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Prashant PatelCR UK Institute for Cancer Studies, University of Birmingham, UK.
J Graham Young
Vivien Mautner
Daniel Ashdown
Sarah Bonney
Robert G Pineda
Stuart I Collins
Peter F Searle
Diana Hull
Elizabeth Peers
John Chester
D Michael Wallace
Alan Doherty
Hing Leung
Lawrence S Young
Nicholas D James

Funding

Cancer Research UKMedical Research Council
6 · The paper itself

Abstract

We report a phase I/II clinical trial in prostate cancer (PCa) using direct intraprostatic injection of a replication defective adenovirus vector (CTL102) encoding bacterial nitroreductase (NTR) in conjunction with systemic prodrug CB1954. One group of patients with localized PCa scheduled for radical prostatectomy received virus alone, prior to surgery, in a dose escalation to establish safety, tolerability, and NTR expression. A second group with local failure following primary treatment received virus plus prodrug to establish safety and tolerability. Based on acceptable safety data and indications of prostate-specific antigen (PSA) responses, an extended cohort received virus at a single dose level plus prodrug. The vector was well tolerated with minimal side effects, had a short half-life in the circulation, and stimulated a robust antibody response. Immunohistochemistry of resected prostate demonstrated NTR staining in tumor and glandular epithelium at all dose levels [5 x 10(10)-1 x 10(12) virus particles (vp)]. A total of 19 patients received virus plus prodrug and 14 of these had a repeat treatment; minimal toxicity was observed and there was preliminary evidence of change in PSA kinetics, with an increase in the time to 10% PSA progression in 6 out of 18 patients at 6 months.

Indexed as

AdenoviridaeAgedAged, 80 and overAntineoplastic AgentsAziridinesGenetic TherapyGenetic VectorsHumansMaleMiddle AgedNitroreductasesProdrugsProstatic NeoplasmsAntineoplastic AgentsAziridinesNitroreductasesProdrugstretazicar

Identifiers

PMID19367257
PMCPMC2835198

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.