Evidence map›Paper›PMID 24598155›Full record

Trial reportJournal of hematology & oncology2014

Long-term results of a phase II study with neoadjuvant docetaxel chemotherapy and complete androgen blockade in locally advanced and high-risk prostate cancer.

Mark Thalgott, Thomas Horn, Matthias M Heck, Tobias Maurer, Matthias Eiber, Margitta Retz, Michael Autenrieth, Kathleen Herkommer, Bernd J Krause, Jürgen E Gschwend and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of hematology & oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04220398 (A Prospective, Multicenter, Three-arm, Randomized, Controlled Study Comparing the Efficacy of Neoadjuvant Hormonal Therapy Combined With Systemic Chemotherapy), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
4.1field-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.

NCT04220398 naunknown statusnot on this mapstarted 2020, after this paper: background citation

A Prospective, Multicenter, Three-arm, Randomized, Controlled Study Comparing the Efficacy of Neoadjuvant Hormonal Therapy Combined With Systemic Chemotherapy (NCHT), Neoadjuvant Hormonal Therapy (NHT) and Radical Prostatectomy Only in Locally Advanced Prostate Cancer

TypeinterventionalSponsorRenJi HospitalRan2020 to 2024Enrolled475ConditionsProstate Cancer, Chemotherapy Effect, Hormone Sensitive Prostate Cancer, Locally Advanced Prostate CarcinomaArmsNeoadjuvant chemotherapy combined with hormone therapy, Neoadjuvant hormone therapy, Radical Prostatectomy (RP)+ extended lymph node dissection
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.

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  7. Head-to-head comparisons of [European journal of nuclear medicine and molecular imaging · 2023
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  19. The very-high-risk prostate cancer: a contemporary update.Prostate cancer and prostatic diseases · 2016
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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 3 institutions in 1 country.

Mark ThalgottDepartment of Urology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Str, 22, Munich 81675, Germany. mark.thalgott@lrz.tum.de.
Thomas Horn
Matthias M Heck
Tobias Maurer
Matthias Eiber
Margitta Retz
Michael Autenrieth
Kathleen Herkommer
Bernd J Krause
Jürgen E Gschwend
Uwe Treiber
Hubert R Kübler
Technical University of Munich · DEKlinikum rechts der Isar · DEUniversitätsmedizin Rostock · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with locally advanced and high-risk prostate cancer (LAPC) are prone to experience biochemical recurrence despite radical prostatectomy (RP). We evaluated feasibility, safety and activity of a neoadjuvant chemohormonal therapy (NCHT) with 3-weekly full dose docetaxel and complete androgen blockade (CAB) in locally advanced and high-risk prostate cancer patients (LAPC) undergoing RP.

methodsPatients (n = 30) were selected by Kattans' preoperative score and received trimestral buserelin 9,45 mg, bicalutamide 50 mg/day and 3 cycles docetaxel (75 mg/m²) followed by RP. Primary endpoints were biochemical (PSA) and local downstaging. Secondary endpoints included toxicity and operability assessments, pathological complete response (pCR), time to PSA progression, 5-year biochemical recurrence free survival (bRFS) and overall survival (OS).

resultsMedian baseline PSA was 25.8 ng/ml (2.1-293), and the predicted probability of 5-year bRFS was 10% (0-55). NCHT induced PSA-reduction was 97.3% (81.3-99.9%; p < 0.001) and post-RP 96.7% of patients were therapy responders, with undetectable PSA-values. Post- vs. pretreatment MRI indicated a median tumor volume reduction of 46.4% (-31.3-82.8; p < 0.001). A pathological downstaging was observed in 48.3%. Severe hematologic toxicities (≥CTC3) were frequent with 53.8% leucopenia, 90% neutropenia and 13.3% febrile neutropenia. RP was performed in all patients. While resectability was hindered in 26.7%, continence was achieved in 96.7%. Pathologic analyses revealed no pCR. Lymph node- and extracapsular involvement was observed in 36.7% and 56.7% with 33.3% positive surgical margins. After a median of 48.6 (19.9-87.8) months, 55.2% of therapy responders experienced PSA-recurrence. The estimated median time to PSA-progression was 38.6 months (95%CI 30.9-46.4) and 85.3 months (95%CI 39.3-131.3) for OS. The 5-year bRFS was improved to 40%, but limiting for interpretation adjuvant treatment was individualized.

conclusionsNCHT is feasible despite high hematotoxicity, with excellent functional results. Significant downstaging was observed without pCR. NCHT seems to improve the cohort adjusted 5-year bRFS, but clinical value needs further investigation in randomized trials.

Indexed as

AgedAndrogen AntagonistsDisease ProgressionDocetaxelHumansMaleMiddle AgedNeoadjuvant TherapyProstatic NeoplasmsSurvival AnalysisTaxoidsTreatment OutcomeAndrogen AntagonistsDocetaxelTaxoids

Identifiers

PMID24598155
PMCPMC3974001
OpenAlexW2133828863

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.