Evidence map›Paper›PMID 33800872›Full record

ArticleCancers2021

Salvage-Radiation Therapy and Regional Hyperthermia for Biochemically Recurrent Prostate Cancer after Radical Prostatectomy (Results of the Planned Interim Analysis).

Marcus Beck, Pirus Ghadjar, Felix Mehrhof, Daniel Zips, Frank Paulsen, Daniel Wegener, Susen Burock, David Kaul, Carmen Stromberger, Jacek Nadobny and 6 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Cancers, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04159051 (Phase II Studie Zur Hyperthermen Salvage-Radiotherapie Bei Prostatakarzinompatienten Mit Biochemischem Rezidiv Nach Prostatektomie), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.6field-weighted citation impact, top 38% 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.

NCT04159051 naunknown statusnot on this map

Phase II Studie Zur Hyperthermen Salvage-Radiotherapie Bei Prostatakarzinompatienten Mit Biochemischem Rezidiv Nach Prostatektomie

TypeinterventionalSponsorCharite University, Berlin, GermanyRan2016 to 2024Enrolled100ConditionsProstate Cancer, RecurrenceArmsRegional Hyperthermia
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 12 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. A patterns of care analysis of hyperthermia in combination with radio(chemo)therapy or chemotherapy in European clinical centers.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2023
    Article
  5. Article
  6. Article
  7. Article
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

16 authors at 4 institutions in 1 country.

Marcus BeckCharité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Radiation Oncology, 13353 Berlin, Germany.ORCID 0000-0003-1940-2571
Pirus GhadjarCharité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Radiation Oncology, 13353 Berlin, Germany.
Felix MehrhofCharité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Radiation Oncology, 13353 Berlin, Germany.ORCID 0000-0003-0553-4290
Daniel ZipsDepartment of Radiation Oncology, University Hospital Eberhard-Karls-University Tübingen, 72076 Tübingen, Germany.
Frank PaulsenDepartment of Radiation Oncology, University Hospital Eberhard-Karls-University Tübingen, 72076 Tübingen, Germany.ORCID 0000-0001-8836-528X
Daniel WegenerDepartment of Radiation Oncology, University Hospital Eberhard-Karls-University Tübingen, 72076 Tübingen, Germany.
Susen BurockCharité Comprehensive Cancer Center, Charité Universitätsmedizin Berlin, 10117 Berlin, Germany.
David KaulCharité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Radiation Oncology, 13353 Berlin, Germany.ORCID 0000-0002-7906-5629
Carmen StrombergerCharité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Radiation Oncology, 13353 Berlin, Germany.
Jacek NadobnyCharité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Radiation Oncology, 13353 Berlin, Germany.
Oliver J OttDepartment of Radiation Oncology, Universitätsklinikum Erlangen, 91054 Erlangen, Germany.ORCID 0000-0001-5806-6158
Rainer FietkauDepartment of Radiation Oncology, Universitätsklinikum Erlangen, 91054 Erlangen, Germany.
Volker BudachCharité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Radiation Oncology, 13353 Berlin, Germany.
Peter WustCharité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Radiation Oncology, 13353 Berlin, Germany.
Arndt-Christian MüllerDepartment of Radiation Oncology, University Hospital Eberhard-Karls-University Tübingen, 72076 Tübingen, Germany.
Sebastian ZschaeckCharité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Radiation Oncology, 13353 Berlin, Germany.
Humboldt-Universität zu Berlin · DEUniversity of Tübingen · DEUniversitätsklinikum Erlangen · DECharité - Universitätsmedizin Berlin · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Efforts to improve the outcome of prostate cancer (PC) patients after radical prostatectomy (RP) include adjuvant or salvage radiation therapy (SRT), but still up to 50% of patients develop a disease progression after radiotherapy (RT). Regional hyperthermia (HT) is well-known to improve tumor sensitivity to RT in several entities. Here we report on a planned interim analysis of tolerability and feasibility after recruitment of the first 50 patients of a trial combining SRT and HT. We conducted a prospective multicenter non-randomized Phase-II-Trial (HTProstate-NCT04159051) investigating the implementation of combined moderate-dose escalated SRT (70 Gy in 35 fractions) and locoregional deep HT (7-10 HT sessions). The primary endpoints were the rate of acute genitourinary (GU), gastrointestinal (GI), and HT-related toxicities, completed HT sessions (≥7), and SRT applications per protocol (≥95% of patients). The two-step design included a planned interim analysis for acute GU-, GI- and HT-specific toxicities to ensure patients' safety. Between November 2016 and December 2019, 52 patients entered into the trial. After 50 patients completed therapy and three months of follow-up, we performed the planned interim analysis. 10% of patients developed acute grade 2 GU and 4% grade 2 GI toxicities. No grade ≥3 GU or GI toxicities occurred. HT-specific symptoms grade 2 and 3 were observed in 4% and 2% of all patients. Thus, the pre-specified criteria for safety and continuation of recruitment were met. Moreover, ≥7 HT treatments were applicable, indicating the combination of SRT + HT to be feasible. Evaluation of early QoL showed no significant changes. With its observed low rate of GU and GI toxicities, moderate and manageable rates of HT-specific symptoms, and good feasibility, the combined SRT + HT seems to be a promising treatment approach for biochemical recurrence after RP in PC patients.

Indexed as

dose-escalationhyperthermiapostoperativeprostate cancerradiosensitizationsalvage radiation therapy

Identifiers

PMID33800872
PMCPMC7961934
OpenAlexW3134562638

What OpenQuestion holds

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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.