Evidence map›Paper›PMID 35430584›Full record

Trial reportProstate cancer and prostatic diseases2022

LHRH sparing therapy in patients with chemotherapy-naïve, mCRPC treated with abiraterone acetate plus prednisone: results of the randomized phase II SPARE trial.

Carsten-Henning Ohlmann, Michelle Jäschke, Peter Jaehnig, Susanne Krege, Jürgen Gschwend, Heidrun Rexer, Kerstin Junker, Roger Zillmann, Christoph Rüssel, Eva Hellmis and 11 more

Erratum issuedOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Prostate cancer and prostatic diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.0field-weighted citation impact, top 13% 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

6 citing papers in PubMed, 13 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. [Novel hormone treatment for advanced prostate cancer].Urologie (Heidelberg, Germany) · 2023
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 7 institutions in 1 country.

Carsten-Henning OhlmannDepartment of Urology, Saarland University Medical Center, Homburg/Saar, Germany. carsten-henning.ohlmann@bn.johanniter-kliniken.de.ORCID http://orcid.org/0000-0003-1562-5364
Michelle JäschkeDepartment of Urology, Saarland University Medical Center, Homburg/Saar, Germany.
Peter Jaehnigpj statistics, Berlin, Germany.
Susanne KregeDepartment of Urology, Evangelische Kliniken Essen Mitte, Essen, Germany.
Jürgen GschwendDepartment of Urology, Klinikum Rechts der Isar, Technical University Munich, Munich, Germany.
Heidrun RexerMeckevidence, Schwarz, Germany.
Kerstin JunkerDepartment of Urology, Saarland University Medical Center, Homburg/Saar, Germany.
Roger ZillmannUrologie Pankow, Berlin, Germany.
Christoph RüsselUrologie Borken, Borken, Germany.
Eva HellmisUrologicum-Duisburg Fachärztesozietät, Duisburg, Germany.
Henrik SuttmannUrologikum Hamburg MVW, Hamburg, Germany.
Martin JanssenDepartment of Urology, Saarland University Medical Center, Homburg/Saar, Germany.
Jan MarinUrologie Kempen, Münster, Germany.
Andreas HübnerZentrum für Onkologie und Urologie, Rostock, Germany.
Michael MathersPandamed, Remscheid, Germany.
Jochen GleißnerUro-Gyn-Praxis Am Wall, Wuppertal, Germany.
Michael SchefflerUrologische Gemeinschaftspraxis, Zwickau, Germany.
Susan FeyerabendStudienpraxis Urologie, Nürtingen, Germany.
Jens TelleUrologische Praxisgemeinschaft, Wolfsburg, Germany.
Jörg KlierUrologische Partnerschaft, Köln, Germany.
Michael StöckleDepartment of Urology, Saarland University Medical Center, Homburg/Saar, Germany.
Saarland University · DEDermatologikum Hamburg · DEDeutsche Gesellschaft für Urologie · DEJohanniter-Krankenhaus Bonn · DEKliniken Essen-Mitte · DEPark-Klinik Birkenwerder · DETUM Klinikum · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough the benefit of androgen deprivation therapy (ADT) continuation in metastatic castration-resistant prostate cancer (mCRPC) remains controversial, clinical evidence is lacking. Recent results indicated that treatment with abiraterone acetate (AA) plus prednisone (P) further suppresses serum testosterone levels over ADT alone, suggesting that continuation of ADT in the treatment of mCRPC may not be necessary.

methodsIn this exploratory phase 2 study, mCRPC patients were randomized with a 1:1 ratio to receive either continued ADT plus AA + P (Arm A) or AA + P alone (Arm B). The primary endpoint was the rate of radiographic progression-free survival (rPFS) at month 12. Secondary endpoints included PSA-response rate, objective response, time to PSA progression and safety.

resultsA total of 68 patients were equally randomized between the two study arms. Median testosterone-levels remained below castrate-levels throughout treatment in all patients. According to the intention-to-treat analysis the rPFS rate was 0.84 in Arm A and 0.89 in Arm B. Moderate and severe treatment-emergent adverse events were reported for 72% of the patients in Arm A and for 85% of the patients in Arm B.

conclusionsAA + P treatment without ADT may be effective in mCRPC patients and ADT may not be necessary in patients receiving AA + P.

Indexed as

Abiraterone AcetateProstatic Neoplasms, Castration-ResistantAndrogen AntagonistsAntineoplastic Combined Chemotherapy ProtocolsGonadotropin-Releasing HormoneHumansMalePrednisoneProstate-Specific AntigenTestosteroneTreatment OutcomeAbiraterone AcetateAndrogen AntagonistsGonadotropin-Releasing HormonePrednisoneProstate-Specific AntigenTestosterone

Identifiers

PMID35430584
PMCPMC9705242
OpenAlexW4223946478

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.