Evidence map›Paper›PMID 34698353›Full record

Trial reportJapanese journal of clinical oncology2022

A randomized controlled trial evaluating the effect of low-dose chlormadinone in patients with low-risk prostate cancer: PROSAS study.

Mikio Sugimoto, Yoshiyuki Kakehi, Shigeo Horie, Yoshihiko Hirao, Hideyuki Akaza

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Japanese journal of clinical oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 30% 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

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Observational
  2. Review
  3. Article
  4. Observational
  5. Review
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

5 authors at 4 institutions in 1 country.

Mikio SugimotoDepartment of Urology, Kagawa University Faculty of Medicine, Kagawa, Japan.ORCID 0000-0001-9266-782X
Yoshiyuki KakehiKagawa University, Kagawa, Japan.
Shigeo HorieDepartment of Urology, Juntendo University Faculty of Medicin, Tokyo, Japan.
Yoshihiko HiraoOsaka Gyoumeikan Hospital, Osaka, Japan.
Hideyuki AkazaInterfaculty Initiative in Information Studies, Graduate School of Interdisciplinary Information Studies, The University of Tokyo, Tokyo, Japan.
Kagawa University · JPJuntendo University · JPOsaka Ekisaikai Hospital · JPTokyo University of Information Sciences · JP

Funding

ASKA Pharmaceutical Company Limited
6 · The paper itself

Abstract

objectivesThis study was conducted to evaluate the effect of low-dose chlormadinone acetate, an antiandrogen agent, on the persistence rate of active surveillance in patients with low-risk prostate cancer.

methodsThe study was a multicenter, placebo-controlled, double-blind, randomized controlled trial conducted at 38 sites in Japan. Low-risk prostate cancer patients were randomly assigned to the chlormadinone group or the placebo group and the persistence rate of active surveillance was evaluated for 3 years.

resultsSeventy-one patients in the chlormadinone group and 72 patients in the placebo group were analyzed. The persistence rate of active surveillance [95% CI] at 3 years was 75.5% [62.5-84.6] in the chlormadinone group and 50.1% [36.7-62.2] in the placebo group, showing a significant difference between the groups (P = 0.0039). The hazard ratio [95% CI] of the chlormadinone group to the placebo group for discontinuation of active surveillance was 0.417 [0.226-0.770]. The chlormadinone group showed a significant decrease in prostate specific antigen level, testosterone level and prostate volume. The number of positive cores at 12 and 36 months biopsy was significantly lower in the chlormadinone group. The incidence of adverse events was 43.7% in the chlormadinone group and 12.5% in the placebo group. The most common adverse event in the chlormadinone group was constipation in 22.5%, followed by hepatobiliary disorders in 9.9%.

conclusionsIn patients with low-risk prostate cancer, low-dose chlormadinone showed a reduced number of positive cores and prostate volume, and an increased persistence rate of active surveillance (UMIN000012284).

Indexed as

Chlormadinone AcetateProstatic NeoplasmsAndrogen AntagonistsDouble-Blind MethodHumansJapanMaleAndrogen AntagonistsChlormadinone Acetateactive surveillancechlormadinone acetatepersistence rateprostate cancerQOL

Identifiers

PMID34698353
PMCPMC8825478
OpenAlexW3208545549

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Registered trials

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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.