Evidence map›Paper›PMID 36472728›Full record

ArticleTargeted oncology2023

Coadministration of Apalutamide and Relugolix in Patients with Localized Prostate Cancer at High Risk for Metastases.

Gordon Brown, Laurence Belkoff, Jason M Hafron, Daniel R Saltzstein, Rushikesh Potdar, Amitabha Bhaumik, Jennifer Phillips, Tracy McGowan, Neal D Shore

Registry-linked trialOpen access · hybridAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Targeted oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04523207 (A Multi-center, Open-label, Single-arm Phase 2 Study of the Adjuvant Treatment of Apalutamide and Androgen Deprivation Therapy), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.8field-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.

NCT04523207 phase2completednot on this map

A Multi-center, Open-label, Single-arm Phase 2 Study of the Adjuvant Treatment of Apalutamide and Androgen Deprivation Therapy (ADT) in Treatment-naïve Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases

TypeinterventionalSponsorJanssen Research & Development, LLCRan2020 to 2023Enrolled108ConditionsProstatic NeoplasmsArmsApalutamide, ADT, Relugolix
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 12 citations in OpenAlex.

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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

9 authors at 6 institutions in 1 country.

Gordon BrownNew Jersey Urology, A Summit Health Company, 136 Route 73 N, Suites A&B, Voorhees, NJ, 08043, USA. gbrown@njurology.com.ORCID 0000-0001-8362-7068
Laurence BelkoffMidLantic Urology LLC, Bala Cynwyd, PA, USA.
Jason M HafronMichigan Institute of Urology, West Bloomfield, MI, USA.
Daniel R SaltzsteinUrology San Antonio, San Antonio, TX, USA.
Rushikesh PotdarJanssen Medical Affairs, Horsham, PA, USA.
Amitabha BhaumikJanssen Research and Development, Titusville, NJ, USA.
Jennifer PhillipsJanssen Medical Affairs, Horsham, PA, USA.
Tracy McGowanJanssen Medical Affairs, Horsham, PA, USA.
Neal D ShoreCarolina Urologic Research Center, Myrtle Beach, SC, USA.
Janssen (United States) · USAlliance for Decision Education · USCarolina Urologic Research Center · USMichigan Institute of Urology · USNew Jersey Urology · USUrology San Antonio · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe single-arm, open-label, multicenter, phase II Apa-RP study evaluates the biochemical recurrence (confirmed prostate-specific antigen [PSA] > 0.2 ng/mL)-free rate in patients with high-risk localized prostate cancer (HR-LPC) after radical prostatectomy following adjuvant apalutamide and androgen-deprivation therapy. In this substudy, relugolix, an oral gonadotropin-releasing hormone antagonist, was evaluated in combination with apalutamide.

objectiveThe aim of this study was to evaluate whether the approved standard maintenance dose of relugolix in combination with apalutamide sustains castrate testosterone levels (< 50 ng/dL). PATIENTS AND

methodsTwelve patients with HR-LPC who met all the main study criteria were included in the substudy. Patients received relugolix monotherapy for 2 weeks (loading dose [360 mg] at Day - 14 then 120 mg/day daily until Day - 1), then daily relugolix (120 mg) with apalutamide (240 mg) from Day 1 to Day 28. Endpoints were rate of maintained castration (testosterone < 50 ng/dL) through Day 28 (primary) and safety (secondary).

resultsAll 12 patients received relugolix and apalutamide and achieved castrate testosterone levels after 2-week relugolix monotherapy (median testosterone 348.5 ng/dL and 8.7 ng/dL at Days - 14 and - 1). All 11 patients who had testosterone measured at Day 28 maintained castrate testosterone (median 10.0 ng/dL) without relugolix dose adjustment. Treatment-emergent adverse events (TEAEs) occurred in nine patients during relugolix monotherapy and in eight patients during relugolix + apalutamide coadministration. Hot flush was the most common TEAE reported, in six and four patients, respectively.

conclusionsRelugolix administered at approved standard doses concurrently with apalutamide was effective in maintaining castrate testosterone levels in HR-LPC without new safety signals. TRIAL REGISTRATION NUMBER AND DATE: NCT04523207, 21 August 2020.

Indexed as

Prostatic NeoplasmsAndrogen AntagonistsHumansMalePhenylurea CompoundsPyrimidinonesTestosteroneThiohydantoinsAndrogen AntagonistsapalutamidePhenylurea CompoundsPyrimidinonesrelugolixTestosteroneThiohydantoins

Identifiers

PMID36472728
PMCPMC9928932
OpenAlexW4310784126

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.