PRIMORDIUM

An aspect marked incomplete is a question the public commentary did not let us answer. We show it rather than hide it.

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Jun 10, 2021 → Aug 24, 2026

Cited window

Jun 10, 2021 → Aug 24, 2026

Retrieved

Oct 31, 2026

Title

A Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer, Assessed by PSMA-PET With an Observational Cohort

Registry

NCT04557059

Study IDs

CR108705 · 56021927PCR3015 (Janssen Research & Development, LLC) · 2019-002957-46 · 2023-505852-23-00 (EUCT number)

Sponsor

Janssen Pharmaceutica N.V., Belgium

Design

Phase 3 · Interventional, randomized, parallel

Status

Active, not recruiting

Enrollment

691 actual

Registered

2020-09-21

Start

2020-11-12 actual

Primary completion

2029-08-27 estimated

Primary endpoint

Prostate specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Metastatic Progression-free Survival (ppMPFS)

Interventions

3 registered

This report does not judge efficacy, estimate HCP prevalence or consensus or give treatment advice.

• –Discussion that does not name the trial may be missing from this edition.
• –Not yet captured in this edition: a view on molecular subtype selection for adding hormonal therapy to salvage radiotherapy in recurrent prostate cancer.
• –Not yet captured in this edition: a view on unequal access to PSMA PET for initial staging versus monitoring.
• –Not yet captured in this edition: a view on how postoperative disease status qualifies adjuvant-versus-salvage radiotherapy comparisons.
• –Not yet captured in this edition: a view on age, chemotherapy fitness and PSA kinetics when selecting patients for treatment intensification.
• –Not yet captured in this edition: a view on community referral networks and regional limitations in access to multidisciplinary specialty care.
• –Not yet captured in this edition: a question about omitting ADT during early salvage radiotherapy and using genomic assays to guide selection.
• –Not yet captured in this edition: a question about counseling patients on localized prostate cancer and local treatment choices.
• –Not yet captured in this edition: a view on adopting recurrence-reducing treatment approaches conditional on positive study evidence.
• –Not yet captured in this edition: a view on androgen-receptor–targeted treatment intensification in biochemical recurrence.
• –Not yet captured in this edition: a view on uncertainty in imaging-defined disease status when choosing systemic or metastasis-directed treatment.
• –Not yet captured in this edition: a view on uncertain benefit from treatment intensification, pelvic-radiation subgroup interpretation, and incomplete publication in high-risk localized disease.
• –Not yet captured in this edition: a question about whether continuous versus intermittent androgen deprivation and androgen-receptor inhibition changes benefits in high-risk hormone-sensitive prostate cancer.
• –Some passages in the sources used in this report were not fully assessed for clinician views, so a view there may be missing from this edition.
• –455 statements in the sources reviewed for this edition are about other patients or topics, or only mention the trial, and are not counted.
• –Further source limits: discussion that describes the trial without naming it may be incomplete; some discussion that describes the trial without naming it may be missing; sources about other trials are not included.
• –The sources reviewed for this edition do not include an available protocol or an exact-trial results publication; favorable reactions cannot establish PRIMORDIUM efficacy or safety.
• –Commentators give differing accounts of treatment duration and prior local treatment. These differences are preserved rather than resolved from incomplete documentation.
• –Discussion coverage is incomplete. Trial-name searches can miss unnamed references, and some relevant sections of longer programs were not fully assessed. The report therefore cannot fully characterize every treatment preference, reason for deferral, stopping strategy or comparative-endpoint interpretation expressed in those programs; absence here does not establish absence of dissent.
• –Podcast and video versions contain overlapping a speaker–another speaker material; their repetition is not additional independent HCP evidence.
• –Unknown speakers may be named participants in the same program and are not counted as separate people or placed in opposition to identified speakers from that program.
• –Other-study efficacy accounts, biological mechanisms, assay-approval statements and future implementation forecasts are attributed views, not independently adjudicated conclusions.
• –Some speakers' identities or clinical roles are not established in the sources used in this report; each statement is attributed only as far as its source shows.
• –Drug-label information available for this edition does not establish authorization for the particular trial combination.
• –Publication and post dates identify the source timing, not necessarily the date of the underlying session or a study readout; they do not establish changes of mind.

How reports are built and checked: Methods.

Last checked for new commentary Oct 31, 2026. A new or changed finding gets a new version number; added evidence alone is a smaller update. No corrections.

Paste this into ChatGPT, Claude, Microsoft Copilot or your own agent. It previews this report through the free Erudio MCP server, tells you whether it answers your question, and orders it if you ask. Some agents ask you to confirm pasted instructions before acting; that is expected.

Help me decide whether to buy the Erudio report "PRIMORDIUM" (NCT04557059), and buy it for me if I ask. Erudio reports cover what clinicians say in public about one clinical trial, with every verified statement linked to its source.

1. Use the free Erudio MCP server at https://mcp.erudio.com/free; it needs no sign-in. Nothing needs installing: if it is not connected in this app and you can make HTTP requests, call it directly with JSON-RPC POSTs to that URL (initialize, then tools/call), sending "Accept: application/json, text/event-stream". Call get_report_card with slug "primordium-04557059". If you cannot make requests, read https://www.erudio.com/reports/primordium-nct04557059.md instead.
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4. Once it is paid, call get_order with the status_url: it returns my license key. Then use the Erudio MCP server at https://mcp.erudio.com/mcp with the header "Authorization: Bearer <key>". Call read_report with report_id erudio-nct04557059 and sections ["all"], and summarize the findings for me with their sources. The full report is large (about 500 KB): save the response to a file and work from it rather than printing it. If you cannot, read sections ["narratives"] first, the executive summary and analysis.

When you tell me what clinicians said, give each view as theirs, with its source. Counts are the sources the report kept, not the share of clinicians who agree. Reports are not medical advice.
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curl https://www.erudio.com/reports/primordium-nct04557059.json
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# MCP, no sign-in (https://mcp.erudio.com/free)
get_report_card({ "slug": "primordium-04557059" })