NCT04655365 (PROSTEP-002) is a Phase 2 clinical trial of Enzalutamide capsule in Prostate Cancer, sponsored by CHU de Quebec-Universite Laval.

Who is sponsoring NCT04655365?

NCT04655365 is sponsored by CHU de Quebec-Universite Laval.

What drugs are being tested in NCT04655365?

Interventions in NCT04655365: Enzalutamide capsule.

What condition does NCT04655365 study?

NCT04655365 studies Prostate Cancer.

Is NCT04655365 still recruiting?

NCT04655365 is currently active, enrolled. Last updated 23 December 2025.

Last reviewed 2025-12-23 · How we verify

NCT04655365: PROSTEP-002

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Detecting Metastases by PyL PET/CT in Subjects Starting Enzalutamide for Untreated Castration Resistant Prostate Cancer.

Active, enrolled Phase 2 Last updated 23 December 2025

What this trial tests

Phase 2 trial testing Enzalutamide capsule in Prostate Cancer in 50 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

22 March 2022

Primary endpoint
1 November 2025

1 September 2026

Quick facts

Lead sponsor	CHU de Quebec-Universite Laval
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	22 March 2022
Primary completion	1 November 2025
Estimated completion	1 September 2026
Sites	4 locations across Canada

Drugs / interventions tested

Enzalutamide capsule — full drug profile →

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

CHU de Quebec-Universite Laval — full company profile →

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aimed to evaluate the diagnostic performance of 18F-DCFPyL (PyL) PET/CT in subjects presenting not previously treated for castration resistant prostate cancer and showing negative or equivocal findings per institutional standard of care conventional imaging

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Analysis of Clinical Trials and Review of Recent Advances in Therapy Decisions for Locally Advanced Prostate Cancer.
Williams NR. · · 2023 · cited 1× · PMID 37373928 · DOI 10.3390/jpm13060938

Verify or expand the search:

Other trials of Enzalutamide capsule

Trials testing the same drug.

NCT06582628 — Talazoparib Plus Enzalutamide After Progression to Abiraterone in Metastatic Prostate Cancer: (TEAM PC) · Phase 2 · recruiting

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno) · recruiting
NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting

Other CHU de Quebec-Universite Laval trials

Trials by the same sponsor.

NCT07067827 — Self-questionnaire in Osteoporosis · recruiting
NCT06018116 — A Canadian Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer. · Phase 2 · withdrawn
NCT05941806 — Prophylactic Use of Tamsulosin in the Prevention of Post-operative Urinary Retention in Men After Rectum Resection · Phase 3 · unknown
NCT06351176 — Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes · enrolling by invitation
NCT05859139 — Scaling a Decision Aid on Prenatal Screening for Trisomy 21, 18 and 13 · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04655365 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by CHU de Quebec-Universite Laval
Last refreshed: 23 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04655365.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing