NCT01620515 is a Phase 2 clinical trial of NX-1207 2.5 mg in Prostate Cancer, sponsored by Nymox Corporation.

Who is sponsoring NCT01620515?

NCT01620515 is sponsored by Nymox Corporation.

What drugs are being tested in NCT01620515?

Interventions in NCT01620515: NX-1207 2.5 mg, NX-1207 15 mg.

What condition does NCT01620515 study?

NCT01620515 studies Prostate Cancer.

Is NCT01620515 still recruiting?

NCT01620515 is currently completed. Last updated 10 March 2017.

Last reviewed 2017-03-10 · How we verify

NCT01620515

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

Two-Dose Level Evaluation of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer

Completed Phase 2 Last updated 10 March 2017

What this trial tests

Phase 2 trial testing NX-1207 2.5 mg in Prostate Cancer in 141 participants. Completed in 21 October 2015.

Timeline

21 February 2012

Primary endpoint
21 October 2015

21 October 2015

Quick facts

Lead sponsor	Nymox Corporation
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	141
Start date	21 February 2012
Primary completion	21 October 2015
Estimated completion	21 October 2015
Sites	23 locations across United States

Drugs / interventions tested

NX-1207 2.5 mg — full drug profile →
NX-1207 15 mg — full drug profile →

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Nymox Corporation — full company profile →

Who can join

Adults 45 to 85, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is designed to evaluate the safety and efficacy of a single injection of NX-1207 for the treatment of biopsy-confirmed low risk localized (T1c) prostate cancer in patients currently undergoing active surveillance. Study participants currently on active surveillance will be randomized either to treatment with a single intraprostatic injection of NX-1207 (2.5 mg or 15 mg) followed by active surveillance or to no treatment (continued active surveillance). Blinded efficacy evaluation will be by a second post-treatment prostate biopsy.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Fexapotide triflutate: results of long-term safety and efficacy trials of a novel injectable therapy for symptomatic prostate enlargement.
Shore N, Tutrone R, Efros M, Bidair M, et al · · 2018 · cited 14× · PMID 29380128 · DOI 10.1007/s00345-018-2185-y
Efficacy and safety of fexapotide triflutate in outpatient medical treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia.
Shore N, Tutrone R, Roehrborn CG. · · 2019 · cited 3× · PMID 30719081 · DOI 10.1177/1756287218820807
Prospective evaluation of fexapotide triflutate injection treatment of Grade Group 1 prostate cancer: 4-year results.
Shore N, Kaplan SA, Tutrone R, Levin R, et al · · 2020 · cited 2× · PMID 32088746 · DOI 10.1007/s00345-020-03127-w

Verify or expand the search:

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

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 NCT01620515 (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 Nymox Corporation
Last refreshed: 10 March 2017

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/NCT01620515.

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