NCT01558219 (ProstyII) is a Phase 2 clinical trial of cabacitaxel in Metastatic Prostate Cancer, sponsored by Tampere University Hospital.

Who is sponsoring NCT01558219?

NCT01558219 is sponsored by Tampere University Hospital.

What drugs are being tested in NCT01558219?

Interventions in NCT01558219: cabacitaxel.

What condition does NCT01558219 study?

NCT01558219 studies Metastatic Prostate Cancer.

Is NCT01558219 still recruiting?

NCT01558219 is currently completed. Last updated 20 October 2016.

Last reviewed 2016-10-20 · How we verify

NCT01558219: ProstyII

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

Open, Single-arm, Multicenter, Phase II Trial Investigating the Safety of Biweekly Cabazitaxel in Metastatic Castration Resistant Prostate Cancer Patients Previously Treated With a Docetaxel-containing Regimen

Completed Phase 2 Last updated 20 October 2016

What this trial tests

Phase 2 trial testing cabacitaxel in Metastatic Prostate Cancer in 60 participants. Completed in 1 December 2014.

Timeline

1 November 2011

Primary endpoint
1 December 2014

1 December 2014

Quick facts

Lead sponsor	Tampere University Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 November 2011
Primary completion	1 December 2014
Estimated completion	1 December 2014
Sites	1 location across Finland

Drugs / interventions tested

cabacitaxel — full drug profile →

Conditions studied

Metastatic Prostate Cancer — all drugs for Metastatic Prostate Cancer →

Sponsor

Tampere University Hospital

Who can join

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

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Safety and tolerabilty
Time frame: every 2 weeks
NCI CTC-AE version 4 Adverse events in every organ systems and laborotory values (Grades from 0 to 5, 0=no adverse events, 5= dead)from baseline up to the end of the treatment

Sponsor's own description

This study is designed to evaluate the safety of biweekly cabazitaxel for the treatment of metastatic castration resistant prostate cancer (mCRPC) patients previously treated with docetaxel containing regimen. The primary endpoint is safety. Secondary endpoints include time to treatment failure, response rate, overall survival and quality of life.

Publications & conference data

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

The role of cabazitaxel in the treatment of metastatic castration-resistant prostate cancer.
Tsao CK, Cutting E, Martin J, Oh WK. · · 2014 · cited 36× · PMID 24883107 · DOI 10.1177/1756287214528557
Cabazitaxel in the treatment of metastatic castration-resistant prostate cancer: patient selection and special considerations.
Patel SA, Hoffman-Censits J. · · 2017 · cited 4× · PMID 28860817 · DOI 10.2147/ott.s103532

Verify or expand the search:

Other recruiting trials for Metastatic Prostate Cancer

Currently open trials in the same condition.

NCT07145177 — 177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer · Phase 1 · recruiting
NCT07290270 — Real-world Use of Lutetium (177Lu) Vipivotide Tetraxetan in China(PSMAreal CN) · recruiting
NCT07389512 — Pharmaceutical Management in Targeted Radioligand Therapy · recruiting
NCT07209176 — Physician- and Patient-based Barriers to NGS Testing · NA · recruiting
NCT07181161 — Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer · Phase 1, PHASE2 · recruiting

Other Tampere University Hospital trials

Trials by the same sponsor.

NCT07315568 — Couples and Microbial Diversity · not yet recruiting
NCT07128992 — Need-driven Treatment of the Patients With Type 1 Diabetes · not yet recruiting
NCT07042139 — No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older · NA · recruiting
NCT07528833 — Health Effects of Mindfulness Based Stress Reduction Course in Treatment of Back Pain · NA · recruiting
NCT06711796 — Measurement of Muscle Relaxation of the Hand in From Two Muscles and Two Hand Positions · 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 NCT01558219 (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 Tampere University Hospital
Last refreshed: 20 October 2016

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/NCT01558219.

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