Loading search results
OSTRICh
A Randomized, Open Label, Phase IIB Trial of Optimal Sequencing of Treatment Options for Poor Risk Metastasized Castration Resistant Prostate Cancer Previously Treated With Docetaxel
Sponsor study identifier
interventional
100
1 country
19
Study Start
May 7, 2017
Actual (reported)Primary Completion
December 16, 2020
Actual (reported)Study Completion
March 2, 2022
Actual (reported)Rationale: The aim of this study is to identify the optimal second line treatment option for patients with a poor prognosis metastasized Castration Resistant Prostate Cancer (mCRPC) with respect to Clinical Benefit Rate (CBR) rate and quality of life. Objective: The primary endpoint is CBR in mCRPC patients with poor prognostic features and previously treated with docetaxel, randomized between cabazitaxel (Arm A) and novel hormonal agents (abiraterone OR enzalutamide) as second-line therapy (Arm B). Intervention: Patients in Arm A will receive cabazitaxel and prednisone and patients in Arm B will receive abiraterone and prednisone OR enzalutamide. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Treatment regimens evaluated in this trial are used in common mCRPC treatment practice and are reimbursed. Risk of side effects or death as a result of treatment is not affected by the trial design. At baseline, prior to each treatment cycle and at end of treatment, patients are requested to visit the out-patient clinic, where a physical exam will be performed in combination with vena puncture for blood analysis. Radiological evaluation will be performed at base line, after 3 months of treatment and at end of treatment. All above mentioned interventions can be considered as standard practice. Patients are requested to fill out QoL and pain/analgesic use questionnaires at base line, prior to each cycle and at end of treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 7, 2017
Actual (reported)July 17, 2017
Actual (reported)September 28, 2017
Actual (reported)December 16, 2020
Actual (reported)March 2, 2022
Actual (reported)Clinical benefit rate
• To assess the Clinical Benefit Rate (CBR) in patients with mCRPC and poor prognostic factors treated with cabazitaxel (Arm A) or novel hormonal agents (abiraterone OR enzalutamide) as second-line therapy (Arm B) who have been treated with docetaxel.
From start treatment until 12 weeks of treatment
Comparing clinical benefit rate in arm A and arm B
From start treatment until 12 weeks of treatment
Duration of treatment
for each patient; until end of treatment (for Arm A max 30 weeks, for Arm B max 24 months)
Progression free survival
for each patient; until progression or through study completion (max 24 months)
Overall survival
for each patient; until death or end of trial (max 24 months)
(serious) adverse events according to the ctcae v4.03: number of incidents, number of participants with (S)AE's
for each patient: until 28 days after the last treatment
Exploratory objectives; neutrophil to lymphocyte ratio
For each patient: until the end of treatment, Arm A max 30 weeks, Arm B max 24 months
Exploratory objectives; number of mutations in 73 genes from cell-free DNA
For each patient: until the end of treatment, Arm A max 30 weeks, Arm B max 24 months
Exploratory objectives; epigenetics-based biomarker discovery using cfDNA
For each patient: until end of treatment (max 24 months)
Cabazitaxel 25mg/m2 IV, once every 3 weeks
At physician's discretion: Abiraterone 1000mg oral, taken daily Prednisone 5mg oral, 2 times a day OR Enzalutamide 160mg oral taken daily
Cabazitaxel 25mg/m2 IV, once every 3 weeks
Abiraterone 1000mg oral, taken daily + Prednisone 5mg oral, 2 times a day
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Bovenij ziekenhuis
Amsterdam, Netherlands
Rode Kruis Ziekenhuis
Beverwijk, 1940 EB, Netherlands
Tergooi Ziekenhuizen
Blaricum, Netherlands
Deventer Ziekenhuis
Deventer, Netherlands
Slngeland Ziekenhuis
Doetinchem, Netherlands
Ziekenhuisgroep Twente
Hengelo, Netherlands
100 participants (actual enrollment reported by the registry).
First Submitted
July 17, 2017
First Posted
September 28, 2017
Study Start
May 7, 2017
Actual (reported)Enzalutamide 160mg oral taken daily
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Spaarne Ziekenhuis
Hoofddorp, Netherlands
Dijklander ziekenhuis
Hoorn, Netherlands
Medisch Centrum leeuwarden
Leeuwarden, Netherlands
Academisch medisch centrum Maastricht
Maastricht, Netherlands
Sint Antonius ziekenhuis
Nieuwegein, Netherlands
Franciscus Gasthuis-Vlietland
Rotterdam, Netherlands
Zorgsaam Ziekenhuis
Terneuzen, Netherlands
Haga Ziekenhuis
The Hague, Netherlands
Diakonessenhuis
Utrecht, Netherlands
Universitair medisch centrum Utrecht
Utrecht, Netherlands
Viecuri medisch centrum Noord-Limburg
Venlo, Netherlands
Isala Klinieken
Zwolle, Netherlands
Primary Completion
December 16, 2020
Actual (reported)Study Completion
March 2, 2022
Actual (reported)Last Updated
April 15, 2022
Record last verified: 2022-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: