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NCT03295565: OSTRICh
Optimal Sequencing of Treatment Options for Poor Risk mCRPC Previously Treated With Docetaxel
Phase 2, PHASE3 trial testing Cabazitaxel in Prostate Cancer Metastatic in 100 participants. Completed in 2 March 2022.
16 December 2020
Quick facts
| Lead sponsor | The Netherlands Cancer Institute |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 7 May 2017 |
| Primary completion | 16 December 2020 |
| Estimated completion | 2 March 2022 |
| Sites | 19 locations across Netherlands |
Drugs / interventions tested
- Cabazitaxel (cabazitaxel) — full drug profile →
- Abiraterone (ABIRATERONE) — full drug profile →
- Enzalutamide (enzalutamide) — full drug profile →
Conditions studied
- Prostate Cancer Metastatic — all drugs for Prostate Cancer Metastatic →
- Metastasis — all drugs for Metastasis →
Sponsor
The Netherlands Cancer Institute
Who can join
18 and older, male only, with Prostate Cancer Metastatic or Metastasis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03295565
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cabazitaxel
Trials testing the same drug.
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- NCT06691984 — Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressiv · Phase 3 · recruiting
- NCT06353386 — Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Particip · Phase 1, PHASE2 · recruiting
- NCT06085729 — Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Var · Phase 1, PHASE2 · recruiting
Other recruiting trials for Prostate Cancer Metastatic
Currently open trials in the same condition.
- NCT07292168 — A Phase 1b/2 Study of the Safety and Efficacy of the Monoclonal Antibody OM-RCA-01 in Patients With Metastatic Tumors Ex · Phase 1, PHASE2 · recruiting
- NCT06165302 — Exercise in Prostate Cancer · NA · recruiting
- NCT07484971 — Study of the Epidemiological, Clinical, Diagnostic, and Therapeutic Characteristics of Prostate Cancers in Algeria · recruiting
- NCT06972628 — Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617 · Phase 2 · recruiting
- NCT07089550 — PSMA PET for Treatment Response evaLuation of systemIC Therapies in prostAte caNcer (PELICAN) · recruiting
Other The Netherlands Cancer Institute trials
Trials by the same sponsor.
- NCT07436858 — Whole Body HER2 Quantification With 89Zr-Trastuzumab PET/CT to Asses Zr-trastuzumab Accumulation in HER2-mutated and HER · Phase 1 · not yet recruiting
- NCT07071727 — Short Course of Radiotherapy Prior to Surgery of Soft Tissue Sarcomas · NA · recruiting
- NCT06931769 — TAO-Towards Optimal (Neo)Adjuvant Systemic Therapy of Stage III Triple-negative Breast Cancer · recruiting
- NCT06273800 — Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients · NA · recruiting
- NCT07310758 — Contrast-enhanced Ultrasound for Sentinel Node Detection · 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)
- Trial protocol + status: ClinicalTrials.gov NCT03295565 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Netherlands Cancer Institute
- Last refreshed: 15 April 2022
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/NCT03295565.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing