Clinical trial · Interventional
A Study of Alpharadin With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer (CRPC)
A Phase I/IIa Study of Safety and Efficacy of Alpharadin® With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer
NCT01106352CI-TRIAL-00025333completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this study is to establish a recommended dose of Alpharadin to be used in combination with docetaxel in patients with bone metastases from castration-resistant prostate cancer and to investigate safety and explore efficacy of the recommended dose.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases | — | UNRESOLVED | — |
| Castration-Resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Radium-223 dichloride (Xofigo, BAY88-8223) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radium-223 dichloride (Xofigo, BAY88-8223) + docetaxel
- description
- Alpharadin (Radium-223 dichloride) is administered intravenously as a bolus injection. In the randomized phase IIa part of the protocol, the dose established in the dose-escalation part of the protocol (Phase I) will be used, i.e. 5 doses of 50 kBq/kg b.w. every 6 weeks in combination with the approved step-down dose of docetaxel (60 mg/m\^2) administered intravenously every 3 weeks with 5 mg prednisone twice a day continuously and pre-medication with dexamethasone.
- interventionNames
- Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
- Drug: Docetaxel
- type
- ACTIVE_COMPARATOR
- label
- Docetaxel
- description
- Docetaxel (75 mg/m2) will be administered intravenously every 3 weeks with 5 mg prednisone twice a day continuously and pre-medication with dexamethasone. Step-down to 60 mg/m\^2 is allowed as per the approved docetaxel label.
- interventionNames
- Drug: Docetaxel
Primary outcomes (14)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate. * Two or more bone metastases (hot spots) confirmed by bone scintigraphy within 8 weeks prior to study entry * Known castration-resistant disease * Karnofsky Performance Status (KPS): ≥70% within 14 days before start of study treatment (ECOG 1) * Life expectancy at least 6 months. * Acceptable hematology and serum biochemistry screening values * Eligible for use of docetaxel according to the product information (package insert or similar). Exclusion Criteria: * Has received an investigational therapeutic drug within the last 4 weeks prior to start of study treatment, or is scheduled to receive one during the treatment period. * Has received external radiotherapy within the last 4 weeks prior to start of study treatment. * Has an immediate need for radiotherapy. * Has received prior hemibody external radiotherapy . * Has received systemic radiotherapy (e.g. samarium, strontium etc.) for the treatment of bone metastases. * Has received cytotoxic chemotherapy within the last 4 weeks prior to start of study treatment, or has not recovered to grade 1 or 0 from adverse events due to cytotoxic chemotherapy administered more than 4 weeks earlier. * Has received more than ten previous infusions of docetaxel. * Previous known experience of grade ≥ 3 docetaxel related toxicities or docetaxel toxicity related dose interruption or discontinuation. * Previous use of G-CSF for persistent neutropenia after docetaxel treatment. * Has received blood transfusion or erythropoietin (EPO) within the last 4 weeks prior to start of study treatment. * Has received prior treatment with Alpharadin. * Malignant lymphadenopathy exceeding 3 cm in short-axis diameter. * Symptomatic nodal disease, i.e. scrotal, penile or leg edema. * Visceral metastases from CRPC (\>2 lung and/or liver metastases \[size ≥2cm\]), as assessed by CT scan or MRI of the chest/abdomen/pelvis within the last 8 weeks prior to start of study treatment. * Uncontrolled loco-regional disease. * Other primary tumor (other than CRPC) including haematological malignancy present within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer). * Has imminent or established spinal cord compression based on clinical findings and/or MRI. * Unmanageable fecal incontinence
References
Publications (2)
- DERIVEDMorris MJ, Loriot Y, Sweeney CJ, Fizazi K, Ryan CJ, Shevrin DH, Antonarakis ES, Pandit-Taskar N, Deandreis D, Jacene HA, Vesselle H, Petrenciuc O, Lu C, Carrasquillo JA, Higano CS. Radium-223 in combination with docetaxel in patients with castration-resistant prostate cancer and bone metastases: a phase 1 dose escalation/randomised phase 2a trial. Eur J Cancer. 2019 Jun;114:107-116. doi: 10.1016/j.ejca.2019.04.007. Epub 2019 May 11. PMID 31082669
- DERIVEDGkialas IK, Fragkoulis C. Emerging therapies targeting castration-resistant prostate cancer. J BUON. 2015 Nov-Dec;20(6):1389-96. PMID 26854432