Clinical trial · Interventional
Prostate Cancer Intensive, Non-Cross Reactive Therapy (PRINT) for Castration Resistant Prostate Cancer (CRPC)
Clinical Trial of a Rapidly Cycling, Non-Cross Reactive Regimen of Approved Therapeutic Agents to Treat Prostate Cancer
NCT02903160CI-TRIAL-00073762completedPhase 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 purpose of this study is to determine the clinical benefits of using a rapidly cycling, non-cross reactive regimen of FDA-approved prostate cancer therapeutic agents in the management of castration resistant prostate cancer. The hypothesis is that the identification of optimal combinations and sequencing of therapies can help prevent or delay the development of therapeutic drug resistance, and can be safely tolerated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone acetate | Drug | Abiraterone Acetate | ALIAS |
| cabazitaxel | Drug | Cabazitaxel | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Enzalutamide | Drug | Enzalutamide | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Radium-223 dichloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intensive, Non-Cross Reactive Therapy
- description
- Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate; 2. Cabazitaxel + Carboplatin; 3. Enzalutamide + Radium-223
- interventionNames
- Drug: Abiraterone acetate
- Drug: Prednisone
- Drug: Radium-223 dichloride
- Drug: cabazitaxel
- Drug: Carboplatin
- Drug: Enzalutamide
Primary outcomes (1)
- measure
- Time to Disease Progression
- timeFrame
- 47.8 months
- description
- Time to disease progression, as determined by either PSA or radiographic progression, after completion of all modules of the rapidly-cycling, non-cross reactive regimen in patients with mCRPC. Time to progression (TTP) is defined as beginning with the time the first dose of PCD regimen is administered until disease progression.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate * Metastatic castrate resistant prostate cancer, defined by progressive disease based on either rising PSA, new bone metastases, or progression of measurable disease on standard imaging, according to PCWG2 guidelines, despite androgen deprivation therapy * Ongoing androgen deprivation therapy with a GnRH analogue, GnRH antagonist, or bilateral orchiectomy * ECOG performance status 0-1 * Serum testosterone level \< 50 ng/dL * Absolute neutrophil count \> 1,500/μL, platelet count \> 100,000/μL, and hemoglobin \> 9 g/dL * Creatinine \< 2 mg/dL * Total bilirubin \< 1 times the upper limit of normal, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 1.5 times the upper limit of normal Exclusion Criteria: * History of uncontrolled seizure disorder * Clinically significant cardiovascular disease including: 1. Myocardial infarction or uncontrolled angina within 6 months 2. Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past 3. Uncontrolled hypertension as indicated by a resting systolic blood pressure \> 170 mmHg or diastolic blood pressure \> 105 mmHg at the screening visit * Have used or plan to use from 30 days prior to enrollment through the end of the study medication known to lower the seizure threshold or prolong the QT interval * Major surgery within 4 weeks of enrollment * Radiation therapy within 4 weeks of enrollment * Prior use of abiraterone acetate, enzalutamide, docetaxel, cabazitaxel, carboplatin, or radium-223 for the treatment of castration-resistant disease * Prior docetaxel use in the hormone-sensitive disease setting is allowed, but must be completed ≥ 4 weeks prior to enrollment * Prior sipuleucel-T use is allowed, but must be completed ≥ 4 weeks prior to enrollment * Concurrent use of zoledronic acid or denosumab is allowed on study
References
Publications (0)
Data not yet available
No reference posted for this study.