Phase 2
N=40
Prostate Cancer Intensive, Non-Cross Reactive Therapy (PRINT) for Castration Resistant Prostate Cancer (CRPC)
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02903160 ↗Enrolled (actual)
40
Serious AEs
30.3%
Results posted
Feb 2024
Primary outcome: Primary: Time to Disease Progression — 15.2 weeks
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Abiraterone acetate (Drug); Prednisone (Drug); Radium-223 dichloride (Drug); cabazitaxel (Drug); Carboplatin (Drug); Enzalutamide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Disease Progression |
15.2 | — |
| SECONDARY Overall Survival (OS) |
NA | — |
| SECONDARY Overall Rate of Survival |
63 | — |
| SECONDARY Number of Participants With PSA Response Rate >90% |
11; 14; 20 | — |
| SECONDARY Number of Participants With PSA Response Rate >=50% |
27; 28; 32 | — |
| SECONDARY Number of Participants With PSA Progression Compared to Baseline. |
4; 4; 0 | — |
| SECONDARY Number of Participants With Stable PSA as Compared to Baseline |
2; 1; 1 | — |
| SECONDARY Number of Participants With Normal Alkaline Phosphatase Levels |
8 | — |
Summary
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.
Eligibility Criteria
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 1, 500/μL, platelet count > 100,000/μL, and hemoglobin > 9 g/dL
- Creatinine 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
Data sourced from ClinicalTrials.gov (NCT02903160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.