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Prostate Cancer Intensive, Non-Cross Reactive Therapy (PRINT) for Castration Resistant Prostate Cancer (CRPC)
Phase 2 trial testing Abiraterone acetate in Prostate Cancer in 40 participants. Completed in 15 November 2021.
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 13 January 2017 |
| Primary completion | 15 November 2021 |
| Estimated completion | 15 November 2021 |
| Sites | 2 locations across United States |
Icahn School of Medicine at Mount Sinai
18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Intensive, Non-Cross Reactive Therapy | 15.2 | 10.8 – 23.2 |
Overall survival defined as the time of study entry to death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| Intensive, Non-Cross Reactive Therapy | NA | NA – NA |
Overall rate of survival at 40 months. Overall rate of Survival as defined by likelihood that a participant on the study is still alive at 40 months follow up
| Group | Value | 95% CI |
|---|---|---|
| Intensive, Non-Cross Reactive Therapy | 63 | 47 – 85 |
PSA response rate - \>90% decrease in PSA compared to baseline
| Group | Value | 95% CI |
|---|---|---|
| Intensive, Non-Cross Reactive Therapy | 11 |
| Group | Value | 95% CI |
|---|---|---|
| Intensive, Non-Cross Reactive Therapy | 14 |
| Group | Value | 95% CI |
|---|---|---|
| Intensive, Non-Cross Reactive Therapy | 20 |
Number of participants with PSA response rate \>=50% decrease in PSA compared to baseline
| Group | Value | 95% CI |
|---|---|---|
| Intensive, Non-Cross Reactive Therapy | 27 |
| Group | Value | 95% CI |
|---|---|---|
| Intensive, Non-Cross Reactive Therapy | 28 |
| Group | Value | 95% CI |
|---|---|---|
| Intensive, Non-Cross Reactive Therapy | 32 |
PSA changes was reported globally using a waterfall plot for each module. In participants who have a decline in PSA value from baseline, progression is defined by: * An increase in PSA by 25% above the nadir, AND * An increase in PSA by a minimum of 2 ng/ml, or an increase in PSA to the pre-treatment PSA value, AND * Confirmation by a second PSA at least 3 weeks apart, AND * Occur following at least 12 weeks of therapy, AND * There is no objective evidence of disease response. In participants whose PSA value from baseline has not declined from baseline, progression is defined by: * An incre
| Group | Value | 95% CI |
|---|---|---|
| Intensive, Non-Cross Reactive Therapy | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Intensive, Non-Cross Reactive Therapy | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Intensive, Non-Cross Reactive Therapy | 0 |
Participants with a 50% PSA decline from their baseline PSA level will be considered responders, provided objective tumor measurements are stable or also demonstrate response. Participants with a 25% PSA increase from their baseline PSA will be considered nonresponders. Participants that do not meet criteria for responder or nonresponder, will be considered to have stable disease.
| Group | Value | 95% CI |
|---|---|---|
| Intensive, Non-Cross Reactive Therapy | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Intensive, Non-Cross Reactive Therapy | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Intensive, Non-Cross Reactive Therapy | 1 |
Number of participants who converted from elevated to normal range of alkaline phosphatase levels at 9 months from baseline
| Group | Value | 95% CI |
|---|---|---|
| Intensive, Non-Cross Reactive Therapy | 8 |
Time frame: Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Intensive, Non-Cross React… |
|---|---|---|
| diarrhea | Gastrointestinal disorders | — |
| neutrophil count decreased | Blood and lymphatic system disorders | — |
| hyperglycemia | Endocrine disorders | — |
| vomiting | Gastrointestinal disorders | — |
| nausea | Gastrointestinal disorders | — |
| lymphocyte count decreased | Blood and lymphatic system disorders | — |
| platelet count decreased | Blood and lymphatic system disorders | — |
| blood bilirubin increased | Hepatobiliary disorders | — |
| Reaction | System | Intensive, Non-Cross React… |
|---|---|---|
| fatigue | General disorders | — |
| diarrhea | Gastrointestinal disorders | — |
| nausea | Gastrointestinal disorders | — |
| lymphocyte count decreased | Blood and lymphatic system disorders | — |
| white blood cell count decreased | Blood and lymphatic system disorders | — |
| anorexia | Gastrointestinal disorders | — |
| anemia | Blood and lymphatic system disorders | — |
| peripheral sensory neuropathy | Nervous system disorders | — |
| vomiting | Gastrointestinal disorders | — |
| hyperglycemia | Endocrine disorders | — |
| platelet count decreased | Blood and lymphatic system disorders | — |
| hot flashes | Endocrine disorders | — |
| neutrophil count decreased | Blood and lymphatic system disorders | — |
| aspartate aminotransferase increased | Hepatobiliary disorders | — |
| dysgeusia | Gastrointestinal disorders | — |
| alanine aminotransferase increased | Hepatobiliary disorders | — |
| dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| hypertension | Cardiac disorders | — |
| dizziness | Nervous system disorders | — |
| generalized muscle weakness | Musculoskeletal and connective tissue disorders | — |
| arthralgia | Musculoskeletal and connective tissue disorders | — |
| bloating | Gastrointestinal disorders | — |
| constipation | Gastrointestinal disorders | — |
| edema limbs | Vascular disorders | — |
| bone pain | Musculoskeletal and connective tissue disorders | — |
| abdominal pain | Gastrointestinal disorders | — |
| atrial flutter | Cardiac disorders | — |
| creatinine increased | Renal and urinary disorders | — |
| dyspepsia | Gastrointestinal disorders | — |
| dysphagia | Gastrointestinal disorders | — |
| flu like symptoms | Immune system disorders | — |
| gastroesophageal reflux disease | Gastrointestinal disorders | — |
| hypoalbuminemia | Hepatobiliary disorders | — |
| hypokalemia | Renal and urinary disorders | — |
| hypotension | Cardiac disorders | — |
| infusion related reaction | General disorders | — |
| blood lactate dehydrogenase increased | General disorders | — |
| muscle cramp | Musculoskeletal and connective tissue disorders | — |
| muscle weakness lower limb | Musculoskeletal and connective tissue disorders | — |
| malaise | General disorders | — |
Most-reported serious reactions: diarrhea, neutrophil count decreased, hyperglycemia, vomiting, nausea, lymphocyte count decreased, platelet count decreased, blood bilirubin increased.
Data from ClinicalTrials.gov NCT02903160 adverse events section.
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.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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