Clinical trial · Interventional
Trial of eRapa in Prostate Cancer Patients
Phase Ib Trial of Encapsulated Rapamycin (eRapa) in Prostate Cancer Patients Under Active Surveillance
NCT03618355CI-TRIAL-00044367completedPhase 1ClinicalTrials.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)
This study is to determine the safety, pharmacokinetics/pharmacodynamics, and immunologic impact of encapsulated rapamycin in patients with low risk prostate cancer under active surveillance. There will be four groups of patients, each receiving a different dose of rapamycin.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| eRapa (encapsulated rapamycin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort 1: 0.5 mg weekly
- description
- Oral administration with consecutive enrollment of overlapping dose-escalation cohorts, total treatment period 3 months. Patients will conclude treatment with previously scheduled standard of care prostate biopsy. eRapa (encapsulated rapamycin) is dosed at 0.5 mg every week.
- interventionNames
- Drug: eRapa (encapsulated rapamycin)
- type
- EXPERIMENTAL
- label
- Cohort 2: 1 mg weekly
- description
- Oral administration with consecutive enrollment of overlapping dose-escalation cohorts, total treatment period 3 months. Patients will conclude treatment with previously scheduled standard of care prostate biopsy. eRapa (encapsulated rapamycin) is dosed at 1 mg every week.
- interventionNames
- Drug: eRapa (encapsulated rapamycin)
- type
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
\-
The patient must:
* Have pathologically (histologically) proven diagnosis of prostate cancer with a Gleason score ≤7 (3+4) and already undergoing active surveillance
* Be able to give informed consent
* Be age 18 or older
Exclusion Criteria:
* Prostate cancer with a Gleason score \>7
* Unable to give informed consent
* Age \< 18
* Immunosuppressed state (e.g., HIV, use of chronic steroids)
* Active, uncontrolled infections
* On medications with strong inhibitors or inducers of CYP3A4 and or P-gp.
* On agents known to alter rapamycin metabolism significantly (Appendix H)
* Have another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin)
* Individuals with a reported history of liver disease (e.g., cirrhosis)
* Individuals who are not a good candidate for active surveillance in their treating physician's opinion
* Have a medical condition (e.g., anemia, anticoagulated) for which repeated phlebotomy may be problematic.
* Uncontrolled hypertension.
* Individuals that have abnormal screening vital organ function prior to enrollment
* Liver Function Test
* Bilirubin \>2.0
* Alkaline phosphatase \>5x upper limit of normal (ULN)
* ALT/AST \>2x ULN
* Complete Blood Count:
* WBC elevated above the normal standard per the testing laboratory
* Hgb/Hct below the normal standards of the testing lab
* Platelets below the normal standards of the testing lab
* Total Cholesterol \>240 mg/dL
* Triglycerides \> 200 mg/dL
* Serum creatinine \>2 and BUN \>30
* Urinary protein: proteinuria \>1+ on urinalysis or \>1 gm/24hrReferences
Publications (0)
Data not yet available
No reference posted for this study.