Clinical trial · Interventional
Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance
A Prospective Study of Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance
- 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)
Agents that inhibit cholesterol synthesis are being investigated in cancers dependent upon cholesterogenesis. Red yeast rice (RYR), is a reddish-purple fermented rice, containing statins which are known to inhibit cholesterol synthesis. Laboratory studies have also shown that RYR has direct effects on androgen dependent and androgen independent prostate cancer cells, inhibiting their growth. It is thought that RYR may have clinical benefit in those subjects with localized prostate cancer who have chosen to be managed by active surveillance.
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 |
|---|---|---|---|
| Red yeast rice | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- red yeast rice (RYR)
- description
- Two RYR capsules three times daily for a minimum of 6 months
- interventionNames
- Drug: Red yeast rice
Primary outcomes (1)
- measure
- Expression of Ki-67 and p27 biomarkers
- timeFrame
- 6 months
- description
- Determine effect of red yeast rice therapy on expression of ki67 and p27 biomarkers in a post-treatment biopsy
Secondary outcomes (3)
- measure
- PSA kinetics
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * histologically diagnosis of prostate adenocarcinoma * being monitored by active surveillance for favourable risk prostate cancer * tumour material from most recent prostate biopsy available with sample * scheduled to have an active surveillance mandated transrectal ultrasound (TRUS) guided biopsy within 6 - 12 months of Day 1 of the study Exclusion Criteria: * previous malignancy in the past 5 years * no previous or concurrent treatment for prostate cancer * inability to undergo TRUS biopsy * ECOG \> 2 * known or previous history of liver disease
References
Publications (0)
Data not yet available