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The Impact of Micronutrients on Gene Expression in Prostate Cancer: Lycopene

The Impact of Micronutrients on Gene Expression in Prostate Cancer: Lycopene

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611001271998
Acronym
ImoGEX(TM)-PC-Lyc
Enrollment
24
Registered
2011-12-12
Start date
2012-02-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to conduct a small, translational research trial in a group of men with prostate cancer, to determine the whole-genome effects of lycopene supplementation.

Interventions

Lycopene - oral supplement 3 times daily - 15-90mg for 6-10 weeks; differs on a case-by-case basis as determined by clinician

Sponsors

University of Queensland
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
Male
Age
35 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

(1) Age 35-80 years (2) Non-smoker (3) Patients with a diagnosis of clinically localised prostate cancer who are scheduled to undergo radical prostatectomy in 6-8 weeks (4) Normal liver function tests, as verification that the tumour is localized to the prostate gland

Exclusion criteria

(1) No diagnosis of prostate cancer (2) Body mass index <18.5kg/m2 (underweight) or >35kg/m2 (obese – class II) (3) Current infection (4) Prior therapy for prostate cancer (e.g. chemotherapy; radiation therapy; hormonal therapy) (5) Current consumption of testosterone replacement medicines (6) Current consumption of 5-alpha-reductase inhibitors (7) Consumption of other herbal or nutritional supplements, apart from a single multi-vitamin tablet (8) Inability to provide informed consent due to diminished understanding or comprehension, or a language other than English spoken and an interpreter unavailable

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026