What side effects are associated with this type of intervention?

Common treatments for prostate cancer include surgery, radiation therapy, hormone therapy, chemotherapy, and the use of antioxidants like lycopene. Surgery and radiation therapy can cause urinary incontinence and erectile dysfunction. Hormone therapy may lead to hot flashes, reduced libido, and osteoporosis. Chemotherapy can result in fatigue, nausea, hair loss, and increased risk of infections. Antioxidants like lycopene, which are being studied for their potential to prevent cancer formation, generally have mild side effects such as gastrointestinal discomfort. However, the efficacy and safety of lycopene specifically for prostate cancer prevention require further research.

What prior FDA approvals exist?

FDA-approved treatments for prostate cancer primarily include hormone therapies, chemotherapy, and targeted therapies. While lycopene, an antioxidant found in tomatoes, is being studied for its potential to prevent prostate cancer, it is not yet FDA-approved for this purpose. Current treatments with antioxidant properties are not specifically highlighted in the provided context. However, the focus remains on established therapies like androgen deprivation therapy (ADT), drugs such as abiraterone and enzalutamide, and chemotherapeutic agents like docetaxel.

What other types of research exist?

Promising novel alternatives to Lycopene for prostate cancer patients include Selenium and Vitamin E, as they have been studied for their antioxidant properties and potential in cancer prevention. Additionally, ongoing research into other antioxidants such as Vitamin C and various phytochemicals may provide further options.

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Carotenoid

Lycopene for Preventing Prostate Cancer

N/A

Waitlist Available

Led By Richard B. van Breemen, PhD

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No existing gastrointestinal disease or cancer

No existing prostate disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is studying whether the supplement lycopene can prevent prostate cancer.

Who is the study for?

This trial is for healthy men who don't abuse alcohol or drugs, have no prostate disease or cancer, and aren't allergic to tomatoes. They must not be in the hospital, able to give blood and urine samples, and willing to answer health and diet questionnaires. Men already taking lycopene supplements or in another trial can't join.Check my eligibility

What is being tested?

The study is testing if lycopene (a substance from tomatoes) can prevent prostate cancer when compared with a placebo (a harmless pill). Participants will be randomly assigned to receive either lycopene or the placebo without knowing which one they are getting.See study design

What are the potential side effects?

Lycopene is generally considered safe but may cause digestive issues like bloating, indigestion, nausea, diarrhea; skin discoloration; and allergies in those sensitive to tomatoes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I do not have any gastrointestinal diseases or cancer.

Select...

I do not have any prostate disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measurement of changes in percent free and total serum prostate-specific antigen (PSA) induced by lycopene

Side effects data

From 2014 Phase 4 trial • 28 Patients • NCT02587117

69%

Flatulency

31%

Nausea

23%

Increased appetite

15%

Abdominal distension

15%

Diarrhea

Headache

Dizziness

100%

80%

60%

40%

20%

Study treatment Arm

Lycopene Group

Prednisolone Group

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm IIExperimental Treatment1 Intervention

Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks.

Group II: Arm IExperimental Treatment1 Intervention

Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks.

Group III: Arm IIIPlacebo Group1 Intervention

Participants receive oral placebo twice daily for 3 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

lycopene

2008

Completed Phase 4

~260

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer include antioxidants like lycopene, which may prevent cancer formation by neutralizing free radicals and reducing oxidative stress. Hormone therapy reduces androgen levels to slow cancer growth, while chemotherapy targets rapidly dividing cancer cells. Understanding these mechanisms is crucial for selecting the most effective treatment based on the cancer's characteristics and the patient's health.

Lycopene for the prevention of prostate cancer.