What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as marine omega-3 fatty acids and 5-alpha-reductase inhibitors, have specific side effects. Marine omega-3 fatty acids are generally well-tolerated but can cause mild gastrointestinal issues like nausea and diarrhea. 5-alpha-reductase inhibitors, including finasteride and dutasteride, are associated with decreased libido, erectile dysfunction, and gynecomastia. They can also reduce prostate-specific antigen (PSA) levels, potentially complicating cancer monitoring.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that align with the mechanisms being studied in the trial involving Marine Omega-3 Fatty Acids and 5-Alpha-Reductase Inhibitors. Notably, 5-Alpha-Reductase Inhibitors like finasteride and dutasteride are approved for reducing prostate size and managing symptoms of benign prostatic hyperplasia, which can be relevant in prostate cancer management. Additionally, anti-inflammatory properties of omega-3 fatty acids are being explored for their potential benefits in cancer cachexia and overall cancer management. Broadly, other FDA-approved treatments for prostate cancer include androgen deprivation therapy (ADT), abiraterone acetate, and enzalutamide, which target androgen receptor signaling pathways.

What other types of research exist?

Promising alternatives to Marine Omega-3 Fatty Acids and 5-Alpha-Reductase Inhibitors for prostate cancer treatment include Saw Palmetto and Pygeum africanum. Saw Palmetto inhibits 5-alpha-reductase and has anti-inflammatory properties, while Pygeum africanum also offers therapeutic benefits for the prostate.

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Dutasteride + Dietary Interventions for Prostate Cancer

N/A

Waitlist Available

Led By Vincent Fradet, MD

Research Sponsored by CHU de Quebec-Universite Laval

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Current NSAID use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-6-12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a special diet with fish oils and a prostate medication can slow down cancer in men with low-risk prostate cancer. The fish oils may reduce inflammation, and the medication lowers hormones that help cancer grow.

Who is the study for?

This trial is for individuals with low-risk prostate cancer who are candidates for active surveillance and have given informed consent. It's not open to those currently taking fish oil supplements or NSAIDs.

What is being tested?

The study is testing the effectiveness of marine omega-3 fatty acids (dietary intervention) and Dutasteride (a drug), separately, in slowing down the progression of low-risk prostate cancer.

What are the potential side effects?

Dutasteride may cause sexual side effects, such as decreased libido, erectile dysfunction, or ejaculation disorders. Dietary interventions could lead to changes in digestion or allergies.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently taking NSAID medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-6-12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-6-12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-6-12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effects of the Interventions on Lipid Metabolism From Blood and Prostatic Microenvironment

Secondary study objectives

Determine the Clinical Utility of Urine-Based Cancer Markers in the Context of Interventions to Reduce Cancer Progression

Effect of Interventions on Gene Expression Profile

Effects of Interventions on Hormonal Metabolism

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Drug intervention firstExperimental Treatment1 Intervention

Intake of 5α-Reductase Inhibitor

Group II: Dietary intervention firstExperimental Treatment1 Intervention

The dietary intervention will be aimed to increase intake of ω-3 long chain fatty acids and to reduce intake of saturated and trans fatty acids.

0 / 1Eligibility 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

Marine omega-3 fatty acids, with their anti-inflammatory properties, may help reduce inflammation and slow the progression of prostate cancer. 5-alpha-reductase inhibitors block the conversion of testosterone to dihydrotestosterone (DHT), a hormone that can promote prostate cancer growth. These mechanisms are important for prostate cancer patients as they target specific pathways involved in cancer progression, potentially improving treatment outcomes and quality of life.

Screening and hormonal therapy of localized prostate cancer shows major benefits on survival.