Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Immune System Diseases

Behaviors and Mental Disorders

Prostatic Neoplasms

Inflammation

Hypersensitivity

Disease Progression

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

Hypoglycemic Agents

All Drugs and Chemicals

Insulin

Insulin, Globin Zinc

Prescriptions: Vigorous exercise (average 65-70% of maximal oxygen consumption) minimum 3 times 45 minutes per week according to customized endurance training programs.

Restrictions: None.

Exercise

Prescriptions: Minimum 170-180g of whole grain rye intake per day. Restrictions: None.

Whole grain rye

Recommendations on a health-promoting, energy restricted diet according to Danish Nutrition Recommendations and encouraged to walk at least 10,000 steps every day.

Recommendations

Anne Tjønneland, Dr.Med.Sci.

Rikke D Hansen, Dr.

Michael Borre, Prof.

PURPOSE:

To evaluate the feasibility of a future Nordic intervention trial, including vigorous activity and a high intake of whole grain rye, among prostate cancer patients on active surveillance.

Additionally, to investigate effects of the lifestyle intervention according to cancer progression, the metabolic profile, inflammation and quality of life among prostate cancer patients on active surveillance.

In the present feasibility study it will be established whether it is possible to enroll participants for this particular kind of intervention among this particular patient group, and if compliance with the intervention is possible to gain by the tools planned: individual counselling with a dietician and a physiologist, interviews on diet, exercise tests and diaries on diet, exercise and steps taken.

Furthermore, the investigators will investigate if we are able to detect effects of the lifestyle intervention according to cancer progression, the metabolic profile, inflammation and quality of life among the participants (24 men) within the short intervention period (6 months) for this particular feasibility study.

Biomarkers of effect and compliance are measured in blood, urine and prostate tissue samples. Metabolomics and the following biomarkers are measured in blood and urine samples: Alkyl resorcinols, enterolactone, tnf receptor 2, e-selectin. ICAM1, IL1-alpha, IL6, triglycerides, HDL/LDL, s-insulin, HbA1c, C-peptide, CRP, IGF1, GLP1, cholesterol, cathepsin and glucose.

Feasibility Study on a Nordic Lifestyle Intervention Trial Among Men With Prostate Cancer

Feasibility Study on a Nordic Lifestyle Intervention Trial Investigating the Effect of Vigorous Activity and Intake of Whole Grain Rye on Cancer Progression, Insulin Sensitivity and Inflammation Among Men With Early Stage Prostate Cancer.

Feasibility of an intervention trial is evaluated among Danish men with early stage prostate cancer. Enrollment of participants, possible for this particular type of trial among the particular patient group? Compliance with intervention, obtainable for intervention participants with the tools planned (counseling sessions, exercise programs, supply of rye products, sphygmographs and pedometers)? Does the design minimize drop out? Is the schedule for monitoring, counseling, testing and collection of biological samples efficient and feasible for the research team and for the participants?

PSA is measured at baseline and 3, 6 and 12 months after baseline among all participants. Prostate biopsies are made at baseline and 6 months after baseline among all participants.

Oral glucoce tolerance test is made among all participants at baseline, and 3, 6 and 12 months after baseline.

C peptide levels will be measured in 24h urine samples the following year after the intervention. The urine samples are collected at baseline, and 3, 6 and 12 months after baseline from all participants.

Life quality is evaluated by questionnaires answered by all participants at baseline, and 6 and 12 months after baseline.

The following measurements are made at baseline, and 3, 6 and 12 months after baseline among all participants: Bioimpedance, skin fold analysis, waist and hip circumference, weight and height, and blood pressure.

CRP is measured among all participants at baseline, and 3, 6 and 12 months after baseline.

Aarhus University Hospital

University of Aarhus

European Commission

Danish Cancer Society

Principal Investigator / Project Manager

Recurrence

Disease Attributes

Other Dietary Supplements

Herbal and Botanical

Androgens

Omega 3 Fatty Acid

Sunflower

5g/day of omega-3-rich fish oil capsules, which include 4g of purified EPA, to be taken once a day, for 12 months.

5g/day of high-oleic sunflower oil capsules, to be taken once a day, for 12 months.

5g/day of omega-3-rich fish oil including 4g of purified monoglycerides EPA, capsules, taken once daily, for 12 months

MAG-EPA

5g/day of placebo (high oleic sunflower oil), capsules, taken once daily, for 12 months

Placebo group

Vincent Fradet, MD, PhD

Carole Plante, Inf

Prostate cancer biochemical recurrence (BCR) occurs in 20-50% of patients following radical prostatectomy or radiotherapy. Due to significant risk of side effects and uncertainty about the benefits, physicians and patients are seeking alternatives to delay androgen deprivation therapy (ADT) for non-metastatic BCR. Long-chain omega-3 fatty acids (LCn3), mainly found in seafood and fatty fish, have beneficial effects against prostate cancer in pre-clinical experimental studies and randomized clinical trials of intermediate prostate cancer outcomes. The current observational evidence also supports testing LCn3 in prostate cancer patients. LCn3 have beneficial effects on inflammation, cardiovascular, psychological, and other outcomes, contrasting sharply with ADT-associated side effects.

Investigators propose to conduct a pilot randomized placebo-controlled trial to determine the effects over one year of an innovative LCn3 supplement (5g of omega-3-rich fish oil daily, including 4g of monoglycerides eicosapentaenoic acid (MAG-EPA)) in 40 men experiencing BCR or prostate cancer progression after a curative treatment.

This project proposes a simple intervention by dietary supplementation that could eventually help to prevent or delay ADT-related side effects and thus could contribute to diminish the heavy individual and societal burden of prostate cancer. The clinical data generated by this pilot trial will serve as basis for a larger-scale phase II clinical trial.

Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer.

Étude Pilote randomisée de Phase IIB, contrôlée Par placébo, évaluant l'Effet thérapeutique d'Une supplémentation en Omega-3 (Principalement EPA) Chez Des Patients en récidive Biochimique ou en Progression du Cancer de la Prostate.

Efficacy of a one-year MAG-EPA supplementation versus placebo on PSA kinetics will be evaluated based on the comparison of PSA doubling time from baseline to 12 months. The investigators will measure PSA level every three months and calculate PSA doubling time at 12 months (using a linear regression approach) after randomisation using the randomisation PSA value as the starting point. PSA slope will be defined as the linear regression line of the natural log of PSA (in ng/mL) against time (in months). PSA doubling time will be defined as the natural log of 2 divided by the PSA slope.

The changes of fatty acid levels in red blood cell membranes, relative to their baseline levels, will be measured every three months. The profile of fatty acids will be quantified using gas chromatography coupled with mass spectrometry and expressed as relative percentages of total fatty acids.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility Study on a Nordic Lifestyle Intervention Trial Among Men With Prostate Cancer	NCT01300104	Prostate Cancer	Exercise Whole grain rye Recommendations	55 Years - 70 Years	Danish Cancer Society
Feasibility Study on a Nordic Lifestyle Intervention Trial Among Men With Prostate Cancer	NCT01300104	Prostate Cancer	Exercise Whole grain rye Recommendations	55 Years - 70 Years	Danish Cancer Society
Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer.	NCT03753334	Prostate Cancer	MAG-EPA Placebo group	18 Years - 100 Years	CHU de Quebec-Universite Laval
Feasibility Study on a Nordic Lifestyle Intervention Trial Among Men With Prostate Cancer	NCT01300104	Prostate Cancer	Exercise Whole grain rye Recommendations	55 Years - 70 Years	Danish Cancer Society
Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer.	NCT03753334	Prostate Cancer	MAG-EPA Placebo group	18 Years - 100 Years	CHU de Quebec-Universite Laval

Spots Global Cancer Trial Database for prostate cancer progression