The Physical Exercise and Prostate Cancer Study

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness of a four months strength training program on physical and psychological health in patients with prostate cancer during androgen deprivation therapy. It is hypothesized a beneficial effect of the intervention on physical and psychological health in patients with prostate cancer treated with androgen deprivation.

Official Title
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Physical Exercise for Patients With Prostate Cancer During Androgen Deprivation Therapy - A Randomized Trial

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Strength training group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed locally advanced prostate cancer (clinical stage T2 and T3) Referred to RH and UUS for radiotherapy < 75 years Capable of reading and writing Norwegian Treating oncologist must approve of the subjects' participation Living within approximately 1 hour from Oslo by car or public transportation Exclusion Criteria: Routinely resistance training with manuals Medication for osteoporosis (i.e. bisphosphonates) Conditions of a severity that contraindicate exercise without adjusted actions Mentally incompetent conditions Conditions of a severity that complicates the ability to participate in a supervised training program

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strength training group<br>A four months strength training program during androgen deprivation therapy for prostate cancer patietns. | Behavioral: Strength training group<br>* After 5-10 months on androgen deprivation therapy the patients in the intervention group go through a four months strength training intervention. The patients will perform three strength-training sessions per week, two under supervision of a sport instructor. Each session will consists of one-three sets of nine strength-training exercises, performed at an intensity of 6 or 10 repetitions of maximum (6-10 RM).<br>* Other names: Exercise, Physical activity;|
| No Intervention: Control group<br>Patients in the control group are not discouraged from performing normal activities. They are however asked not to start a strength training program or increase their activity level in the same period as the experimental group is performing their strength training program. We will offer the control group a modified strength training program after the post-intervention assessment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lean body mass |  | before ADT, before and after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone mineral density, fat mass, body mass index, serological outcomes (including lipids, hormones and CRP), physical functioning, psycho-social functioning and muscle cellular outcomes (including muscle fiber size and function) |  | before ADT, before and after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Prostatic, Neoplasm, Androgen, Deprivation