NCT01584960

Brief Summary

The aim of the present study is to investigate the effect of endurance on PSA doubling time in prostate cancer patients with an elevation in PSA following radical prostatectomy for localized cancer. Furthermore, underlying mechanisms such as reduction in inflammatory markers and improvement in insulin sensitivity and body composition are investigated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Apr 2008

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2012

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

December 2, 2013

Status Verified

November 1, 2013

Enrollment Period

4.1 years

First QC Date

April 24, 2012

Last Update Submit

November 29, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • PSA doubling time

    2 years

Secondary Outcomes (1)

  • Insulin sensitivity, body composition and inflammation status

    0 months, 6 months and 24 months of training

Study Arms (1)

Prostate cancer, endurance training

EXPERIMENTAL

Prostate cancer patients doing 2 years of home-based endurance training Cross over design with a control group with no intervention

Behavioral: endurance training

Interventions

2 years of home-based endurance training

Prostate cancer, endurance training

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prostate cancer patients with an increase in PSA following radical prostatectomy

You may not qualify if:

  • severe cardiovascular disease
  • severe arthritis
  • severe neuropathy
  • severe hypertension
  • therapy with antidiabetic agents
  • other treatment for prostate cancer than radical prostatectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre of Inflammation and Metabolism, Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Prostatic NeoplasmsInsulin ResistanceGlucocorticoid Receptor Deficiency

Interventions

Endurance Training

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Bente K Pedersen

    Centre of Inflammation and Metabolism, Rigshospitalet

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Administrator

Study Record Dates

First Submitted

April 24, 2012

First Posted

April 25, 2012

Study Start

April 1, 2008

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

December 2, 2013

Record last verified: 2013-11

Locations