Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02631681
Other study ID # ProstEx
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2014
Est. completion date September 2017

Study information

Verified date August 2019
Source Herlev Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Exercise intervention for men with prostate cancer on androgen deprivation therapy.


Description:

The aim of the project is to investigate the effects of patient education and exercise intervention implemented in daily clinical practice for men with prostate cancer on androgen deprivation therapy

- Functional capacity

- Quality of life

- Body composition

- Blood pressure

and to assess safety of progressive resistance training for participants with bone metastases.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with a prostate cancer diagnosis on androgen deprivation therapy

Exclusion Criteria:

- Opioid demanding treatment for skeletal pain

- Eastern Cooperative Oncology Group performance status > 2

- Inability to perform floor and machine exercises independently

Study Design


Intervention

Behavioral:
Group based exercise
Supervised group based combined aerobic and resistance training for 12 weeks as part of our normal clinical practice.

Locations

Country Name City State
Denmark Herlev and Gentofte Hospital Herlev Please Select An Option Below

Sponsors (1)

Lead Sponsor Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in 30second Chair-Stand test (30s-CST) Test of functional capacity, measured as change Baseline, 12 and 24 weeks
Primary Change in Graded Cycling Test with Talk Test (GCT-TT) Test of functional capacity, measured as change Baseline, 12 and 24 weeks
Secondary change in QoL European Organisation for Research and Treatment of Cancer (EORTC) cancer and prostate specific questionnaires: EORTC QLQC-30 version 3.0 and PR25 Baseline, 12 and 24 weeks
Secondary change in Body composition BMI, waist and hip circumference, waist-hip ratio. Baseline, 12 and 24 weeks
Secondary change in Bloodpressure Systolic and diastolic bloodpressure Baseline, 12 and 24 weeks
Secondary Safety of exercise assessed by serious adverse events according to the FDA Study period baseline - 24 weeks
Secondary Compliance assessed by attendance and continued exercise (yes/no) Baseline, 12 and 24 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04964271 - Identification of Prostate Cancer Specific Markers in Patients Compared to Healthy Participants
Completed NCT02546908 - A Registry of Participants With Prostate Cancer in Asia
Completed NCT04838626 - Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection Phase 2/Phase 3
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT01683994 - Cabozantinib Plus Docetaxel and Prednisone for Advanced Prostate Cancer Phase 1/Phase 2
Completed NCT04838613 - Study of Diagnostic Performance of [18F]CTT1057 in BCR Phase 3
Completed NCT02364531 - A Canadian Observational Study in Metastatic Cancer of the Prostate: A Study of ZYTIGA Use in the Community Urology Setting
Completed NCT01929655 - Japanese BAY88-8223 Monotherapy Phase II Study Phase 2
Active, not recruiting NCT05022849 - A Study of JNJ-75229414 for Metastatic Castration-resistant Prostate Cancer Participants Phase 1
Completed NCT03261999 - Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer Phase 3
Terminated NCT04907227 - Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)-China Extension Phase 3
Active, not recruiting NCT03587285 - A Pilot Study of Hormonal Therapy Combined With Central Memory T Cells (Tcm) for Patients With Advanced Prostate Cancer Phase 1/Phase 2
Completed NCT02217566 - Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy Phase 2
Not yet recruiting NCT04101305 - Measurement of Circulating Tumor Cells in Prostate Cancer
Active, not recruiting NCT02950064 - A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations Phase 1
Terminated NCT03066154 - Oral Docetaxel (ModraDoc/r) in Combination With Hormonal Treatment and Radiation Therapy in High-risk Prostate Cancer Phase 1
Withdrawn NCT02905201 - A Prospective Compliance Registry for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) N/A
Completed NCT02692976 - Natural Dendritic Cells for Immunotherapy of Chemo-naive Metastatic Castration-resistant Prostate Cancer Patients Phase 2
Terminated NCT01420965 - Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer Phase 2
Completed NCT01441713 - Treatment Frequency and Satisfaction in Patients With Advanced Prostate Cancer N/A