NCT06449664

Brief Summary

The goal of this clinical trial is to evaluate the effects of a newly developed training concept on men with prostate cancer undergoing androgen deprivation therapy (ADT). The main questions it aims to answer are:

  • How feasible and safe is the new training concept?
  • How efficient is the training concept to counteract side effects caused by ADT? Researchers will compare the new training concept with usual care to evaluate how efficient the training concept is to counteract the ADT-related side effects. Participants in the intervention group will perform the new training concept twice weekly for 12 weeks. Participants in the control group will only receive usual care. All participants will visit the laboratory at baseline and after 6 and 12 weeks to measure the primary and secondary outcomes.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
31mo left

Started May 2024

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
May 2024Dec 2028

First Submitted

Initial submission to the registry

April 4, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2028

Last Updated

June 10, 2024

Status Verified

June 1, 2024

Enrollment Period

2.6 years

First QC Date

April 4, 2024

Last Update Submit

June 3, 2024

Conditions

Prostate Cancer

Keywords

Androgen deprivation therapy (ADT)Flywheel trainingHigh intensity training (HIT)Resistance trainingAerobic training

Outcome Measures

Primary Outcomes (2)

  • Aerobic fitness

    VO2peak (ml/kg/min); incremental ramp test on a cycle ergometer

    Baseline and after 6 and 12 weeks

  • Maximal leg strength

    Isometric squat test (N) measured on force plates

    Baseline and after 6 and 12 weeks

Secondary Outcomes (27)

  • Body fat

    Baseline and after 6 and 12 weeks

  • Lean body mass

    Baseline and after 6 and 12 weeks

  • Bone mineral density

    Baseline and after 6 and 12 weeks

  • Quadriceps cross-sectional area

    Baseline and after 6 and 12 weeks

  • Static balance

    Baseline and after 6 and 12 weeks

  • +22 more secondary outcomes

Study Arms (2)

Exercise

EXPERIMENTAL

The participants will exercise twice weekly performing the newly developed training concept including flywheel resistance training followed by aerobic cycling intervals.

Behavioral: ADT-train

Control group

NO INTERVENTION

The participants will receive usual care only.

Interventions

ADT-trainBEHAVIORAL

A new training concept is tested on men with prostate cancer receiving androgen deprivation therapy

Exercise

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • signed informed consent
  • histologically confirmed localised or locally advanced prostate cancer
  • planned radiotherapy in combination with ADT for at least six months (unfavorable intermediate risk and high-risk prostate cancer) with curative intent and with no known metastasis.

You may not qualify if:

  • very high risk localised prostate cancer planned for radiotherapy and ADT plus abiraterone and cortisone
  • localized prostate cancer planned for radiotherapy without ADT
  • on-going or previously treated with ADT or other hormonal treatments
  • have any contraindications to physical testing/exercise as per the ACSM guidelines
  • unable to comply with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swedish School of Sport and Health Sciences

Stockholm, 11486, Sweden

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Niklas Psilander, PhD

CONTACT

+46 8 120 538 23niklas.psilander@gih.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2024

First Posted

June 10, 2024

Study Start

May 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 20, 2028

Last Updated

June 10, 2024

Record last verified: 2024-06

Locations

SE(1)