Training for Men Undergoing Androgen Deprivation Therapy. (ADT-train)

ADT-Train - A New Training Concept for Men With Prostate Cancer Receiving Androgen Deprivation Therapy.

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: ADT-train

Detailed Description

Detailed description of the training concept applied in the intervention:

The two weekly training sessions will be separated by at least two days and supervised by appropriately trained exercise professionals at The Swedish School of Sport and Health Sciences. The training includes a 10 min warm-up followed by 3-4 sets of 8 maximal repetitions on the flywheel machine followed by 16-24, 20 s intervals on a Monark cycle ergometer. The intervals will be performed as 3 blocks with the intention to execute 8 intervals in each block. When a participant manages to perform all 3 blocks with 8 intervals in each block (a total of 24 intervals) the resistance will be increased by ~20 W. The rest period between the intervals will be set to 10 s and the rest between the blocks to 2 min. The starting workload of the intervals will be individually adjusted to ~115 % of the participant's power output at VO2peak. The total duration of a training session will be 30-40 min (including worm-up).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Niklas Psilander, PhD; Phone Number: +46 8 120 538 23; Email: niklas.psilander@gih.se

Study Locations

• Sweden
  • Stockholm, Sweden, 11486
    • Recruiting
    • Swedish School of Sport and Health Sciences
    • Contact: Niklas Psilander, PhD; Phone Number: +46 8 120 538 23; Email: niklas.psilander@gih.se
    • Principal Investigator: Niklas Psilander, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. signed informed consent
2. histologically confirmed localised or locally advanced prostate cancer
3. 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise; The participants will exercise twice weekly performing the newly developed training concept including flywheel resistance training followed by aerobic cycling intervals.	Behavioral: ADT-train; A new training concept is tested on men with prostate cancer receiving androgen deprivation therapy
No Intervention: Control group; The participants will receive usual care only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body fat	Assessed by dual-energy x-ray absorptiometry (DEXA) (kg)	Baseline and after 6 and 12 weeks
Lean body mass	Assessed by dual-energy x-ray absorptiometry (DEXA) (kg)	Baseline and after 6 and 12 weeks
Bone mineral density	Assessed by dual-energy x-ray absorptiometry (DEXA) (g/cm2)	Baseline and after 6 and 12 weeks
Quadriceps cross-sectional area	Assessed by ultrasound (mm)	Baseline and after 6 and 12 weeks
Static balance	One leg balance test on the right and the left foot. Time to first footing is measured and the number of footings during 60s.	Baseline and after 6 and 12 weeks
Walk capacity	Usual and fast pace 6m walk test (s)	Baseline and after 6 and 12 weeks
Lower body muscular endurance	30 s chair stand test. Maximal number of sit-to-stand repetitions during 30 s.	Baseline and after 6 and 12 weeks
Blood pressure	Assessed by an automated blood pressure monitor (mmHg).	Baseline and after 6 and 12 weeks
Whole body glucose uptake	Assessed by an oral glucose tolerance test in which the participants will ingest a standardized glucose drink and blood glucose levels will be monitored throughout a period of 2 hours (mmol/L).	Baseline and after 6 and 12 weeks
Whole body insulin response	Assessed by an oral glucose tolerance test in which the participants will ingest a standardized glucose drink and blood insulin levels will be monitored throughout a period of 2 hours (μU/mL).	Baseline and after 6 and 12 weeks
Blood biomarkers related to cardiovascular disease.	Assessed by high-multiplex immunoassays quantifying proteins associated with biological functions linked to cardiovascular diseases. Approximately 100 proteins will be assessed. Examples of proteins are: C-Reactive Protein (CRP), Tissue Factor (F3), and Thrombomodulin (THBD).	Baseline and after 6 and 12 weeks
Muscle fiber cross-sectional area (CSA)	Type I and type II muscle CSA will be assessed by immunohistochemistry (µm2).	Baseline and after 12 weeks
Muscle fiber distribution	Type I and type II muscle fiber distribution will be assessed by immunohistochemistry (%).	Baseline and after 12 weeks
Capillary content	The number of capillaries per muscle fiber will be assessed by immunohistochemistry.	Baseline and after 12 weeks
Myonuclei content	The number of myonuclei per muscle fiber CSA will be assessed by immunohistochemistry.	Baseline and after 12 weeks
Satellite cell content	The number of satellite cells per muscle fiber CSA will be assessed by immunohistochemistry.	Baseline and after 12 weeks
Mitochondrial content	Mitochondrial content will be assessed by measuring citrate synthase activity in homogenized muscle samples (mmol/kg/dw/min).	Baseline and after 12 weeks
Mitochondrial respiration	Mitochondrial respiration will be assessed by respirometry of permeabilized muscle fibers (respiration ratio).	Baseline and after 12 weeks
Genome-wide DNA methylation	Assessed by Illumina EPIC arrays to identify epigenetically regulated genes and pathways associated with exercise and the ADT-treatment.	Baseline and after 12 weeks
Transcriptome-wide RNA expression	Assessed by RNA-sequencing to identify differently regulated genes and pathways associated with exercise and the ADT-treatment.	Baseline and after 12 weeks
Protein expression	Assessed by Western Blot and ELISA (AU). This could for example be proteins related to genes identified by the genome-wide DNA methylation analysis or transcriptome-wide RNA expression analysis.	Baseline and after 12 weeks
Gene expression	Assessed by quantitative real-time PCR (AU). This could for example be genes identified by the genome-wide DNA methylation analysis or transcriptome-wide RNA expression analysis.	Baseline and after 12 weeks
Cancer treatment-related symptoms	Assessed by the National Prostate Cancer Register (NPCR) form. Scores scaled from 0 to 7. A higher score indicates more severe symptoms.	Baseline and after 6 and 12 weeks
Physical activity	Assessed by the physical activity questionnaire. Scores scaled from 1 to 8. A higher score indicates a more physically active participant.	Baseline and after 6 and 12 weeks
Physical and psychological health	Assessed by the Short Form Health Survey (SF-36). Scores scaled from 1 to 6. A higher score indicates better physical and psychological health.	Baseline and after 6 and 12 weeks
Anxiety and depression	Assessed by the Hospital Anxiety and Depression Scale (HADS). Scores scaled from 0 to 3. A higher score indicates more anxiety and depression.	Baseline and after 6 and 12 weeks
Cancer and treatment-related fatigue	Assessed by the Multidimensional Fatigue Inventory survey (MFI-20). Scores scaled from 1 to 5. A higher score indicates more fatigue.	Baseline and after 6 and 12 weeks

Collaborators and Investigators

• Sponsor: The Swedish School of Sport and Health Sciences
• Collaborators: Karolinska Institutet; Sahlgrenska University Hospital, Sweden; Prostate Cancer Foundation; Norwegian School of Sport Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 20, 2028

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Aerobic training; Resistance training; Androgen deprivation therapy (ADT); Flywheel training; High intensity training (HIT)
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2024-00964-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No