ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000225213

Ethics application status

Approved

Date submitted

31/01/2018

Date registered

12/02/2018

Date last updated

14/01/2021

Date data sharing statement initially provided

30/08/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Exercise for men with prostate cancer on active surveillance

Scientific title

Can exercise delay transition to active therapy in men with low grade prostate cancer? A multi-centre randomized controlled trial

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Prostate Cancer

Condition category

Condition code

Cancer

Prostate

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This is a single-blinded (investigators blinded to group allocation), two arm, multi-centre RCT that will examine the efficacy of combined resistance and aerobic exercise during AS on disease progression in men with low-risk PCa. An ‘Exercise’ group will complete a 6-month supervised exercise intervention followed by a stepped down program for 6 months and a subsequent self-managed maintenance program for 2 years.

One hundred and sixty-eight men (84 subjects per arm) within 1 year of prostate biopsy and undergoing AS will be recruited by invitation of their attending specialist from two Australian cities (Perth and Melbourne). Patients suitable for AS will be selected from the Multi-Disciplinary Uro-Oncology meeting at the recruiting site. Inclusion criteria are: 1) histologically proven adenocarcinoma of the prostate, 2) no prior therapy for PCa, 3) fit for curative intent therapy, 4) willing to attend follow-up, 5) clinical stage less than or equal to T2, 6) less than or equal to 10 % Gleason pattern 4 disease on biopsy with no more than 2 cores positive for cancer, and 7) PSA less than or equal to 10ng/ml. Exclusion criteria are: 1) already performing regular exercise defined as undertaking structured resistance and aerobic training two or more times per week within the past 3 months, 2) acute illness or any musculoskeletal, cardiovascular or neurological disorder that could inhibit exercise performance or put participants at risk from exercising, 3) variant histopathology (small cell, intra-ductal, sarcomatoid), presence of extra-prostatic extension (EPE) or lympho-vascular invasion (LVI), 4) patient no longer considered a candidate for curative intent treatment, and 5) intention to move place of residence away from the two study sites. Eligible subjects will undertake baseline measurements prior to randomisation.

The exercise intervention will consist of supervised resistance and aerobic exercise performed over 3 sessions per week for 6 months in an exercise clinic setting. During months 7-12, the exercise intervention group will transition to once a week supervised exercise in a clinic for months 7-8, once every two weeks supervised exercise in months 9-10, and once per month supervised exercise in months 11-12. This stepped down approach will include a self-managed exercise program consisting of a booklet (designed specifically for this study) and training log with detailed information about the exercise prescription and how to implement in a variety of settings. Participants will be encouraged and supported to continue their aerobic and resistance exercise program in their local fitness centre or other exercise facilities where they can maintain a high-quality exercise program under their self-management. The self-managed exercise program is designed to replicate the exercises performed in the supervised sessions and includes resistance, aerobic and flexibility exercises. Finally, from month 13 to 36 the exercise program will exclusively consist of a self-managed program and has been implemented by our group previously in a multicentre year-long trial in men with PCa on active therapy. The initial program will be supervised by exercise physiologists in Perth and Melbourne. Patient attendance/adherence will be recorded using training diaries.
The exercise program is designed to provide optimal stimulus to the cardiorespiratory and neuromuscular systems while maximising safety, compliance and retention. The exercise sessions will be conducted in small groups of up to 10-12 participants exercising in pairs under direct supervision to ensure correct technique and minimise the risk for injury. Resistance exercise will involve 6-8 exercises that target the major upper and lower body muscle groups. Intensity will be manipulated from 6-12 repetition maximum (RM; i.e. the maximal weight that can be lifted 6 to 12 times which is equivalent to ~60-85% of 1RM) using 1-4 sets per exercise. The aerobic exercise component will include 20 to 30 minutes of moderate to vigorous intensity cardiovascular exercise (~60-85% of estimated maximum heart rate) using a variety of modes such as walking or jogging on a treadmill, cycling or rowing on a stationary ergometer. Participants will be encouraged to undertake additional aerobic exercise outside the clinic sessions with the goal of achieving a total of at least 150 minutes of moderate to vigorous intensity aerobic exercise each week. Exercise prescription will be progressive and modified according to individual response. Both moderate intensity continuous and high intensity interval training will be implemented to provide greater variety and training stimulus. To reduce the possibility of boredom and over-reaching, the exercise program will be periodised by cycling emphasis on intensity and volume. We have used this exercise prescription effectively in previous trials involving men with PCa and have reported significant improvements in quality of life, lean muscle mass, fatigue, aerobic capacity and physical function. The step-down approach to self-management is intended to maximise the translation of this intervention to best practice management of this patient population.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The usual care group will receive an unsupervised walking program and an educational booklet (designed specifically for this study), outlining the current national physical activity recommendation for cancer survivors along with a logbook to record their physical activity. During the study, both groups will be encouraged to maintain customary dietary patterns and the Mini Nutritional Assessment will be used to monitor nutritional status.

Control group

Active

Outcomes

Primary outcome [1]

Transition to active therapy measured by the number of patients undergoing active therapy (radical prostatectomy, radiotherapy, or androgen deprivation), and the time they began active therapy Data will be extracted directly from Urologist Clinical Investigators as part of their routine clinical practice, therefore all patients will be captured.

Timepoint [1]

Baseline, 6 months, 12 months (primary endpoint), 24 months, 36 months

Secondary outcome [1]

Disease Progression (PSA levels greater than or equal to 10 microgram/L) will be determined by a blood sample. A 30ml venous blood sample will be collected by an Australian National Association of Testing Authorities accredited laboratory.

Timepoint [1]