Optimising adHERence with A Customised flexibLE multimodal exerciSe regimen in prostate cancer patients on radiation and androgen deprivation therapy - a substudy of HERACLES on adherence

PROTOCOL TITLE

Optimising adHERence with A Customised flexibLE multimodal exerciSe regimen in prostate cancer patients on radiation and androgen deprivation therapy - (HERACLES)

|RATIONALE

A semi-supervised and a flexible personalised prescription of an exercise regimen is likely to improve adherence and consequently improve the quality of life of the prostate cancer patients undergoing androgen deprivation therapy in addition to radiation therapy.

|AIM

Evaluate the effectiveness of incorporation of exercise into the treatment and offering a semi-supervised multimodal exercise regimen in improving exercise adherence of prostate cancer patients undergoing ADT and radiation therapy.

|PRIMARY STUDY OBJECTIVES

To assess whether the prescription of an exercise regimen as part of the treatment and offering a semi-supervised flexible multimodal exercise regimen to prostate cancer patients undergoing androgen deprivation therapy and radiation therapy results in better adherence to the exercise regimen at 24 weeks from the start of androgen deprivation therapy.

|STUDY DESIGN

This will be a two-arm prospective randomised controlled, open-label, parallel-group, superiority trial.

|TRIAL POPULATION

Inclusion criteria

Participants must have all of the following:

1. Confirmed prostatic carcinoma
2. Will undergo radiation therapy - radical radiation therapy or prostate directed radiation therapy
3. Is on androgen deprivation therapy with either medical or surgical methods and is planned to be on this for a minimum duration of 6 months
4. ECOG Performance status 0-1
5. Signed study specific consent form
6. Patient willing and reliable for follow-up

Exclusion criteria

Patients should have none of the following

1. ECOG Performance status 2 or more
2. Limitation in mobility and/or comorbidities that will prevent them from complying to exercise requirements
3. Unable to follow up or poor logistic or social support
4. Deemed to be at high risk of harm due to the presence of lytic bone metastases.

|TREATMENT REGIMEN

ARM 1 (Control Arm): Unsupervised exercise regimen guided by literature and an one-off instruction session on the exercise regimen

ARM 2 (Experimental Arm): A semi-supervised flexible multimodal exercise regimen

|RECRUITMENT TARGET

The trial will recruit 83 patients.

|PRIMARY ENDPOINT

1. Adherence to the prescribed exercise protocol at 24 weeks: A compliance of performing 85% of the exercises required for the week will be considered as adherence for that week. This will be measured using the log maintained by the trial participants and calculating the adherence against the prescribed exercise regimen.

|KEY SECONDARY ENDPOINTS

1. Changes in the Quality of Life as measured by FACT-F, FACT-G and EORTC - PR25 measured at baseline, at 12 weeks and at 24 weeks
2. Functional performance of the patients at baseline, at 12 weeks and at 24 weeks
3. Body Composition of the patients at baseline, at 12 weeks and at 24 weeks