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Prostate Cancer Patients Undergoing Radical ProstatectomyPhase 1/2NCT02036684

Prehabilitation for Prostate Cancer Surgery

A Phase 1/2 study testing Prehabilitation (PREHAB) in people with Prostate Cancer Patients Undergoing Radical Prostatectomy, run by University of Guelph-Humber at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Radical prostatectomy is the most common and effective treatment for localized prostate cancer. Unfortunately, radical prostatectomy is associated with significant adverse effects, such as urinary incontinence, sexual dysfunction, and reduced physical function that collectively diminish health-related quality of life… Read more about this study

Who is it for?
Ages 40 to 80 years, men only
What is being tested?
Prehabilitation (PREHAB)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
2 sitesCanada
Study dates
Nov 2013to 17 May 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men with localized prostate cancer (stage cT1- cT2) who have consented for radical prostatectomy
  • between the ages of 40 and 80 years.

Who cannot join

  • i) severe coronary artery disease (Canadian Cardiovascular Society class III or greater);
  • ii) significant congestive heart failure (New York Heart Association class III or greater);
  • iii) uncontrolled pain;
  • iv) neurological or musculoskeletal co-morbidity inhibiting exercise;
  • v) diagnosed psychotic, addictive, or major cognitive disorders;
  • vi) no more than two of the following Coronary Risk Factors as defined by the American College of Sports Medicine : family history of coronary disease, cigarette smoking, hypertension (SBP > 140 mmHg; DBP > 90 mmHg), known dyslipidemia, known impaired fasting, glucose (>110 mg/dL), obesity (BMI > 30 kg/m2 or waist circumference > 102cm), or physically inactive (<150 min of moderate intensity physical activity per week).

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • McGill University Health Centre

    Montreal, Quebec, H3G 1A4

  • University Health Network

    Toronto, Ontario, M5G2C4

Other trials in Canada

About this study

Official title: A Multicentre, Pilot Randomized Controlled Trial to Examine the Effects of Prehabilitation on Functional Outcomes After Radical Prostatectomy

Radical prostatectomy is the most common and effective treatment for localized prostate cancer. Unfortunately, radical prostatectomy is associated with significant adverse effects, such as urinary incontinence, sexual dysfunction, and reduced physical function that collectively diminish health-related quality of life which may persist for up to two years postoperatively. The primary objective of this trial is to assess the feasibility of conducting of a multi-site randomized controlled trial to test the effect of a comprehensive prehabilitation program versus standard care for men with prostate cancer undergoing radical prostatectomy. We hypothesize that men with prostate cancer undergoing radical prostatectomy in the comprehensive prehabilitation program (full-body exercises and pelvic floor muscle exercises) will report better health-related quality of life, urological symptoms, and physical fitness, physical activity, and pain, as well as a shorter postoperative length of stay than participants receiving standard preoperative care (pelvic floor muscle exercises alone). Our secondary objective is to report estimates of efficacy on several clinically important outcomes for this population that will be used for sample size calculations in an adequately powered trial.

Being tested
Prehabilitation (PREHAB)
Keywords
Prostate cancer, Radical prostatectomy, Prehabilitation, Pelvic floor muscle exercises
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prehabilitation (PREHAB)Behavioural

Study groups in NCT02036684
Study groupRoleWhat they receive
Healthy Lifestyle BookletNo interventionStandard care for radical prostatectomy (RP) patients includes the provision of preoperative information from a urology nurse educator. Usual care (UC) participants will be given generic instructions by the research coordinator about pelvic floor muscle exercises (PFMX), mobilization and general timeframes for a return to normal activities. The UC group will receive the same PFMX prescription as the PREHAB (Experimental) group and will receive weekly communication from the research coordinator regarding compliance with the PFMX prescription to provide an attentional-control. These instructions are provided in a healthy lifestyle booklet for men with prostate cancer.
Prehabilitation (PREHAB)ExperimentalThe prehabilitation (PREHAB) program focuses on total-body physical exercises and pelvic floor muscle exercises (PFMX). The total-body exercise prescription will consist of 60 minutes of home-based, unsupervised exercise on 3-4 days per week, alternating between aerobic and resistance training. Each session will include: a 5-minute warm-up, 25 minutes of aerobic exercise, 25 minutes of resistance training (5 exercises targeting major muscle groups), and a 5-minute cool-down. Training intensity progression will occur throughout the intervention. Participants will be provided with resistance bands, a stability ball, and an exercise mat. The PFMX prescription will include a gradual increase in PFMX exercises from 60 per day during weeks 1-2, 120 per day during weeks 3-4, and 180 per day during weeks 5-6 until the surgery date. The total number of repetitions of the PFMXs will be divided equally between the rhythmic and sustained contractions.
Receives: Behavioral: Prehabilitation (PREHAB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment

    Prior exercise trials in prostate cancer patients on hormone and/or radiation therapy have observed recruitment rates of 25-40%, but no studies have assessed recruitment to a preoperative exercise intervention among prostate cancer survivors. We will measure recruitment-success percentage and will record reasons for non-participation to better understand why men electing radical prostatectomy would not participate in an exercise intervention.

    Measured: When recruitment is complete (approximately 12 months after study initiation; January 2015)

  2. Adherence to Prehabilitation Program

    Adherence to the home-based exercise program (aerobic and resistance) and pelvic floor muscle exercises will be measured through a logbook completed by the research coordinator during weekly communication.

    Measured: 26 weeks postoperatively

  3. Contamination

    The same exercise logbook questions that ask about aerobic and resistance exercise, and pelvic floor muscle exercises, will be administered to both groups to assess contamination.

    Measured: 26 weeks postoperatively

  4. Study Retention

    Retention will be assessed by measuring attrition throughout the intervention period and at each assessment.

    Measured: 26 weeks postoperatively

Secondary outcomes (6)

  1. Physical Fitness

    Musculoskeletal fitness will be assessed using grip strength (hand dynamometer) and maximal upper body strength (handheld digital dynamometer). Body composition will be assessed via body mass index, waist circumference (midpoint between lowest rib and iliac crest), and body fat percentage (bioelectrical impedance analysis). Aerobic fitness is measured using the 6-Minute Walk Test.

    Measured: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.

  2. Quality of Life

    Prostate cancer-specific health related quality of life (HRQOL) will be measured using the Functional Assessment of Cancer Treatment-Prostate (FACT-P) and the Patient-Oriented Prostate Utility Scale (PORPUS).

    Measured: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.

  3. Psychosocial Wellbeing

    Depressive symptoms will be measured with the 14-item Hospital Anxiety and Depression Scale (HADS). Cancer-specific fatigue will be measured using the FACT-Fatigue which is a widely used 13-item measure with strong reliability and validity. The Pain Disability Index (PDI) will be used to assess the extent to which persistent pain interferes with an individual's ability to engage in seven different areas of everyday activity.

    Measured: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.

  4. Physical Activity

    Physical activity level will be measured through the Community Health Activities Model Program for Seniors (CHAMPS) questionnaire. In-hospital and in-home physical activity during the acute postoperative period will be measured by the Actiwatch-64, a small wristwatch-like accelerometer device. The Actiwatch will be worn from admission to the in-patient unit until the patient returns to the hospital for catheter removal (approximately 7 days).

    Measured: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.

  5. Treatment Complications

    The number and type of peri-operative complications will be extracted from medical records.

    Measured: 26 weeks postoperatively

  6. Length of stay

    We will collect the postoperative length of stay information for all participants from the patient record.

    Measured: From time of surgery to discharge (typically 1 week)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2014 (estimated)
  2. Study startNov 2013
  3. Primary completion17 May 2016
  4. Study completion17 May 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02036684
Sponsor's protocol ID
D-201327
Status last verified
Aug 2017
First submitted
16 Nov 2013
Last updated
23 Aug 2017
Results posted
No
Data monitoring committee
No

Publications

  • Au D, Matthew AG, Lopez P, Hilton WJ, Awasthi R, Bousquet-Dion G, Ladha K, Carli F, Santa Mina D. Prehabilitation and acute postoperative physical activity in patients undergoing radical prostatectomy: a secondary analysis from an RCT. Sports Med Open. 2019 May 22;5(1):18. doi: 10.1186/s40798-019-0191-2.

    PubMed 31119491

  • Santa Mina D, Matthew AG, Hilton WJ, Au D, Awasthi R, Alibhai SM, Clarke H, Ritvo P, Trachtenberg J, Fleshner NE, Finelli A, Wijeysundera D, Aprikian A, Tanguay S, Carli F. Prehabilitation for men undergoing radical prostatectomy: a multi-centre, pilot randomized controlled trial. BMC Surg. 2014 Nov 13;14:89. doi: 10.1186/1471-2482-14-89.

    PubMed 25394949

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Prehabilitation (PREHAB) in people with Prostate Cancer Patients Undergoing Radical Prostatectomy, run by University of Guelph-Humber at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment (time frame: When recruitment is complete (approximately 12 months after study initiation; January 2015)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02036684, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.

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