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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02730338




Registration number
NCT02730338
Ethics application status
Date submitted
10/03/2016
Date registered
6/04/2016
Date last updated
15/03/2023

Titles & IDs
Public title
INTense ExeRcise for surviVAL Among Men With Metastatic Prostate Cancer (INTERVAL - GAP4)
Scientific title
INTense ExeRcise for surviVAL Among Men With Metastatic Prostate Cancer (INTERVAL - GAP4): A Multicentre, Randomised, Controlled, Phase III Study
Secondary ID [1] 0 0
GAP4
Universal Trial Number (UTN)
Trial acronym
INTERVAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - High intensity aerobic and resistance training
Behaviour - Psychosocial support

Active Comparator: Arm A: Supervised exercise group - Supervised high intensity aerobic and resistance exercise tapering to self management with psychosocial support

Other: Arm B: Self directed exercise group - Self directed exercise and psychosocial support group


Behaviour: High intensity aerobic and resistance training


Behaviour: Psychosocial support
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
up to 5 years
Secondary outcome [1] 0 0
Disease Progression
Timepoint [1] 0 0
up to 5 years
Secondary outcome [2] 0 0
Symptomatic Skeletal Related Events (SSE)
Timepoint [2] 0 0
up to 5 years
Secondary outcome [3] 0 0
Opiate Use
Timepoint [3] 0 0
up to 5 years
Secondary outcome [4] 0 0
Analgesic Use
Timepoint [4] 0 0
up to 5 years
Secondary outcome [5] 0 0
Biomarker analysis
Timepoint [5] 0 0
up to 5 years
Secondary outcome [6] 0 0
Biomarker analysis
Timepoint [6] 0 0
up to 5 years
Secondary outcome [7] 0 0
Biomarker analysis
Timepoint [7] 0 0
up to 5 years
Secondary outcome [8] 0 0
Quality of Life
Timepoint [8] 0 0
up to 5 years
Secondary outcome [9] 0 0
Physical Function
Timepoint [9] 0 0
up to 5 years
Secondary outcome [10] 0 0
Pain
Timepoint [10] 0 0
up to 5 years

Eligibility
Key inclusion criteria
mCRPC status:

- mCRPC patients defined as; adenocarcinoma of the prostate with systemic metastatic
disease despite castrate levels of testosterone (<50 ng/dL) due to orchiectomy or LHRH
agonist.

o Patients must have one or more of the following to be considered mCRPC

- Metastatic Disease Progression: >20% increase in the sum of diameters of measurable
lesions from the time of maximal regression or appearance of one or more new lesions.

- Bone Scan Progression: Appearance of one or more new lesions on bone scan attributable
to prostate cancer.

- PSA Progression: PSA =2 ng/ml that has risen serially on at least two occasions, each
at least one week apart (PSA1 < PSA2 < PSA3).

- PSMA PET/CT scan progression: Appearance of one or more new lesions on PSMA PET/CT
scan attributable to prostate cancer.

- At enrolment, mCRPC patients must fit into one of the following 5 categories:

1. Treatment naïve for mCRPC (have not yet started approved therapies for CRPC ie:
Abiraterone/Enzalutamide/Apalutamide / or Docetaxel, Cabazitaxel or other
approved first line chemotherapy; less than 4 weeks on approved therapies is
still considered to be treatment naïve) Or

2. Receiving Abi/Enza/Apa for mCRPC AND responding or stable (PSA values must be
stable or declining after at least 4 weeks since starting Abi/Enza/Apa for mCRPC)
Or

3. Patients with PSA progression while on Abi/Enza/Apa are eligible as long as they
are asymptomatic AND there is no intent on starting chemotherapy within 6 months
Or

4. Patients treated with Docetaxel, Cabazitaxel or other approved first line
chemotherapy as first line for mCRPC who are asymptomatic without ANY evidence of
progression Or

5. Patients may have progressed following first line Docetaxel, Cabazitaxel or other
first line chemotherapy and are now receiving treatment with Abi/Enza/Apa. These
patients must absolutely be responding or stable (PSA values must be stable or
declining after starting Abi/Enza/Apa treatment) and have an estimated life
expectancy of more than 1 year.

mHSPC Status:

- mHSPC patients must be classified as either high-risk or high-volume mHSPC. These
groups are defined as adenocarcinoma of the prostate with systemic metastatic disease
and patients also fit into one of the following 2 categories: 6. High-risk: defined as
having at least 2 of three criteria: (i) Gleason score =8, (ii) presence of =3 lesions
on bone scan, or (iii) presence of INTERVAL Protocol Version 5.0, 19 August 2019 4
measurable visceral lesions (PSMA PET imaging should not be used in the definition of
high-risk disease) Or 7. High-volume: defined as having the presence of visceral
metastases and/or = four bone metastases with at least one outside of the vertebral
column and pelvis (PSMA PET imaging should not be used in the definition of
high-volume disease)

Additional criteria for all groups:

- All patients will be required to be on ADT during the study period or have had a prior
bilateral orchiectomy.

- Men with small cell neuroendocrine tumours or features of small cell disease are not
eligible.

- =4 weeks since last major surgery and fully recovered.

- No known contraindications to high intensity exercise, including, but not limited to:
brain metastases; current congestive heart failure (New York Heart Association Class
II, III or IV); serious or non-healing wound, ulcer, or bone fracture; spinal cord
compromise or instrumentation due to metastatic disease; peripheral neuropathy =grade
3. No serious cardiovascular events within 12 months including, but not limited to,
transient ischemic attack (TIA), cerebrovascular accident (CVA), or myocardial
infarction (MI). Patients with a history of hypertension must be well-controlled (<
160/90) on anti-hypertensive therapy.

- Halabi Nomogram score <1951 (Risk Category rated as low or intermediate risk)

- Age =18 years

- Required Baseline Laboratory Values: ANC = 1500/uL; Platelet count = 100,000/uL;
Creatinine = 1.5 x upper limits of normal; Bilirubin = 1.5 x upper limits of normal;
AST = 1.5 x upper limits of normal; Serum testosterone = 50 ng/dL

- ECOG performance status 0-1

- Medical clearance by treating physician to undergo a symptom-limited cardiopulmonary
exercise test and vigorous aerobic and resistance exercise training, and able to
complete an acceptable cardiopulmonary exercise test.

- Exercise Coordination Centre (ECC) review and approval of subject's screening bone
scan / areas with bone metastases.

- Men participating in vigorous aerobic exercise for >60 min/week or structured
resistance exercise =2 days/week, are not eligible.

- Subject is willing and able to use technological aspects of the trial.

- The subject is fluent in the language as designated by the institution at which he
would be enrolled.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2028
Actual
Sample size
Target
866
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
University of Canberra - Canberra
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Sydney
Recruitment hospital [3] 0 0
Australian Prostate Cncr Research Centre - Brisbane
Recruitment hospital [4] 0 0
University of Queensland - Brisbane
Recruitment hospital [5] 0 0
Victoria University / Sunshine Hospital - Melbourne
Recruitment hospital [6] 0 0
Edith Cowan University - Perth
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington
Country [6] 0 0
Canada
State/province [6] 0 0
Alberta
Country [7] 0 0
Canada
State/province [7] 0 0
Nova Scotia
Country [8] 0 0
Canada
State/province [8] 0 0
Montreal
Country [9] 0 0
Germany
State/province [9] 0 0
Cologne
Country [10] 0 0
Ireland
State/province [10] 0 0
Dublin
Country [11] 0 0
Netherlands
State/province [11] 0 0
Rotterdam
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Surrey
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Belfast
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Glasgow
Country [15] 0 0
United Kingdom
State/province [15] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Movember Foundation
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of California, San Francisco
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Edith Cowan University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
King's College London
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Centre hospitalier de l'Université de Montréal (CHUM)
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
To determine if supervised high intensity aerobic and resistance training increases overall
survival compared to self-directed exercise in patients with metastatic prostate cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02730338
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Newton
Address 0 0
Edith Cowan University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02730338