NCT02730338
Active, not recruiting
Not Applicable
INTense ExeRcise for SurviVAL Among Men with Metastatic Prostate Cancer (INTERVAL - GAP4): a Multicentre, Randomised, Controlled, Phase III Study
ConditionsMetastatic Prostate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metastatic Prostate Cancer
- Sponsor
- Movember Foundation
- Enrollment
- 866
- Locations
- 18
- Primary Endpoint
- Overall Survival
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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:
- •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
- •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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Overall Survival
Time Frame: up to 5 years
Overall survival will be measured from the time of randomization until death
Secondary Outcomes
- Quality of Life(up to 5 years)
- Symptomatic Skeletal Related Events (SSE)(up to 5 years)
- Physical Function(up to 5 years)
- Pain(up to 5 years)
- Opiate Use(up to 5 years)
- Analgesic Use(up to 5 years)
- Disease Progression(up to 5 years)
- Biomarker analysis(up to 5 years)
Study Sites (18)
Loading locations...
Similar Trials
Recruiting
Not Applicable
INTERVAL - Intense Exercise Trial for Men With Metastatic Castrate-Resistant Prostate CancerProstate CancerNCT04507698Guy's and St Thomas' NHS Foundation Trust80
Completed
Phase 3
INTense Exercise foR surviVAL among Men with Metastatic Prostate Cancer (INTERVAL–GAP4): A Multicenter, Randomized, Controlled Phase III StudyC61Malignant neoplasm of prostateDRKS00010310Movember Foundation149
Unknown
Not Applicable
Structured Exercise Programme and Abdominal Aortic Aneurysm SurgeryAbdominal Aortic AneurysmNCT03985202Torbay and South Devon NHS Foundation Trust60
Recruiting
Phase 3
INTense Exercise foR surVivAL among men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL - MCRPC): A Multicentre, Randomised, Controlled, Phase III Studyurologische aandoeningenprostate cancerprostate carcinomaNL-OMON47400The Movember Foundation46
Completed
Not Applicable
Effects of Intensive Aerobic and Muscle Endurance Exercise in Patients With Systemic Sclerosis - a Pilot StudySystemic SclerosisNCT01813578Karolinska University Hospital4