INTERVAL - Intense Exercise Trial for Men With Metastatic Castrate-Resistant Prostate Cancer

NCT04507698 | Unknown DMC

• 1 other identifier: 201101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief Summary

Exercise has been established to be safe and result in improved physical function and quality of life for most individuals with cancer. However, little information exists regarding whether exercise can increase overall survival and reduce disease progression, events related to cancer spreading to the bones (e.g. bone fracture, spinal cord compression, extra radiation or surgery), and pain in patients with metastatic prostate cancer that is no longer responding to hormone therapy. The primary objective of this study is to determine if high intensity aerobic and resistance training plus psychosocial support increases overall survival compared to psychosocial support alone in prostate cancer patients. The Movember foundation is providing support for the conduct of this study

Conditions

Prostate Cancer

Keywords

Metastatic; Castrate; Prostate; Cancer; Resistant

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Patients will be followed for death a minimum of 36 months after randomisation. Overall survival will be measured from the time of randomisation until death. Medical records and death certificates will be reviewed every 6 months to obtain survival status. Country-specific mortality status databases will also be searched annually; cause of death will be determined through review of medical and death records. Patients will be contacted once a year, and follow up with next of kin then alternate contact, if needed, if we do not hear from them.

  24 months

Secondary Outcomes (6)

• Disease progression

  24 months

• Symptomatic Skeletal Related Events

  24 months

• Analgesic/Opiate Use

  24 months

• Metabolic Biomarkers

  24 months

• Physical Function

  24 months

Study Arms (2)

Supervised Exercise Arm

EXPERIMENTAL

If participants are placed in the Supervised Exercise Group, they will attend supervised group exercise sessions, which are individually tailored to the participants physical condition, at least once a week, every week for the first year of the study. They will be asked to exercise 3 times a week.

Other: Intensive Exercise Intervention

Self-Directed Exercise Arm

NO INTERVENTION

If Participants are placed in the Self-directed Exercise Group, they will receive usual medical care (standard of care) and be asked to follow their usual exercise and lifestyle routine. They will receive supportive care in the form of newsletters, covering a variety of topics including pain management, bone health, goal setting, taking control of life, and more.

Interventions

Intensive Exercise Intervention OTHER

INTense Exercise foR surVivAL among Men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL - MCRPC), randomised to either the supervised exercise arm or the self-directed exercise arm.

Supervised Exercise Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male prostate cancer patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be mCRPC. This is defined as adenocarcinoma of the prostate with systemic metastatic disease despite castrate levels of testosterone (\<50 ng/dL) due to orchiectomy or LHRH agonist.
• 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).
• Castrate levels of testosterone must be maintained while on study. Be on androgen deprivation therapy (ADT) with a GnRH agonist/antagonist or prior bilateral orchiectomy. 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.
• At enrolment, patients must fit into one of the following 5 categories:
• Treatment naïve for mCRPC (have not yet started approved therapies for CRPC i.e.: Abiraterone/Enzalutamide/Apalutamide/Docetaxel; 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
• 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
• Patients treated with Docetaxel as first line therapy for mCRPC who are asymptomatic without ANY evidence of progression Or
• Patients may have progressed following Docetaxel first line 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 expected life expectancy of more than 1 year.
• 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 INTERVAL Protocol Version 4.0, 19 April 2018 4
• ≥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.

You may not qualify if:

• Previous radiographic or clinical progression (PSA progression is permitted) while on treatment with abiraterone, enzalutamide, apalutamide, or a combination.
• Previously identified small cell neuroendocrine tumours or pure small cell carcinoma of the prostate, based on a prior biopsy of the prostate.
• Brain metastases (brain imaging is not required)
• Previous and/or concurrent treatment with other anti-cancer treatments is permitted. Patients are allowed to be treated with chemotherapy during the duration of the trial. Patients who have received chemotherapy as part of initial androgen deprivation therapy for metastatic castration sensitive disease are eligible.
• Currently receiving experimental treatment with non-approved drugs at the time of enrolment. Patients must undergo a 28-day washout between last dose and screening CPET.
• Poorly controlled hypertension. During screening ≥2/3 of readings must be \< 160/90, regardless of whether on a regimen of anti-hypertensive therapy or not.
• If patient is currently taking hypertensive medication(s)/therapy, please indicate medication and include in the Treatment and Concomitant Medications Log (SOM: Appendix 11).
• Current congestive heart failure (New York Heart Association Class II, III or IV)
• Recent serious cardiovascular events (within 12 months) including, but not limited to, transient ischemic attack (TIA), cerebrovascular accident (CVA), or myocardial infarction (MI).
• Medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the physician, would make this protocol unreasonably hazardous for the patient.
• Patients with a currently active second malignancy other than non-melanoma skin cancer. Patients are not considered to have a currently active malignancy if they have completed necessary therapy and are considered by their physician to be at \<30% risk of relapse at time of assessment.
• Psychiatric illness, which would prevent the patient from giving informed consent or adhering to the study protocol.
• Serious or non-healing wound, ulcer, or bone fracture.
• Known spinal cord compromise or instrumentation due to metastatic disease in the mCRPC state. Radiation therapy for metastatic disease is allowed.
• Peripheral neuropathy ≥grade 3.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• Movember Foundation: collaborator
• Queen's University, Belfast: collaborator
• University of Glasgow: collaborator
• University of Bristol: collaborator
• University of Surrey: collaborator

Study Sites (4)

Queens University Belfast

Belfast, Northern Ireland, United Kingdom

RECRUITING

University of Glasgow

Glasgow, United Kingdom

RECRUITING

Guy's and St Thomas's NHS Trust

London, SE1 9RT, United Kingdom

RECRUITING

University of Surrey

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Harriet Wylie

CONTACT

07464492509; harriet.wylie@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: August 11, 2020
• Study Start: September 1, 2017
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2024
• Last Updated: August 11, 2020

Record last verified: 2020-08

Locations

GB (4)