EXTEND Exercise Trial

NCT02256111 | Completed Phase 2 Results

• 1 other identifier: Pro00053924
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

This study will examine the effect of supervised exercise training on cardiopulmonary function in men receiving the combination of enzalutamide (ENZ) and androgen deprivation therapy (ADT) for treatment of non-metastatic, hormone-naïve prostate cancer. No study to date has examined the efficacy, tolerability, and safety of exercise training to prevent and/or mitigate common adverse toxicities in men receiving combination androgen suppression therapy for hormone-naïve prostate cancer.

Conditions

Non-metastatic, Hormone naïve Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Change in VO2peak in Usual Care Versus Exercise Training Arms

  Mean change in peak oxygen uptake (VO2peak) from week 1 to week 17 in the usual care and exercise training groups

  From week 1 to week 17

Secondary Outcomes (14)

• 17-week Change in Functional Capacity as Measured by Chair-stand Test

  Baseline to 17 weeks

• 17-week Change in Upper and Lower Extremity Maximal Muscular Strength

  Baseline to 17 weeks

• Effects on Serum Glucose

  Baseline to 17 weeks

• Change in the Effect on Patient Reported Outcomes (PROs) of Interest Over Time

  Baseline to 17 weeks

• Eligibility Rate

  29 months from study initiation

Study Arms (2)

ENZ+ADT+Usual care

EXPERIMENTAL

The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.

Drug: Enzalutamide; Drug: Androgen deprivation therapy

ENZ+ADT+Exercise

EXPERIMENTAL

The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.

Drug: Enzalutamide; Drug: Androgen deprivation therapy; Behavioral: Supervised exercise training

Interventions

Enzalutamide DRUG

Also known as: Xtandi

ENZ+ADT+Exercise; ENZ+ADT+Usual care

Androgen deprivation therapy DRUG

ENZ+ADT+Exercise; ENZ+ADT+Usual care

Supervised exercise training BEHAVIORAL

ENZ+ADT+Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male age ≥ 18 years.
• Histologically-confirmed adenocarcinoma of the prostate.
• Completion of appropriate prior treatment with local therapy (i.e., prostatectomy, radiation therapy or equivalent), per NCCN Guidelines.
• Detectable PSA, defined as PSA ≥0.01 ng/ml
• Appropriate for treatment with ADT in the opinion of the treating physician.
• Serum total testosterone ≥150 ng/dL (5.2 nmol/L).
• ECOG performance status of ≤ 1 (Appendix A)
• Planned treatment with castration therapy (GnRH agonist/antagonist) for ≥8 months.
• Must not have any of the following absolute contraindications to cardiopulmonary exercise testing and/or aerobic training as determined by the attending oncologist:
• Absolute Contraindications
• Acute myocardial Infarction (within 3-5 days of any planned study procedures)
• Unstable angina
• Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
• Recurrent syncope
• Active endocarditis

You may not qualify if:

• Definite evidence of metastatic prostate cancer, in the opinion of the treating physician. Pelvic and retroperitoneal lymph nodes \< 2.0 cm in short axis are allowed.
• Subjects who have had treatments with GnRH agonists/antagonists and/or anti-androgens within 1 year of randomization.
• Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA values (e.g., saw palmetto) or systemic corticosteroids for prostate cancer within 4 weeks of day 29 visit (start of Enzalutamide and ADT).
• Subjects who have had radiotherapy within 12 weeks prior to entering the study or those who have not recovered from adverse events due to agents or therapies administered for treatment of prostate cancer more than 4 weeks earlier (except urinary, rectal, and sexual side effects related to prostatectomy or radiotherapy are permitted)
• Subjects who have had any surgical procedure (i.e. TURP, etc.) within 4 weeks prior to entering the study.
• Subjects who are receiving any other investigational agents.
• Significant cardiovascular disease, including:
• Symptomatic left ventricular dysfunction or known baseline left ventricular ejection fraction (LVEF) by multigated acquisition scan (MUGA) or echocardiogram (ECHO) of \< lower limit of institutional normal (LLN). "Symptomatic" is defined as New York Heart Association (NYHA) Class II or greater. Note: MUGA and ECHCO do NOT need to be measured to establish eligibility for this study.
• Uncontrolled hypertension (in the opinion of the treating provider).
• Myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of study drug.
• History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) within 12 months of first dose of study drug.
• Uncontrolled cardiac arrhythmias.
• Coronary or peripheral artery bypass graft within 6 months of first dose of study drug.
• History of CVA, TIA, or rest claudication within 6 months of first dose of study drug.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements (in the opinion of the treating provider).

Sponsors & Collaborators

• Duke University: lead

Study Sites (2)

Memorial Sloan Kettering Cancer Center

New York, New York, 10017, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Harrison MR, Davis PG, Khouri MG, Bartlett DB, Gupta RT, Armstrong AJ, McNamara MA, Zhang T, Anand M, Onyenwoke K, Edwardson S, Craig D, Michalski M, Wu Y, Oyekunle T, Coyne B, Coburn A, Jones LW, George DJ. A randomized controlled trial comparing changes in fitness with or without supervised exercise in patients initiated on enzalutamide and androgen deprivation therapy for non-metastatic castration-sensitive prostate cancer (EXTEND). Prostate Cancer Prostatic Dis. 2022 Mar;25(1):58-64. doi: 10.1038/s41391-022-00519-4. Epub 2022 Mar 10.

  PMID: 35273377 DERIVED

MeSH Terms

Interventions

enzalutamide; Androgen Antagonists

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Michael Harrison, MD
• Organization: Duke University

michael.harrison@duke.edu

919-668-4615

Study Officials

• Michael Harrison, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2014
• First Posted: October 3, 2014
• Study Start: May 13, 2015
• Primary Completion: February 21, 2018
• Study Completion: July 17, 2018
• Last Updated: April 18, 2019
• Results First Posted: April 18, 2019

Record last verified: 2019-03

Locations

US (2)