Interviews with:
Stacey A. Kenfield ScD, Epidemiologist, Professor of Urology, Epidemiology and Biostatistics, and June Chan ScD, Cancer Epidemiologist, Department of Epibiostat and Urology, University of California San Francisco, California USA.
SAN DIEGO, USA—Physical exercise keeps patients with prostate cancer alive longer, according to a combination of epidemiological and clinical study evidence emerging from research in San Francisco, California.
Intervention study findings reported at the American Association for Cancer Research (AACR) Annual Meeting in San Diego are consistent with mounting epidemiological evidence showing that regular physical exercise can help patients with advanced or metastatic prostate cancer live longer, have slower disease progression and improve their quality of life.
Stacey A. Kenfield ScD, Professor of Urology, Epidemiology and Biostatistics at the University of California San Francisco (UCSF) reported from the INTERVAL-GAP4 trial. Together with her colleague, June Chan ScD, Cancer Epidemiologist in the Department of Epibiostat and Urology at UCSF (who chaired the session on exercise for cancer patients at the AACR) she talked with the Audio Journal of Oncology about the findings and recommendations for using physical exercise as an adjunct to standard management for patients with prostate cancer.
Audio Journal of Onclogy Episode:
Stacey A. Kenfield ScD and June Chan ScD, University of California San Francisco
IN (Sarah Maxwell): There’s new evidence that exercise….. OUT: From me, Sarah Maxwell, Bye bye!” 10:28 secs
AACR ABSTRACT TITLE:
Intense exercise for survival among men with metastatic prostate cancer: 12-month feasibility results from the INTERVAL-GAP4 trial pilot site at Edith Cowan University, Australia
First Author:
Stacey A. Kenfield, UCSF – University of California San Francisco, San Francisco, CA,
Authors:
- A. Kenfield1, N. H. Hart2, J. Sison1, J. M. Chan1, K. S. Courneya3, F. Saad4, R. U. Newton5;
Institutions:
1UCSF – University of California San Francisco, San Francisco, CA, 2University of Technology Sydney, Sydney, Australia, 3University of Alberta, Edmonton, AB, Canada, 4Université de Montréal, Montréal, QC, Canada, 5Edith Cowan University, Perth, Australia
Stacey A. Kenfield, Departments of Urology and Epidemiology & Biostatistics, University of San Francisco California, San Francisco, CA
ABSTRACT
Introduction:
Men with prostate cancer undertaking moderate-to-vigorous exercise have a marked reduction of 30-60% in all-cause and cancer-related mortality based on observational studies. In 2016, the Intense Exercise for Survival among Men with Metastatic Prostate Cancer (INTERVAL-GAP4) was launched to determine if supervised exercise improves overall survival in men with metastatic prostate cancer. Here, we describe the demographic characteristics, completion rates, exercise adherence, and safety of the first 12 months of the intervention at the pilot site, Edith Cowan University in Perth, Australia.
Methods:
INTERVAL-GAP4 is a multi-center global randomized controlled phase III trial. Patients are randomly allocated (1:1) to: (intervention) a high intensity combined resistance and aerobic exercise supervised program for 1 year tapering to self-management in year 2; or (control) self-directed unsupervised exercise with print materials. Patients were stratified by site and by disease/treatment status (metastatic hormone-sensitive prostate cancer [mHSPC] or metastatic castration-resistant prostate cancer [mCRPC] and if the latter, treatment modality). The study did not meet recruitment goals and closed to further enrollment in February 2023.
Results:
240 participants were evaluated between April 2016-Feb 2023, 60 patients were consented, 52 participants were randomized, and two patients did not receive the allocation, resulting in 50 participants (27 intervention and 23 control). Main reasons for exclusion were not meeting clinical criteria (N=81), time commitment (N=24), unable to contact (N=22), not interested (N=19), and poor physical function (N=13). Median age at randomization was 72 years (IQR: 68, 77), median body mass index (BMI) was 31.7 kg/m2 (IQR: 27.5, 35.7), 94% identified as white, and time since diagnosis was 5 years (IQR: 1, 9). 13 participants (26%) had mHSPC and 37 (74%) had mCRPC. Completion rates were the following at 6 months: 84% completed surveys, 62% exercise testing, and 66% biological samples. Of 42 alive at 12 months: 85% completed surveys, 73% testing, and 73% biological samples. Median exercise adherence was 90% (IQR: 78, 97) for the first 12 months of the study. Adherence was not significantly different for those with mCRPC vs. mHSPC status. There were 10 SAEs in first 12 months; all (100%) were unrelated to the intervention.
Conclusions:
Exercise training was feasible and safe in men with metastatic prostate cancer with no difference observed in exercise session adherence by disease status. Survey completion was high, while in-person completion rates were affected by the COVID-19 pandemic. Additional analysis of the entire study population (N=145) is ongoing and will be compared with the pilot site.
ALSO:
https://ascopubs.org/doi/10.1200/GO.2023.9.Supplement_1.81
Intense exercise for survival among men with metastatic prostate cancer: 12 months feasibility results from the INTERVAL-GAP4 trial.
Background: Exercise is now considered an important therapy to ameliorate treatment side effects, improve quality of life and physical function however, causation of survival benefit and the underlying mechanisms is not yet established. In 2015, the Intense Exercise for Survival among Men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL-GAP4) – a worldwide multicentre phase III trial – was launched to determine if high-intensity combined resistance and aerobic exercise plus psychosocial support improves overall survival in men with metastatic prostate cancer. Here, while exercise delivery and follow-up assessments are still taking place in 6 different countries, we aim to examine the feasibility, exercise compliance and safety of a 12-month exercise medicine program in patients with mCRPC. Methods: Experimental design was a longitudinal analysis of attrition rates, exercise attendance and compliance metrics and programme safety over the initial 12 months of patients participating in the INTERVAL-GAP4 trial at the Edith Cowan University site in Perth, Australia. Results: 201 patients were screened for participation and 46 patients (22.9%) were randomly assigned to the two study arms. Median time since prostate cancer diagnosis was 72.0 (interquartile range (IQR): 19.5-118.5) months. Most patients were previously treated with radiotherapy (53.3%). Metastases present mostly in the lymph nodes (53.3%), followed by bones (51.1%), lungs (2.2%) and bladder (2.2%). Participants attended a total of 2,907 out of 3,744 exercise sessions scheduled, with a median exercise attendance of 78.8% (IQR: 71.6%-82.7%) per participant. Majority of sessions were performed at an RPE of 7-8 indicating “vigorous intensity” or at an RPE of 5-6 indicating “moderate intensity” (67.2%). Tolerance was moderate-to-high in most sessions (83.0%). 191 adverse events (AEs) were observed throughout the study period. A total of 136 adverse events were reported by 19 participants from the exercise group, and these were mainly disease related (n= 69, 50.7%). Most AEs were grade 1 and 2 (n= 126, 92.7%). In the control group, 55 AEs were observed, and these were mainly disease related (n= 22, 40.0%) and grade 1 and 2 (n= 51, 92.7%). The most common intervention-related adverse events experienced in the exercise group were pain (n= 6, 50.0%; i.e., back pain, bone pain, lymph node pain, and general pain). Conclusions: Patients with mCPRC can participate in high-intensity aerobic and resistance training with moderate to high attendance and tolerance. The exercise intervention appears safe with limited intervention-related adverse events experienced and mostly minor and expected. However, with only 22.9% of screened patients deemed suitable and willing, this aspect of feasibility requires attention. Clinical trial information: NCT02730338.
Robert Usher Newton: Exercise Medicine Research Institute, Edith Cowan University, Joondalup, Western Australia, Australia
Pedro Lopez
Nicolas H. Hart
Daniel Abido Galvao
Dennis R Taaffe
Timothy Dudley Clay
Charles M Ryan
Stacey A. Kenfield
Fred Saad: Division of Urology, Centre Hospitalier de l’Université de Montréal (CHUM/CRCHUM), Montreal, QC, Canada
