Is Exercise During Androgen Deprivation Therapy Effective and Safe? A Randomized Controlled Trial

Abstract

To explore the benefits and safety of supervised and unsupervised exercise among localized and metastatic prostate cancer patients (PCa) during long-term androgen deprivation therapy (ADT). A total of 44 PCa patients were enrolled in this randomized controlled trial (RCT). Participants were randomized in a 1:1 ratio into the supervised exercise sessions group or unsupervised home-based exercise group for three months. The primary outcomes assessed included quality of life (QoL), body composition, and metabolic markers, which were measured at baseline, after 3 months, and 6 months. Muscle strength was evaluated exclusively in the supervised exercise group. The main statistical models used were the Mann-Whitney U-test for between-group comparisons and the Wilcoxon rank-sum test for within-group changes. No adverse events were reported during the exercise period. There were no significant differences in QoL, body composition, or metabolic profiles between the intervention and control groups. The supervised exercise group demonstrated significant improvement in emotional functioning (Z = -2.102, p = 0.036), and all exercise performance metrics (p < 0.001), with the most pronounced gains observed in the leg press (Z = -4.17, p < 0.001). Furthermore, a significant association was identified between strength improvements and enhanced self-evaluated physical function (p < 0.001). Supervised exercise is safe for patients with localized and metastatic PCa undergoing ADT, and leads to significant improvements in emotional well-being, and muscle strength, which translates to better self-reported physical function. Findings underscore the need for RCTs with longer intervention and follow-up periods on supervised exercise, especially in metastatic PCa patients.

Key points Supervised exercise was safe for patients with localized and metastatic prostate cancer who were undergoing long-term androgen deprivation therapy.

The supervised exercise among both localized and metastatic prostate cancer patients seems to result in improvements in diverse performance and strength-related metrics.

Competing Interest Statement

TJ Murtola: Lecture fees from Astellas, Amgen, Janssen, Novartis and Sanofi, paid consultant for Astellas, AstraZeneca, Johnson & Johnson, Pfizer and Accord, clinical trial funding from Bayer, Pfizer and Janssen. J Sormunen: Lecture fees Johnson & Johnson, Accord.

Clinical Trial

NCT04050397

Funding Statement

I Jussila was funded by the State Research Funding for university-level health research, Kuopio University Hospital, Wellbeing Service County of North Savo, Orion Research Funding, Paulon Foundation, Scandinavian Prostate Cancer Group, and JYU.WELL.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This study was registered at ClinicalTrials.gov under the identifier #NCT04050397 prior to the initiation of participant recruitment. Ethical approval for this trial was obtained from the Tampere University Hospital Ethics Board.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Footnotes

# shared first authorship between first two authors

lauri.rantaniemituni.fi, aino.siltarituni.fi, juha.ahtiainenjyu.fi, annastiina.hakulinentuni.fi, eeva.harjutuni.fi, jorma.sormunenfimnet.fi, tupu.nordstromvarala.fi, teuvo.tammelatuni.fi, teemu.murtolatuni.fi

Data Availability

Due to the high profile, and sensitive nature of the participants in this study, data cannot be shared according to the national laws in Finland.

Abbreviations used in the articleADTAndrogen Deprivation TherapyPCaProstate CancerQoLQuality of LifeEORTC QLQ-C30European Organisation for Research and Treatment of Cancer Quality of Life QuestionnairePR25Prostate Cancer-Specific Quality of Life ModuleECOGEastern Cooperative Oncology Group Performance StatusGEEGeneralized Estimating EquationsIQRInterquartile RangePSAProstate-Specific AntigenISUPInternational Society of Urological PathologyGnRHGonadotropin-Releasing HormoneHbA1CGlycated HemoglobinLDLLow-Density LipoproteinHDLHigh-Density LipoproteinBMIBody Mass IndexEORTC QLQ-30Main Quality of Life Section of the QuestionnairePRSFUSexual FunctioningPRSACSexual ActivityPRURIUrinary SymptomsPRBOWBowel SymptomsPRHTRHormonal Treatment-Related SymptomsPRAIDIncontinence Aid Use

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