Standardized Resistance Training Program and Assessment System for Prostate Cancer Patients Receiving Androgen Deprivation Therapy ISPoRT-PCa-ADT Study Protocol for a Randomized Controlled Trial. SPORT-MU

Overview

This randomized controlled trial (RCT) with two parallel study arms evaluated the effectiveness of a 24-week exercise intervention in prostate cancer (PCa) patients under-going androgen deprivation therapy (ADT). Ethical approval was obtained from the Clinical Research Ethics Committee of the University Clinical Hospital "Virgen de la Arrixaca" (Murcia, Spain). Participants were randomly assigned to one of two groups: (1) a supervised progressive resistance training program (SPoRT-PCa-ADT), or (2) a control group receiving a home-based exercise protocol following an initial assessment, accom-panied by weekly telephone follow-up. Assessments were conducted at baseline and at 24 weeks to examine changes in physical, functional, and psychosocial outcomes. Addi-tionally, patient-reported outcomes were collected at the 12-week midpoint (Figure 1). This study design enabled the evaluation of both immediate and sustained intervention effects and facilitated a direct comparison between supervised and home-based exercise approaches

Detailed description

This randomized controlled trial (RCT) with two parallel study arms evaluated the effectiveness of a 24-week exercise intervention in prostate cancer (PCa) patients under-going androgen deprivation therapy (ADT). Ethical approval was obtained from the Clinical Research Ethics Committee of the University Clinical Hospital "Virgen de la Arrixaca" (Murcia, Spain). Participants were randomly assigned to one of two groups: (1) a supervised progressive resistance training program (SPoRT-PCa-ADT), or (2) a control group receiving a home-based exercise protocol following an initial assessment, accom-panied by weekly telephone follow-up. Assessments were conducted at baseline and at 24 weeks to examine changes in physical, functional, and psychosocial outcomes. Addi-tionally, patient-reported outcomes were collected at the 12-week midpoint (Figure 1). This study design enabled the evaluation of both immediate and sustained intervention effects and facilitated a direct comparison between supervised and home-based exercise approaches

Interventions

• Procedure Exercise Intervention Protocol
  Subjects participated in the supervised exercise program twice weekly (with a 48-72-hour interval between sessions) for 24 weeks, totaling 48 supervised sessions. The progressive resistance training program used velocity-based training principles \[24-26\], a novel approach in exercise oncology that allows for precise load management and indi-vidualization based on daily performance capacity
• Procedure SPoRT-Control Intervention
  structured written instructions for a personalized home-based resistance training program. The protocol was designed to prioritize safety, progressive adaptation, and individualization based on each participant's functional capacity and available resources at home. The program was intended to be performed two to three times per week on non-consecutive days, focusing exclusively on lower-body training through a single primary movement. Each session consisted of three effective sets of 12 repetiti

Primary outcome measures

• Progressive loading test [Time frame: Up for a 24 weeks]
• Vertical jump test [Time frame: up for 24 weeks]
• Maximum Isometric Contraction Test [Time frame: up for 24 weeks]
• Fatigue assessment [Time frame: Up for 24 weeks]
• Quality of Life Assessment [Time frame: Up for a 24 weeks]
• Psychological Distress [Time frame: Up for 24 weeks]
• Urinary Function [Time frame: Up for a 24 weeks]
• Sleep Quality [Time frame: Up for a 24 weeks]

Eligibility criteria

Inclusion criteria

• diagnosis of locally advanced or metastatic prostate neoplasm and current treatment with androgen deprivation therapy (ADT)
• treatment at the radiotherapy oncology department of University Clinical Hospital "Virgen de la Arrixaca"
• legal adult age with signed informed consent

Exclusion criteria

• unwillingness to participate in the study
• inability to complete adequate follow-up due to any cause that would prevent knowledge of patient evolution during the follow-up period
• no controlled or symptomatic metastatic bone disease
• physical disabilities that would prevent participants from safely completing the exercise protocol

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 1 center

• HCUVA — Murcia

Publications

• Soler-Lopez A, Gomez-Carmona CD, Gonzalez-Devesa D, Lopez-Plaza D, Herrero-Vidal L, Toledo-Pozuelo R, Gonzalez-Costea A, Cao-Avellaneda E. Standardized Program of Resistance Training for Prostate Cancer Patients Receiving Androgen Deprivation Therapy (SPoRT-PCa-ADT): study protocol for a randomized controlled trial. BMC Cancer. 2026 Apr 22;26(1):711. doi: 10.1186/s12885-026-15902-w. PMID 42015017

Identifiers

NCT: NCT07064811 · SPORT-MU

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗