Phase 2 Prostate Cancer Trial, Recruiting NCT07001241 Sponsor: University of Colorado, Denver Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT07001241
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 to 89 years old
  • People who have been diagnosed with breast cancer or prostate cancer
  • People who finished cancer treatment aimed at curing the cancer more than 3 months ago but less than 5 years ago
  • Treatment must have included hormone therapy, radiation, chemotherapy, and/or immunotherapy — treatment by surgery alone does not meet this criterion
  • People with breast cancer who are currently on ongoing hormone therapy, with no planned changes to that treatment in the next six months, may also meet this criterion
  • People whose home address falls within an area defined as rural by the Health Resources & Services Administration (HRSA) (confirm with trial site using data.hrsa.gov/tools/rural-health)
  • People experiencing at least moderate fatigue, rated above 3 out of 10 using National Comprehensive Cancer Network guidelines
  • People with access to high-speed internet at home
  • People who own a smartphone or laptop with a front-facing camera
  • People who are able and willing to give informed consent to take part
  • People willing to take part in a 12-week online exercise program, or a 12-week waiting period before the program, including brief remote physical check-ins and small blood sample collections (dried blood spots) every 2 weeks
  • People able and willing to provide contact details for a local support person who could help if any unexpected health concerns arise
  • People able and willing to provide contact details for a local primary care doctor who could address any medical issues that come up during the study
  • People able to provide a signed clearance from a doctor for exercise, if this is flagged as needed by a standard physical activity safety questionnaire (PAR-Q+ or NCCN exercise safety screening)

Who may not be able to join:

  • People whose general physical functioning is significantly limited, as measured by a standard medical scale called the ECOG Performance Status (a score of 2 or higher on this scale)
  • People who are currently receiving, or plan to receive, cancer treatments in the next six months — except for ongoing maintenance hormone therapy
  • People with prostate cancer who are currently receiving, or have previously received 12 months or more of, a hormone-suppressing treatment called androgen deprivation therapy (ADT)
  • People who plan to move to a non-rural area within the next six months
  • People with a health condition that may make it unsafe to take part in an exercise program, such as a recent heart event or a chronic lung condition — these conditions are identified through the PAR-Q+ questionnaire (confirm with trial site)
  • People with a current or past metabolic disease, such as diabetes or uncontrolled thyroid conditions — however, people with pre-diabetes, metabolic syndrome, or diabetes managed with metformin only may still meet eligibility criteria, with this noted for research analysis
  • People who are currently taking part in another exercise program designed for cancer patients

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Ryan J Marker, PhD, DPT, University of Colorado, Denver

Phone: 720-724-9601

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
8 October 2025
Est. completion
1 August 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change from Baseline in FACIT-Fatigue (cancer-related fatigue) score at Week 12

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov