Can a Men's cancer support program fit into routine care?
NCT ID NCT05946993
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a 12-week survivorship program for men with advanced prostate, kidney, bladder, testicular, or penile cancer can be successfully added to their regular follow-up care. Researchers will measure how feasible and acceptable the program is using questionnaires. The goal is to understand if this kind of support is practical and helpful for men living with metastatic cancer.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Men aged ≥ 18 years of age at the time of study enrolment. 2. Willing to participate in a 12-week intervention programme and follow up procedures as outlined in the Schedule of Activities section. 3. ECOG performance status 0-2. 4. Recovery to CTCAE Grade ≤2 adverse events from all prior therapies, or adequately recovered adverse events whereby, whereby the PI feels they will not impact the participants ability to complete the 12-week intervention. 5. Disease-specific inclusion criteria: Prostate cancer: * Histologically confirmed prostate cancer * Must have commenced Androgen Deprivation Therapy (ADT) in the form of a gonadotropin-releasing hormone (GnRH) analogue or a GnRH receptor antagonist and/or an androgen receptor antagonist and/or undergone bilateral orchidectomy for prostate cancer. Men must have received last ADT treatment within 12 months of starting the programme or have ongoing treatment-related side effects at the time of commencing the programme if ADT has been discontinued due to toxicity. * Patients without histologically confirmed cancer are eligible if both the treating physician and the study PI agree that the patient's history is unambiguously indicative of advanced prostate cancer (e.g. high Prostate-specific antigen (PSA) responsive to ADT in prostate cancer). Urothelial tract cancer: * Stage II - IV urothelial tract cancer (muscle-invasive, node positive or metastatic disease) after completion of primary treatment with systemic therapy (including in the neoadjuvant or adjuvant setting) and/or surgery and recovery from these treatments to a satisfactory level. * Patients with metastatic disease continuing on maintenance systemic therapy are permitted if they do not have ongoing CTCAE Grade \>2 adverse events which will impact their participation at the time of commencing the 12-week programme. Kidney cancer: • Stage II - III renal cell cancer (clear cell or non-clear cell histologies permitted) after nephrectomy who required and have commenced or completed adjuvant systemic therapy within the past 12 months and have recovered from these treatments to CTCAE Grade ≤2 or do not have ongoing CTCAE Grade \>2 adverse events at the time of commencing the 12-week programme from ongoing systemic therapy. Or • Stage IV renal cell cancer (clear cell or non-clear cell histologies permitted) where the participants are continuing on stable dose of maintenance systemic therapy and do not have ongoing CTCAE Grade \>2 adverse events at the time of commencing the 12-week programme. Testicular cancer: • Stage II-III testicular cancer after completion of primary treatment with systemic therapy and/or surgery within the past 12 months and recovery of all adverse events from these treatments to CTCAE Grade ≤2. Penile Cancer: * Stage III - IV penile cancer (node positive, recurrent or metastatic disease) after completion of primary treatment with systemic therapy (including in the neoadjuvant or adjuvant setting) and/or surgery and recovery from these treatments to CTCAE Grade ≤2. * Patients with metastatic disease continuing maintenance systemic therapy are permitted if they do not have ongoing CTCAE Grade \>2 adverse events which will impact their participation at the time of commencing the 12-week programme. 6. Participation in other translational or interventional clinical trials is permitted provided the above disease-specific inclusion criteria are met. 7. Signed consent form by the participant or a legally authorized representative (LAR). Exclusion Criteria: 1. Persons who, in the opinion of the researcher or supervising clinician, are unable to cooperate adequately with the study protocol, for example those receiving systemic therapy for a concurrent cancer diagnosis, those with organ system dysfunction which would impact their safe participation in the study, or other uncontrolled medical illness that would impact their safe participation in the study. 2. Recent (within 12 months) participation in a study/programme involving a lifestyle intervention (e.g diet, exercise, survivorship). 1. Note: Per discretion of PI as to whether may impact the outcome of this study intervention.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cork University Hospital
Cork, Cork, T12 DC4A, Ireland
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Other studies related to the condition(s) this trial covers.
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