Support program for men with advanced genitourinary cancers

Linking In With Advice and Supports for Men Impacted by Metastatic Cancer

This study is testing a support program that offers various types of care for men with advanced genitourinary cancers to see how well it can be included in their regular follow-up treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: University College Cork (Academic / other)
• Locations: 1 site (Cork)
• Trial ID: NCT05946993 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility of a comprehensive survivorship program designed for men with advanced or metastatic genitourinary cancers, including prostate, kidney, urothelial tract, and testicular cancers. The program includes multidisciplinary interventions such as physiotherapy, dietitian support, nursing, and psychosocial care over a 12-week period. The study aims to assess how well this program can be integrated into routine follow-up care for these patients, with a sample size of 72 participants.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 and older with advanced or metastatic genitourinary cancers who are willing to participate in a 12-week intervention.

Not a fit: Patients with severe ongoing adverse events from previous therapies that would impact their ability to participate may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve the quality of life and survivorship outcomes for men affected by advanced genitourinary cancers.

How similar studies have performed: Other studies have shown promise in similar multidisciplinary approaches for cancer survivorship, suggesting potential for success in this program.

Eligibility criteria

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.

Where this trial is running

Cork

• Cork University Hospital — Cork, Ireland (Recruiting)

Study contacts

• Principal investigator: Jack Gleeson, MB — Cork University Hospital
• Study coordinator: Jack Gleeson, MB

Conditions Survivorship; Prostate Cancer; Kidney Cancer; Urothelial Tract/Bladder Cancer, Nos; Testicular Cancer; Penile Cancer; cancer; prostate