Overview
To evaluate the feasibility of introducing a men's cancer survivorship programme into routine follow up care in patients with advanced genitourinary malignancies.
Description
Study design: Sequential Cohorts/ Parallel Sampling Groups Specific Aim: To assess the feasibility of a comprehensive multidisciplinary interventional programme for men living with advanced/metastatic genitourinary cancers Sample size: 72
Entry criteria: Advanced / metastatic genitourinary cancer (including prostate, kidney, urothelial tract, testicular and/or penile cancers), provided they meet the following
- conditions
-
- Prostate cancer - Histologically confirmed prostate cancer and 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.
- Urothelial tract cancer - Stage II - IV urothelial tract cancer after completion of primary treatment with systemic therapy
- Kidney cancer - Stage II - III renal cell cancer
- Testicular cancer - Stage II - III testicular cancer after completion of primary treatment
- Penile cancer - • Stage III - IV penile cancer after completion of primary treatment with systemic therapy
- Currently on active surveillance (i.e. no active systemic therapies at present) or continuing on maintenance systemic therapy, provided they do not have ongoing adverse events which will impact their participation at the time of commencing the 12-week intervention.
- Note: Men with resected disease (adjuvant setting) are eligible if they have commenced or completed adjuvant systemic therapy within the past 12 months and have recovered from these treatments at the time of commencing the 12-week programme from ongoing systemic therapy.
Eligibility
Inclusion Criteria:
- Men aged ≥ 18 years of age at the time of study enrolment.
- Willing to participate in a 12-week intervention programme and follow up procedures as outlined in the Schedule of Activities section.
- ECOG performance status 0-2.
- 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.
- 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.