Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-02 @ 10:18 AM
Study NCT ID:
NCT05946993
Status:
RECRUITING
Last Update Posted:
2025-06-25
First Post:
2023-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Linking In With Advice and Supports for Men Impacted by Metastatic Cancer
Sponsor:
University College Cork
Organization:
Study Overview
Official Title:
Linking In With Advice and Supports for Men Impacted by Metastatic Cancer
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIAM Mc
Brief Summary:
To evaluate the feasibility of introducing a men's cancer survivorship programme into routine follow up care in patients with advanced genitourinary malignancies.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: