Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT05946993
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.
Study:
NCT05946993
Study Brief:
Protocol Section:
NCT05946993