Long-Term Follow-Up in Patients With Prostate Cancer After Surgery

Prostate Carcinoma Clinical Trial

Official title:

Long-term Follow-up After Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03035500
• Other study ID #: 07101
• Secondary ID: NCI-2017-0009007
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 23, 2008
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial studies how well a long-term follow-up works in patients with prostate cancer after surgery. Long-term follow-up data may serve as a resource to help ask clinical questions, describe health-related quality of life and long-term complications related, and facilitate future studies focusing on interventions to improve health status and health-related quality of life in prostate cancer survivors.

Description:

PRIMARY OBJECTIVES:

I. To provide comprehensive long-term follow-up care to prostate cancer survivors at the City of Hope who underwent definitive surgical therapy.

II. To use the information obtained from follow-up of prostate cancer survivors who underwent definitive surgical therapy to serve as a resource that will help answer clinical questions, generate and test hypotheses, describe the incidence of long-term complications, and facilitate future studies focusing on interventions for long-term complications of prostate cancer and its therapy.

III. To use the information gained from follow-up of prostate cancer survivors who underwent definitive surgical therapy to describe health-related quality of life (HRQL) concerns and to serve as a resource to facilitate future studies focusing on interventions to improve health status and HRQL in prostate cancer survivors.

OUTLINE:

Patients undergo long-term follow-up and receive a written survivorship care plan including comprehensive health evaluation and health education beginning 1 year post surgery.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2500
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of prostate cancer

• Treated with a definitive surgical procedure at City of Hope

• At least one year post surgical treatment for prostate cancer

• No history of recurrent, progressive, or metastatic disease

• Currently stable disease or no evidence of disease

• No prior treatment of prostate cancer with radiation or chemotherapy

• No history of other urologic cancer (e.g., bladder cancer, renal cell carcinoma) in addition to prostate cancer

• Note: Patients who develop recurrence while participating in the Prostate Cancer Survivorship Clinic will be referred back to their urologist and may resume participation in the Survivorship Clinic when deemed appropriate by their treating physician

Exclusion Criteria:

• Current treatment with testosterone replacement or androgen deprivation therapy

• Treatment for another noncutaneous cancer within the past 2 years

Related Conditions & MeSH terms

• Cancer Survivor
• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Other:
• Educational Intervention
Receive health education
• Laboratory Biomarker Analysis
Correlative studies
• Long-term Follow-up
Undergo long-term follow-up using survivorship care plan
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HRQL assessed using Expanded Prostate Cancer Index Composite	Linear mixed effects models can be used to estimate long-term trends and examine the effects of baseline and concomitant factors on these trends.	Up to 10 years
Primary	HRQL assessed using Sexual Health Inventory for Men	Linear mixed effects models can be used to estimate long-term trends and examine the effects of baseline and concomitant factors on these trends.	Up to 10 years
Primary	Incidence rates of the study end-points	Incidence rates of the study end-points that may be associated with original diagnosis or treatment received, and delineation of temporal changes in serial measurements and their relationship to time-invariant characteristics such as original diagnosis, race, and education and time-varying characteristics such as age and body mass index will be estimated. Incidence rates may be compared with national standards adjusted for key demographic variables and between patient subgroups.	Up to 10 years