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

Not Applicable

Active, not recruiting

• Conditions: Cancer Survivor; Prostate Carcinoma
• Interventions: Other: Educational Intervention; Other: Laboratory Biomarker Analysis; Other: Long-term Follow-up; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT03035500
• Lead Sponsor: City of Hope Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-07-23
• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-26
• Study First Posted: 2017-01-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-08-25
• Study Completion: 2025-08-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 2500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care (long-term follow-up)	Educational Intervention	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.
Supportive Care (long-term follow-up)	Laboratory Biomarker Analysis	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.
Supportive Care (long-term follow-up)	Long-term Follow-up	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.
Supportive Care (long-term follow-up)	Quality-of-Life Assessment	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.
Supportive Care (long-term follow-up)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
HRQL assessed using Sexual Health Inventory for Men	Up to 10 years	Linear mixed effects models can be used to estimate long-term trends and examine the effects of baseline and concomitant factors on these trends.
HRQL assessed using Expanded Prostate Cancer Index Composite	Up to 10 years	Linear mixed effects models can be used to estimate long-term trends and examine the effects of baseline and concomitant factors on these trends.
Incidence rates of the study end-points	Up to 10 years	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.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States