search
Back to results

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

Primary Purpose

Cancer Survivor, Prostate Carcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Laboratory Biomarker Analysis
Long-term Follow-up
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Survivor

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive Care (long-term follow-up)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 25, 2017
Last Updated
August 3, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT03035500
Brief Title
Long-Term Follow-Up in Patients With Prostate Cancer After Surgery
Official Title
Long-term Follow-up After Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 23, 2008 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Survivor, Prostate Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supportive Care (long-term follow-up)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Receive health education
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Long-term Follow-up
Intervention Description
Undergo long-term follow-up using survivorship care plan
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
HRQL assessed using Expanded Prostate Cancer Index Composite
Description
Linear mixed effects models can be used to estimate long-term trends and examine the effects of baseline and concomitant factors on these trends.
Time Frame
Up to 10 years
Title
HRQL assessed using Sexual Health Inventory for Men
Description
Linear mixed effects models can be used to estimate long-term trends and examine the effects of baseline and concomitant factors on these trends.
Time Frame
Up to 10 years
Title
Incidence rates of the study end-points
Description
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.
Time Frame
Up to 10 years

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saro Armenian, DO
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs