- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03035500
Long-Term Follow-Up in Patients With Prostate Cancer After Surgery
Long-term Follow-up After Prostate Cancer
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- City of Hope Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supportive Care (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.
|
Correlative studies
Ancillary studies
Other Names:
Ancillary studies
Receive health education
Other Names:
Undergo long-term follow-up using survivorship care plan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HRQL assessed using Expanded Prostate Cancer Index Composite
Time Frame: 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.
|
Up to 10 years
|
|
HRQL assessed using Sexual Health Inventory for Men
Time Frame: 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.
|
Up to 10 years
|
|
Incidence rates of the study end-points
Time Frame: 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.
|
Up to 10 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Saro Armenian, DO, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Prostatic Neoplasms
- Investigative Techniques
- Health Services
- Health Care Facilities Workforce and Services
- Child Health Services
- Community Health Services
- Preventive Health Services
- Socioeconomic Factors
- Population Characteristics
- Methods
- Early Intervention, Educational
- Educational Status
Other Study ID Numbers
- 07101 (Other Identifier: City of Hope Medical Center)
- NCI-2017-00090 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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