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

NCT ID: NCT03035500

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-23

Study Completion Date

2026-07-28

Brief Summary

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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

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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.

Conditions

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Cancer Survivor Prostate Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Receive health education

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Long-term Follow-up

Intervention Type OTHER

Undergo long-term follow-up using survivorship care plan

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Educational Intervention

Receive health education

Intervention Type OTHER

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Long-term Follow-up

Undergo long-term follow-up using survivorship care plan

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Quality of Life Assessment

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saro Armenian, DO

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2017-00090

Identifier Type: REGISTRY

Identifier Source: secondary_id

07101

Identifier Type: OTHER

Identifier Source: secondary_id

07101

Identifier Type: -

Identifier Source: org_study_id

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