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Active, Not Recruiting

NCT Number: NCT03035500

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Survivor Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Carcinoma Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Receive health education

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

laboratory biomarker analysis

Other

Correlative studies

Long-term Follow-Up

Other

Undergo long-term follow-up using survivorship care plan

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Long-term Follow-up After Prostate Cancer

Important dates

Study start
2008
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2017
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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