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

NCT03035500 | Active Not Recruiting DMC

• 2 other identifiers: 07101NCI-2017-00090
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Survivor; Prostate Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 10 years

• 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.

  Up to 10 years

• 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.

  Up to 10 years

Study Arms (1)

Supportive Care (long-term follow-up)

EXPERIMENTAL

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.

Other: Educational Intervention; Other: Laboratory Biomarker Analysis; Other: Long-term Follow-up; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Educational Intervention OTHER

Receive health education

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Supportive Care (long-term follow-up)

Laboratory Biomarker Analysis OTHER

Correlative studies

Supportive Care (long-term follow-up)

Long-term Follow-up OTHER

Undergo long-term follow-up using survivorship care plan

Supportive Care (long-term follow-up)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive Care (long-term follow-up)

Questionnaire Administration OTHER

Ancillary studies

Supportive Care (long-term follow-up)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current treatment with testosterone replacement or androgen deprivation therapy
• Treatment for another noncutaneous cancer within the past 2 years

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Saro Armenian, DO

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 30, 2017
• Study Start: July 23, 2008
• Primary Completion (Estimated): July 28, 2026
• Study Completion (Estimated): July 28, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (1)