Clinical trial NCT03035500: Long-Term Follow-Up in Patients With Prostate Cancer After Surgery
Official title: Long-term Follow-up After Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer Survivor
Prostate Carcinoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-01-30
Enrollment: 2500
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: HRQL assessed using Expanded Prostate Cancer Index Composite
timeFrame: Up to 10 years
measure: HRQL assessed using Sexual Health Inventory for Men
timeFrame: Up to 10 years
measure: Incidence rates of the study end-points
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Saro Armenian, DO
role: PRINCIPAL_INVESTIGATOR
References: