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

City of Hope

Status: Active, not recruiting

Conditions: Prostate Carcinoma; Cancer Survivor

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03035500

07101 (Other Identifier)

NCI-2017-00090 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,500 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

2,500 participants in 1 patient group

Supportive Care (long-term follow-up)

Experimental group

Description:

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.

Treatment:

Other: Long-term Follow-up

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Other: Educational Intervention

Other: Laboratory Biomarker Analysis