Cancer SurvivorNCT03035500
Long-Term Follow-Up in Patients With Prostate Cancer After Surgery
A study testing Educational Intervention, Laboratory Biomarker Analysis and Long-term Follow-up in people with Cancer Survivor and Prostate Carcinoma, run by City of Hope Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Cancer Survivor, Prostate Carcinoma
- What is being tested?
- Educational Intervention, Laboratory Biomarker Analysis and Long-term Follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2008to 10 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current treatment with testosterone replacement or androgen deprivation therapy
- Treatment for another noncutaneous cancer within the past 2 years
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Long-term Follow-up After Prostate Cancer
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Cancer Survivor, Prostate Carcinoma
- Being tested
- Educational Intervention, Laboratory Biomarker Analysis, Long-term Follow-up, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive health education
Laboratory Biomarker AnalysisOther
Correlative studies
Long-term Follow-upOther
Undergo long-term follow-up using survivorship care plan
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Educational Intervention; Other: Laboratory Biomarker Analysis; Other: Long-term Follow-up; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start23 Jul 2008
- Primary completion10 Aug 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Saro Armenian, DO, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035500
- Sponsor's protocol ID
- 07101
- Other IDs
- NCI-2017-00090, 07101
- Status last verified
- Oct 2026
- First submitted
- 25 Jan 2017
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up After Prostate Cancer
- ClinicalTrials.gov ID
- NCT03035500
- Acronym / sponsor ID
- 07101
- Conditions
- Cancer Survivor, Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Jul 2008 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (long-term follow-up) | Experimental | Other: Educational Intervention, Other: Laboratory Biomarker Analysis, Other: Long-term Follow-up, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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 may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Current treatment with testosterone replacement or androgen deprivation therapy
- Treatment for another noncutaneous cancer within the past 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive health education | Other | Supportive Care (long-term follow-up) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Supportive Care (long-term follow-up) |
| Long-term Follow-upUndergo long-term follow-up using survivorship care plan | Other | Supportive Care (long-term follow-up) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive Care (long-term follow-up) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (long-term follow-up) |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saro Armenian, DO principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Laboratory Biomarker Analysis and Long-term Follow-up in people with Cancer Survivor and Prostate Carcinoma, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRQL assessed using Expanded Prostate Cancer Index Composite (time frame: Up to 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.