Long-Term Follow-Up for Prostate Cancer

Age: Any Age

Sex: Male

Trial Phase: Academic

Sponsor: City of Hope Medical Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2500 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on testosterone replacement or androgen deprivation therapy.

What data supports the effectiveness of the treatment Educational Intervention, PRE-ACT Model, Patient Navigator Model, Laboratory Biomarker Analysis, Imbruvica, Long-term Follow-up, Quality-of-Life Assessment, Prolia, Xgeva, Questionnaire Administration, Survey Administration, Assessment Tool for prostate cancer?

The research highlights the importance of long-term follow-up in prostate cancer treatment, showing that survival rates and recurrence can be effectively monitored over time. Additionally, the use of conformal radiation therapy combined with androgen deprivation has shown improved outcomes in locally advanced prostate cancer, suggesting that similar comprehensive approaches may benefit patients in this trial. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

The research indicates that long-term follow-up is important for monitoring safety after prostate cancer treatments like radiotherapy, as severe side effects can occur years later. This suggests that while treatments are generally safe, there is a risk of late-developing side effects that require careful monitoring. ^{1 6 7 8 9}

How does the Long-term Follow-up treatment for prostate cancer differ from other treatments?

The Long-term Follow-up treatment for prostate cancer is unique because it focuses on monitoring and managing long-term complications and recurrence of cancer, rather than providing immediate therapeutic intervention. This approach is particularly important for elderly patients who may have other health issues and emphasizes the importance of ongoing care and support to improve quality of life. ^{1 10 11 12 13}

Research Team

Saro Armenian, DO

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for prostate cancer survivors who had surgery at least a year ago, are currently free of cancer or have stable disease, and haven't had radiation or chemo for prostate cancer. Men with other urologic cancers or those on hormone therapies can't join.

Inclusion Criteria

My cancer has not come back or spread after treatment.

I have prostate cancer and no history of other urologic cancers.

I have been diagnosed with prostate cancer.

Exclusion Criteria

I am currently on testosterone replacement or androgen deprivation therapy.

Treatment for another noncutaneous cancer within the past 2 years

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Post-Surgery

Participants undergo definitive surgical therapy for prostate cancer

Immediate post-surgery

Long-term Follow-up

Participants receive a written survivorship care plan including comprehensive health evaluation and health education beginning 1 year post surgery

Up to 10 years

Treatment Details

Interventions

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

Trial Overview The study looks at the effectiveness of long-term follow-up care in men after prostate cancer surgery. It includes educational materials, regular questionnaires, lab tests to check health markers, and assessments of life quality over time.

Participant Groups

Group I: Supportive Care (long-term follow-up) Experimental Treatment 5 Interventions

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 Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

References

1. Egypt pubmed.ncbi.nlm.nih.gov

Long-Term Follow-Up after Prostatectomy for Prostate Cancer and the Need for Active Monitoring. [2022]

2. France pubmed.ncbi.nlm.nih.gov

[Follow-up of prostate cancer. Guidelines of the Comité de Cancérologie de l'Association Française d'Urologie]. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Early prostate cancer: the national results of radiation treatment from the Patterns of Care and Radiation Therapy Oncology Group studies with prospects for improvement with conformal radiation and adjuvant androgen deprivation. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Definitive therapy for prostate carcinoma: Mayo Clinic results at 15 years after treatment. [2004]

5. United States pubmed.ncbi.nlm.nih.gov

An evidence-based approach to prostate cancer follow-up. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Dose response in prostate cancer with 8-12 years' follow-up. [2019]

7. France pubmed.ncbi.nlm.nih.gov

[Surveillance after prostate cancer radiotherapy]. [2011]

8. England pubmed.ncbi.nlm.nih.gov

Risk of severe late toxicity after radiotherapy following radical prostatectomy - a nationwide study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Population-based study of long-term functional outcomes after prostate cancer treatment. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Follow-up after therapy for prostate cancer. Treating the problems and caring for the man. [2016]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Achieving optimal delivery of follow-up care for prostate cancer survivors: improving patient outcomes. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Time without PSA recurrence after radical prostatectomy as a predictor of future biochemical recurrence, metastatic disease and prostate cancer death: a prospective Scandinavian cohort study. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Adenocarcinoma of the prostate in Iceland: a population-based study of stage, Gleason grade, treatment and long-term survival in males diagnosed between 1983 and 1987. [2006]