Radiation Therapy for Rising Prostate Specific Antigen (PSA) Post-prostatectomy

May 13, 2019 updated by: M.D. Anderson Cancer Center

The goal of this clinical research study is to create a registry (research database) of clinical data about patients who receive radiation therapy, with or without hormone therapy, to treat prostate cancer that has come back after surgical removal of the prostate. This treatment is standard and the actual treatment is not part of this protocol.

The goal of this clinical research study is to create a registry (research database) of clinical data about patients who receive radiation therapy, with or without hormone therapy, to treat prostate cancer that has come back after surgical removal of the prostate. This treatment is standard and the actual treatment is not part of this protocol.

Researchers want to collect data and use this registry to learn about the long-term status of prostate cancer after these treatments.

This is an investigational study.

Up to 500 patients will take part in this study. All will be enrolled at MD Anderson, Spartanburg Regional Healthcare System, and/or MD Anderson Cancer Center Albuquerque.

Researchers want to collect data and use this registry to learn about the long-term status of prostate cancer after these treatments.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Standard Treatment:

If you are found to be eligible and you choose to take part, you will be enrolled in this study. Study participants will be those who are receiving the standard radiation treatment for prostate cancer, which has come back after surgical removal of the prostate. If your PSA level is lower, you will receive radiation alone. If your PSA level is higher, you will receive hormone therapy in addition to radiation. You will sign a separate consent form that will describe these treatments and their risks in more detail. This study requires no other treatment. The main purpose of this study is data gathering through the use of questionnaires and tissue banking.

Follow-Up Tests

After your treatment (radiation with or without hormone therapy), you will receive routine follow-up care. The results of the following routine tests will be entered into the registry:

  • After completing radiation, blood (about 1 tablespoon) will be drawn to check your PSA levels every 3 months for the first 2 years, every 6 months for the next 3 years, and every year from then on.
  • If you receive hormone therapy, additional blood (about 1 tablespoon) will be drawn to check the levels of testosterone hormone. These blood tests to check your testosterone levels will be drawn at the same time as your PSA blood tests, until your testosterone levels are in the normal range.
  • Every 6 months for the first 2 years after completing radiation, you will have a physical exam and a digital rectal exam. After that, the physical exam and digital rectal exam will be repeated every year from then on.

Information Collection:

While you are on study, on a long-term basis, researchers will collect information from your medical records about the status of the disease. This information will be entered into the registry. To identify you, the registry uses your medical record number instead of your name or other identifying information. The registry is password-protected to keep the data secure.

Length of Study Participation:

You will be on study for as long as you agree to keep taking part. If you go off study, your data will no longer be entered into the registry.

Study Type

Observational

Enrollment (Actual)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87110
        • Kaseman Presbyterian Hospital
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional Healthcare System
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Patients having a rising prostate-specific antigen (PSA) level after prostate was surgically removed, meaning prostate cancer return.

Description

Inclusion Criteria:

  1. Adenocarcinoma of the prostate definitively treated by radical prostatectomy.
  2. Patients must have no evidence of nodal or distant metastasis by clinical and radiologic staging to include bone scan and CT scan or MRI of the abdomen and pelvis. Patients with clinical or radiographic local recurrence are eligible. In patients with Gleason score less than or equal to 7 and PSA less than or equal to 1, CT or MRI of the abdomen is recommended but not required.
  3. Rising PSA after prostatectomy defined as at least 2 consecutive rises. If total PSA < 0.2 ng/ml, surgical pathology must also show extracapsular extension, positive margins, or seminal vesicle involvement.
  4. Total PSA < 5 ng/ml within 12 weeks prior to starting radiation or hormone therapy.
  5. Patients with PSA greater than or equal to 0.5 ng/ml may have up to 3 months of an LHRH agonist and an anti-androgen immediately prior to enrollment.
  6. All patient must have a serum testosterone of 150 ng/dl or greater documented prior to initiation of hormone therapy. Alternatively, patients without documentation of serum testosterone prior to initiation of hormone therapy should not have had any other prior hormone therapy within the 24 months preceding initiation of hormone therapy.

Exclusion Criteria:

  1. Patients with pathologically positive pelvic lymph nodes at prostatectomy.
  2. Patients with positive prostascint scans outside prostatic fossa.
  3. Any chemotherapy, immunotherapy, biological therapy for cancer within 90 days of enrollment.
  4. Hormone therapy (specifically LHRH agonist or antagonist, non-steroidal or steroidal antiandrogens) of more than 6 months duration at any time in the past for prostate cancer.
  5. Contraindications to external beam radiation therapy to include previous pelvic radiation, inflammatory bowel disease or history of collagen vascular disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Questionnaire
Prognostic factors and outcome for patients treated with radiation with curative intent for rising Prostate Specific Antigen (PSA) post-prostatectomy.
Behavioral: Questionnaire
Information collection.
Other Names:
  • Survey
  • Registry
  • Quality of Life Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Registry (research database)
Time Frame: Analyze data annually beginning once 100 patients have 1 year of follow-up; Anticipate annual enrollment of 100 patients.
Analyze data annually beginning once 100 patients have 1 year of follow-up; Anticipate annual enrollment of 100 patients.

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life Assessment
Time Frame: At the 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year follow-up visits.
At the 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year follow-up visits.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Deborah A Kuban, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2009

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

February 23, 2009

First Submitted That Met QC Criteria

February 23, 2009

First Posted (Estimate)

February 25, 2009

Study Record Updates

Last Update Posted (Actual)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 13, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-0254

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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