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


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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


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.

This is an investigational study.

Up to 500 patients will take part in this study. All will be enrolled at MD Anderson.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

Registry (research database)

Outcome Time Frame:

Analyze data annually beginning once 100 patients have 1 year of follow-up; Anticipate annual enrollment of 100 patients.

Safety Issue:

No

Principal Investigator

Deborah A Kuban, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2008-0254

NCT ID:

NCT00850941

Start Date:

January 2009

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Registry
  • Research Database
  • Prostate cancer
  • Casodex
  • Flutamide
  • Goserelin Acetate
  • Leuprolide Acetate
  • Radiation
  • PSA
  • Post-prostatectomy
  • Radiation Therapy
  • Prostate Specific Antigen
  • Adenocarcinoma
  • Radical Prostatectomy
  • Bicalutamide
  • Zoladex
  • Lupron Depot
  • Tissue banking
  • Hormones
  • Prostatic Neoplasms

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030