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Randomized, Phase II Trial of Best Systemic Therapy or Best Systemic Therapy (BST) Plus Definitive Treatment (Radiation or Surgery) of the Primary Tumor in Metastatic (M1) Prostate Cancer (PC)


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

Randomized, Phase II Trial of Best Systemic Therapy or Best Systemic Therapy (BST) Plus Definitive Treatment (Radiation or Surgery) of the Primary Tumor in Metastatic (M1) Prostate Cancer (PC)


Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to 1 of 2 study groups based on when you join this study. You
will have an equal chance of being assigned to each group.

- If you are in Group 1, you will continue to receive standard of care systemic
treatment.

- If you are in Group 2, you will receive standard of care systemic treatment in addition
to surgery to remove your prostate or radiation therapy to the prostate. You and your
treating physician will decide if surgery or radiation therapy is the best choice for
you. Your treating physician will explain the surgery or radiation therapy and their
risks to you in more detail, and you will be asked to sign a separate consent form for
the procedure.

Study Visits:

Within 60 days after screening:

- You will have a physical exam, including a digital rectal exam (DRE).

- You will be asked how well you are able to perform the normal activities of daily
living (performance status).

- Blood (about 2-3 teaspoons) will be drawn for routine tests, to check your
prostate-specific antigen (PSA) levels, and testosterone levels.

- Urine will be collected for routine tests.

- You will complete a questionnaire about how you are feeling. It should take about 15
minutes to complete.

- You will have a bone scan, 2 CT scans of your abdomen and pelvis, and a chest X-ray or
a computed tomography (CT) scan of chest to check the status of the disease.

- You will have a endorectal Magnetic Resonance Imaging (MRI) scan of the prostate to
check the status of the disease.

- You will have a ultrasound-guided biopsy of the prostate to check the status of the
disease. To perform an ultrasound-guided biopsy, a needle is inserted into the affected
area using ultrasound imaging to collect cells or tissue from the tumor. The doctor
will use the imaging to guide the needle into the area. Two (2) types of samples may
be collected. It will either be a fine needle aspirate (FNA) that collects cells
and/or a core biopsy that collects a small piece of tissue.

Every 12 weeks while on study (starting at month 9):

- You will have a physical exam, including a DRE and any updates to your medical history
will be recorded.

- You will be asked about any side effects you may have had.

- You will be asked about any drugs or treatments you may be receiving, including
over-the-counter drugs, herbal remedies, vitamins, and/or supplements.

- Blood (about 2-3 teaspoons) will be drawn for routine tests, to check your liver
function, and to measure PSA and testosterone levels.

- You will complete a questionnaire about how you are feeling. It should take about 15
minutes to complete.

- If the study doctor thinks it is needed, you will have CT/MRI imaging scans to check
the status of the disease.

Length of Treatment:

You may continue your participation in this study for as long as the doctor thinks it is in
your best interest. You will be taken off the study treatment if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions.

Your active participation on the study will be over after the long-term follow-up phone
calls/emails (described below).

End-of-Treatment Visit:

Within 14 days after your study treatment is stopped, the following tests and procedures
will be performed:

- You will have a physical exam, including a DRE.

- You will be asked about any side effects you may have had.

- You will be asked about any drugs or treatments you may be receiving, including
over-the-counter drugs, herbal remedies, vitamins, and/or supplements.

- Blood (about 2-3 teaspoons) will be drawn for routine tests, to check your liver
function, and to measure PSA and testosterone levels.

- You will complete a questionnaire about how you are feeling. It should take about 15
minutes to complete.

- If the study doctor thinks it is needed, you will have CT/MRI imaging scans to check
the status of the disease.

- If you did not have surgery to remove your prostate and the disease has gotten worse,
you will have an ultrasound-guided biopsy of the prostate to check the status of the
disease and to help plan the next steps in your treatment. This biopsy will be standard
of care.

Long-Term Follow-Up:

Every 6 months after your end-of-treatment visit, you will be contacted by phone or e-mail
and you will be asked questions about how you are feeling. Each phone call should last
about 5 minutes. If you are not able to be contacted by phone or email, the study doctor
will review and record any updates to your medical record.

This is an investigational study. Using standard of care systemic treatment with surgery,
and/or radiation therapy are both groups FDA approved and commercially available.

Up to 120 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Male patients

2. 18 yrs and older

3. Histologically or cytologically proven prostate carcinoma

4. Documented evidence of M1 disease by AJCC (American Joint Committee on Cancer)
staging by Bone scan, CT and/or MRI.

5. Androgen dependent disease measured by declining PSA and do not display signs of
progression demonstrated by a rising PSA.

6. Treatment initiation with BST no longer than 6 months prior to randomization

7. ECOG PS 0 or 1

8. Life-expectancy based on comorbid conditions >2 years

9. Ability to understand and willingness to sign informed consent

10. Must be a candidate for surgery and/or radiation therapy

Exclusion Criteria:

1. Psychiatric or medical conditions which, in the opinion of the treating physician,
would not allow the patient to undergo the proposed treatments safely.

2. Known brain metastasis

3. Small cell carcinoma of the prostate

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival

Outcome Description:

Primary endpoint is progression-free survival, defined as the time interval from the start of initial best systemic therapy (BST) treatment to the date of disease progression or death, whichever occurred first.

Outcome Time Frame:

60 days

Safety Issue:

Yes

Principal Investigator

Brian F. Chapin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2012-0705

NCT ID:

NCT01751438

Start Date:

March 2013

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • Prostate carcinoma
  • Metastatic
  • M1
  • Best Systemic Therapy
  • BST
  • Androgen deprivation therapy
  • Bilateral orchiectomy
  • Radiation
  • Radiation Therapy
  • External beam radiation therapy
  • External-beam radiotherapy
  • Xray therapy
  • XRT
  • Surgery
  • Prostatic Neoplasms

Name

Location

University of Texas MD Anderson Cancer Center Houston, Texas  77030