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Prostate CancerPhase 2NCT00006359

Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer

A Phase 2 study testing LHRH agonist, antiandrogen and radiation therapy in people with Prostate Cancer, run by Alliance for Clinical Trials in Oncology at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Read more about this study

Who is it for?
Ages 18 to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
LHRH agonist, antiandrogen and radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
26 sitesUnited States
Study dates
Sep 2000to Mar 2012
Phase
Phase 2
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 18 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • Must have one of the following prognostic factors:
  • Stage T1-2, N0; prostate-specific antigen (PSA) ≤ 10 ng/mL; and Gleason score > 6
  • Stage T1-2, N0; PSA > 10 ng/mL and < 20 ng/mL; and Gleason score ≤ 6
  • Stage T3a, N0; PSA ≤ 10 ng/mL; and Gleason score ≤ 6
  • Prostate volume < 60 cc by transrectal ultrasound
  • No distant or nodal metastases
  • No metastatic disease by bone scan, CT scan, or MRI

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic:

  • Bilirubin ≤ 1.5 times upper limit of normal

Renal:

  • Not specified

Other:

  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy for prostate cancer

Chemotherapy:

  • No prior chemotherapy for prostate cancer

Endocrine therapy:

  • Prior androgen-suppression therapy for up to 4 weeks duration allowed if initiated within 4 weeks of study radiotherapy
  • No other prior hormonal therapy

Radiotherapy:

  • No prior radiotherapy for prostate cancer

Surgery:

  • No prior surgery for prostate cancer
  • No prior transurethral resection of the prostate

Other:

  • No prior alternative therapy (e.g., PC-SPES) for prostate cancer

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

United States26 sites

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees

    Camden, New Jersey, 08103

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio, 43210

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Union Hospital Cancer Center at Union Hospital

    Elkton MD, Maryland, 21921

  • Hudner Oncology Center at Saint Anne's Hospital

    Fall River, Massachusetts, 02721

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19718

  • Florida Hospital Cancer Institute at Florida Hospital Orlando

    Orlando, Florida, 32803

  • Washoe Cancer Services at Washoe Medical Center - Reno

    Reno, Nevada, 89502

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • Arch Medical Services, Incoroporated at Center for Cancer Care Research

    St Louis, Missouri, 63141

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    Syracuse, New York, 13057

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Veterans Affairs Medical Center - Syracuse

    Syracuse, New York, 13210

  • Community General Hospital of Greater Syracuse

    Syracuse, New York, 13215

  • St. Francis Hospital

    Wilmington, Delaware, 19805

  • Zimmer Cancer Center at New Hanover Regional Medical Center

    Wilmington, North Carolina, 28401

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157

  • UMASS Memorial Cancer Center - University Campus

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: Phase II Trial of Androgen Suppression for 6 Months Combined With External Beam Radiotherapy (EBRT) With Brachytherapy (BT) Boost for Intermediate Risk Prostate Cancer

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving these drugs together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well androgen suppression with either leuprolide or goserelin and either flutamide or bicalutamide together with radiation therapy works in treating patients with prostate cancer.

Read the detailed description

OBJECTIVES:

  • Determine the feasibility of androgen-suppression therapy combined with external-beam radiotherapy and boost brachytherapy (EBRT+BT) in patients with intermediate-risk localized prostate cancer.
  • Determine the safety of EBRT+BT in these patients.
  • Determine, in a preliminary manner, the efficacy of EBRT+BT in terms of rate of local recurrence at 5 years, time to prostate-specific antigen failure, and time to first rectal/bladder injury, in these patients.

OUTLINE: Patients receive either leuprolide intramuscularly or goserelin subcutaneously once every 12 weeks for a total of 24 weeks. Patients also receive either oral flutamide three times daily or oral bicalutamide once daily for 4 weeks.

Within 4 weeks after initiation of androgen-suppression therapy, patients undergo external-beam radiotherapy (EBRT) once daily, 5 days a week, for 5 weeks. At 2-4 weeks after completion of EBRT, patients undergo transrectal ultrasound-guided boost brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds.

Patients are followed every 3 months for 2 years and then every 6 months for 4 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Conditions
Prostate Cancer
Being tested
LHRH agonist, antiandrogen, radiation therapy, Brachytherapy boost
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LHRH agonistDrug

    Lupron: 22.5mg IM injection q 12 wks x 2 OR Zoladex: 10.8 mg subQ injection q 12 wks x 2

  • antiandrogenDrug

    flutamide 250 mg PO tid for 4 wks OR casodex 50 mg PO daily for 4 wks

  • radiation therapyRadiation

    4500 cGy total dose given days 1-5 for 5 weeks following initiation of androgen suppression (25 fractions)

  • Brachytherapy boostRadiation

    Iodine 125 0.3 to 0.5 U per seed OR palladium 103 1.04 to 1.4 U per seed as implant; prescribed dose of I-125 100 Gy (TG-43) and Pd-103 90 Gy

Study groups in NCT00006359
Study groupRoleWhat they receive
Androgen suppression + EBRT + BrachytherapyExperimentalAndrogen suppression with external beam radiation therapy followed by brachytherapy boost
Receives: Drug: LHRH agonist; Drug: antiandrogen; Radiation: radiation therapy; Radiation: Brachytherapy boost

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Toxicity

    Measured: q 3 mon for 2 yrs post tx initiation

Secondary outcomes (2)

  1. Time to PSA failure

    Measured: 6 years

  2. Survival

    Progression free and overall survival will be assessed

    Measured: 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startSep 2000
  3. Primary completionOct 2007
  4. Study completionMar 2012

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006359
Sponsor's protocol ID
CALGB-99809
Other IDs
U10CA031946, CALGB-99809, CDR0000068228
Status last verified
Jul 2016
First submitted
4 Oct 2000
Last updated
18 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Hurwitz MD, Halabi S, Archer L, et al.: Combination external beam radiation and brachytherapy boost with androgen suppression for treatment of intermediate-risk prostate cancer: long-term results of CALGB 99809. [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-192, 2010.

  • Hurwitz MD, Halabi S, Ou SS, McGinnis LS, Keuttel MR, Dibiase SJ, Small EJ. Combination external beam radiation and brachytherapy boost with androgen suppression for treatment of intermediate-risk prostate cancer: an initial report of CALGB 99809. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):814-9. doi: 10.1016/j.ijrobp.2008.01.010. Epub 2008 Apr 11.

    PubMed 18407435

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LHRH agonist, antiandrogen and radiation therapy in people with Prostate Cancer, run by Alliance for Clinical Trials in Oncology at 26 sites 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?

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 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Toxicity (time frame: q 3 mon for 2 yrs post tx initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006359, which also lists 2 linked publications.

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 18 Jul 2016.

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