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Prostate CancerPhase 3NCT00067015

Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer

A Phase 3 study testing bicalutamide, goserelin acetate and assessment of therapy complications in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site 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: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue and may improve quality of life and help patients live more comfortably. Androgens can stimulate the growth of prostate cancer 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?
bicalutamide, goserelin acetate and assessment of therapy complications
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
May 2003to Sep 2008
Phase
Phase 3
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
  • Unfavorable-risk disease, including at least 2 of the following characteristics:
  • Prostate-specific antigen level greater than 10 ng/mL
  • Gleason score greater than 7
  • Stage T4
  • Intermediate-risk disease with a Gleason score of at least 8 allowed
  • Lymph nodes clinically negative by imaging studies or histologically negative by node sampling or lymph node dissection
  • Prostate size less than 75 grams
  • No distant metastases by bone scan, CT scan, or MRI

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 80-100%

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT no greater than 1.5 times ULN

Renal

  • Not specified

Other

  • No documented history of inflammatory bowel disease
  • No bilateral hip replacements
  • No other invasive cancer except localized basal cell or squamous cell skin cancer unless disease free for at least 5 years
  • No major medical or psychiatric illness that would preclude study completion, compliance, or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for prostate cancer

Endocrine therapy

  • No prior androgen-deprivation therapy

Radiotherapy

  • No prior pelvic radiotherapy
  • No prior prostate brachytherapy

Surgery

  • No prior bilateral orchiectomy
  • No prior radical prostatectomy
  • No prior cryotherapy for prostate cancer

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

About this study

Official title: Phase III Randomized Trial Study Comparing the Outcome of High-Dose IMRT (86.4 GY) Alone With IMRT to 75.6 GY Plus Neoadjuvant/Adjuvant Androgen Deprivation in Patients With High Grade Intermediate Risk and Unfavorable Risk Prostate Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue and may improve quality of life and help patients live more comfortably. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin and bicalutamide may fight cancer by stopping the production of androgens. It is not yet known whether radiation therapy is more effective with or without goserelin and bicalutamide in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation therapy with or without bicalutamide and goserelin in treating patients who have prostate cancer.

Read the detailed description

OBJECTIVES:

  • Compare the quality of life of patients with high-grade intermediate-risk or unfavorable-risk adenocarcinoma of the prostate when treated with high-dose intensity-modulated radiotherapy alone versus with androgen deprivation comprising bicalutamide and goserelin.
  • Compare the prostate-specific antigen relapse-free, distant metastases-free, and overall survival of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare the local control in patients treated with these regimens, based on post-treatment sextant biopsies performed 4 years after study completion.

OUTLINE: This is a randomized study. Patients are stratified according to prostate-specific antigen level, Gleason score, and clinical stage. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo high-dose intensity-modulated radiotherapy (IMRT) 4-5 times per week for 10 weeks (a total of 48 treatments).
  • Arm II: Patients receive oral bicalutamide once daily for 18.5 weeks. Three to seven days after the initiation of bicalutamide, patients also receive goserelin subcutaneously monthly for 2 years. Beginning after 10 weeks of hormonal therapy, patients undergo concurrent high-dose IMRT 4-5 times per week for 8.5 weeks (a total of 42 treatments). Patients discontinue bicalutamide on or near the end of radiotherapy.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 3 months for 1.5 years after the completion of radiotherapy, then 6 months later, and then annually for 2 years.

Patients are followed every 6-8 months for 4 years and then annually for 2 years.

PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 4-5 years.

Conditions
Prostate Cancer
Being tested
bicalutamide, goserelin acetate, assessment of therapy complications, quality-of-life assessment, radiation therapy
Keywords
adenocarcinoma of the prostate, 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.

  • bicalutamideDrug

  • goserelin acetateDrug

  • assessment of therapy complicationsProcedure or surgery

  • quality-of-life assessmentProcedure or surgery

  • radiation therapyRadiation

Study groups in NCT00067015
Study groupRoleWhat they receive
IMRT alone to 86.4 GyExperimentalExternal radiotherapy is given for 10 weeks, Monday through Friday for a total of 48 sessions. The total dose of radiotherapy delivered during these 10 weeks is 86.4 Gy. The radiation treatments are delivered with a high precision technique called intensity modulated radiotherapy or IMRT. For this treatment, no hormonal therapy is required.
Receives: Procedure: assessment of therapy complications; Procedure: quality-of-life assessment; Radiation: radiation therapy
IMRT TO 75.6 Gy plus Adjuvant Androgen DeprivationExperimentalPrior to a planned course of radiotherapy, which will last for eight and a half weeks, 10 weeks of hormonal therapy are given. The hormonal therapy will start with a daily pill called Casodex. Three to seven days after starting this pill, a Zoladex injection will be administered in addition to the Casodex pill. Zoladex hormonal therapy is given in the form of a monthly injection. After 10 weeks from the initiation of hormone therapy, you will begin external radiotherapy. For these treatments only 42 treatment sessions are given. The total dose of radiotherapy delivered during these 8.5 weeks is 75.6 Gy. The hormone injections continue during the radiation treatments and for 2 years after the radiation treatments. The pills are only taken for the 10 weeks before and also during the radiation treatments, however afterwards the pills are discontinued.
Receives: Drug: bicalutamide; Drug: goserelin acetate; Procedure: assessment of therapy complications; Procedure: quality-of-life assessment; Radiation: radiation therapy

What is being measured

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

  1. compare the quality of life

    Measured: 2 years

Secondary outcomes (2)

  1. response

    Measured: 2 years

  2. toxicity

    Measured: 2 years

Timeline

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

  1. First posted11 Aug 2003 (estimated)
  2. Study startMay 2003
  3. Primary completionOct 2004
  4. Study completionSep 2008

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00067015
Sponsor's protocol ID
03-040
Other IDs
P30CA008748, MSKCC-03040
Status last verified
Dec 2015
First submitted
8 Aug 2003
Last updated
22 Dec 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bicalutamide, goserelin acetate and assessment of therapy complications in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site 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 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

compare the quality of life (time frame: 2 years). 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 NCT00067015.

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 22 Dec 2015.

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