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Prostate CancerPhase 3NCT00023829

Adjuvant Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer

A Phase 3 study testing bicalutamide, flutamide and releasing hormone agonist therapy in people with Prostate Cancer, run by Radiation Therapy Oncology Group at 1 site in Canada.

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. Androgens can stimulate the growth of prostate cancer cells. Drugs such as, flutamide or bicalutamide may stop the adrenal glands from producing androgens. Read more about this study

Who is it for?
Ages 0 to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
bicalutamide, flutamide and releasing hormone agonist therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteCanada
Study dates
Aug 2001to Jun 2004
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 0 to 120 years
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer
  • T2-3, N0, M0
  • No metastatic disease
  • High-risk for PSA relapse as defined by Gleason score 7 or higher and ≥ 1 of the following OR Gleason score < 7 and ≥ 2 of the following:
  • Preoperative PSA > 10 ng/mL
  • Positive surgical margins
  • Seminal vesicle invasion
  • Preoperative PSA ≤ 40.0 ng/mL
  • Postoperative PSA ≤ 0.2 ng/mL
  • Negative lymph node status by lymph node sampling or dissection
  • If lymph node status is unknown, must have < 5% risk of involvement by Roach formula

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 130,000/mm^3
  • Hemoglobin ≥ 11.4 g/dL

Hepatic:

  • ALT ≤ 3 times normal

Renal:

  • Creatinine ≤ 2.5 mg/dL

Other:

  • No other prior or concurrent invasive malignancy within the past 5 years except superficial nonmelanoma skin cancer
  • No other major medical or psychiatric illness that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 5 years since prior chemotherapy

Endocrine therapy:

  • At least 60 days since prior finasteride
  • At least 90 days since prior testosterone
  • Prior pharmacologic androgen ablation for prostate cancer allowed if initiated within the past 10 months (must switch to study ablation therapy OR discontinue therapy if randomized to receive radiotherapy only)

Radiotherapy:

  • No prior radiotherapy to the pelvis
  • No concurrent intensity-modulated radiotherapy

Surgery:

  • No prior orchiectomy

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: Phase III Randomized Study of Adjuvant Therapy for High Risk pT3N0 Prostate Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Drugs such as, flutamide or bicalutamide may stop the adrenal glands from producing androgens. Giving radiation therapy with hormone therapy after surgery to remove the tumor may kill any tumor cells remaining after surgery and be an effective treatment for stage II or stage III prostate cancer. It is not yet known if radiation therapy combined with hormone therapy is more effective than either radiation therapy alone or hormone therapy alone in treating stage II or stage III prostate cancer. (Hormone therapy alone group closed as of 12/9/2002.)

PURPOSE: Randomized phase III trial to compare the effectiveness of adjuvant radiation therapy plus hormone therapy to that of radiation therapy alone or hormone therapy alone in treating patients who have stage II or stage III prostate cancer.

Read the detailed description

OBJECTIVES:

  • Compare the overall survival, disease-free survival, freedom from distant metastases, and freedom from PSA failure in patients with high-risk stage II or III prostate cancer treated in the adjuvant setting with radiotherapy and hormonal therapy vs radiotherapy alone.
  • Compare the qualitative and quantitative toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to seminal vesicle invasion (yes vs no), preoperative PSA (10 ng/mL or less vs greater than 10 ng/mL), Gleason score (2-6 vs 7 vs 8-10), positive surgical margins (yes vs no), and neoadjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 3 treatment arms. (Arm III closed to accrual as of 12/9/2002.)

  • Arm I: Patients undergo radiotherapy once daily 5 days a week for 7 weeks. Beginning the first day of radiotherapy, patients also receive hormonal therapy comprising a luteinizing-hormone-releasing hormone agonist once every 1-4 months for 2 years AND oral flutamide 3 times daily OR oral bicalutamide once daily for 1 month.
  • Arm II: Patients undergo radiotherapy as in arm I.
  • Arm III (Closed to accrual as of 12/9/2002):Patients receive hormonal therapy as in arm I.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,398 patients (699 per treatment arm) will be accrued for this study within 5 years. (Arm III closed to accrual as of 12/9/2002.)

Conditions
Prostate Cancer
Being tested
bicalutamide, flutamide, releasing hormone agonist therapy, adjuvant therapy, radiation therapy
Keywords
stage III prostate cancer, stage IIB prostate cancer, stage IIA 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

  • flutamideDrug

  • releasing hormone agonist therapyDrug

  • adjuvant therapyProcedure or surgery

  • radiation therapyRadiation

Study groups in NCT00023829
Study groupRoleWhat they receive
LH-RH agonist plus radiation therapyExperimentalLuteinizing hormone-releasing hormone (LH-RH) agonist x 2 years plus radiation therapy (RT) to 63.0 - 66.6 Gy
Receives: Drug: bicalutamide; Drug: flutamide; Drug: releasing hormone agonist therapy; Procedure: adjuvant therapy; Radiation: radiation therapy
Radiation therapy aloneActive comparatorRadiation therapy alone to 63.0 - 66.6 Gy
Receives: Procedure: adjuvant therapy; Radiation: radiation therapy
LH-RH agonist aloneActive comparatorLuteinizing hormone-releasing hormone (LH-RH) agonist x 2 years
Receives: Drug: bicalutamide; Drug: flutamide; Drug: releasing hormone agonist therapy; Procedure: adjuvant therapy

What is being measured

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

  1. Overall survival

    Measured: From the date of randomization to the date of death due to any cause

Secondary outcomes (3)

  1. Disease-Free Survival

    Measured: From the date of randomization to the date of first documented local progression or distant failure

  2. Distant Failure

    Measured: From the date of randomization to the date of frist documented metastatic disease

  3. Biochemical Failure (detectable PSA)

    Measured: From the date of randomization to the date of developing a PSA of 0.5 ng/ml or greater over the entry PSA

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 startAug 2001
  3. Primary completionJun 2004
  4. Study completionJun 2004

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
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00023829
Sponsor's protocol ID
RTOG-P-0011
Other IDs
CDR0000068868, CAN-NCIC-PR9
Status last verified
Nov 2013
First submitted
13 Sep 2001
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bicalutamide, flutamide and releasing hormone agonist therapy in people with Prostate Cancer, run by Radiation Therapy Oncology Group at 1 site in Canada.

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 Oct 2020. 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 Canada. 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?

Overall survival (time frame: From the date of randomization to the date of death due to any cause). 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 NCT00023829.

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 Oct 2020.

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