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Prostate CancerPhase 1NCT00482807

Radiation Therapy, Docetaxel, and Hormone Therapy in High-Risk Locally Advanced Metastasized Prostate Cancer

A Phase 1 study testing bicalutamide, docetaxel and goserelin in people with Prostate Cancer, run by University of Nebraska 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: Specialized radiation therapy that delivers a high- dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping… Read more about this study

Who is it for?
Ages 19 to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
bicalutamide, docetaxel and goserelin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
31 Aug 2004to 9 Mar 2010
Phase
Phase 1
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 19 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed adenocarcinoma of the prostate
  • o Locally advanced disease (T1 -T3b, N1 or N2, M0) at high risk for recurrence
  • Biopsy-proven pelvic lymph node involvement
  • No T4 lesion
  • Prior androgen suppression within the past 14 months is allowed provided the following criterion is met:
  • o No biochemical evidence of PSA progression after androgen withdrawal
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  • 1. PSA progression, defined as 2 consecutive rising PSA values > 4.0 ng/mL taken ≥ 2 weeks apart
  • Karnofsky performance status 80-100%
  • absolute neutrophil count (ANC) ≥ 1,500/mm³
  • Hemoglobin ≥ 10 g/dL
  • Platelet count > 100,000/mm³
  • Bilirubin normal
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
  • Meets 1 of the following criteria:
  • Alkaline phosphatase (AP) normal and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 5 times upper limit of normal (ULN)
  • AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
  • AP ≤ 5 times ULN AND AST or ALT normal

Who cannot join

  • No evidence of distant metastasis, including any of the following:
  • Bone metastasis
  • Pathologic or radiographic evidence of lymph node involvement above the L4 - L5 interspace
  • No peripheral neuropathy > grade 1
  • No significant comorbidity that would preclude radiotherapy
  • No other prior malignancy except nonmelanoma skin cancer or any other cancer for which the patient has been disease-free for the past 5 years
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  • No hypersensitivity to docetaxel or other drugs formulated with polysorbate 80
  • No history of Crohn's disease, ulcerative colitis, or irritable bowel syndrome
  • No unrepaired inguinal hernia
  • No prior pelvic or abdominal radiotherapy or prostate brachytherapy implant
  • No prior prostatectomy
  • No prior pelvic or abdominal surgery that resulted in excessive amounts of small intestine located within the pelvis
  • No other concurrent investigational agents

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

Other trials in United States

About this study

Official title: Phase I Study Evaluating Extended Field Intensity Modulated Radiation Therapy and Docetaxel in Patients With Prostate Cancer Associated With Pelvic Node Metastasis

RATIONALE: Specialized radiation therapy that delivers a high- dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and bicalutamide, may lessen the amount of androgens made by the body. Giving radiation therapy together with chemotherapy and hormone therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with intensity-modulated radiation therapy and hormone therapy in treating patients with high-risk locally advanced prostate cancer with pelvic lymph node metastasis.

Read the detailed description

OBJECTIVES:

Primary

  • Determine, preliminarily, the grade III or IV toxicity rate of concurrent extended-field intensity-modulated radiotherapy (IMRT), docetaxel, and androgen deprivation therapy in patients with high-risk, locally advanced prostate cancer with pelvic lymph node metastasis.

Secondary

  • Determine, preliminarily, the progression-free survival of patients treated with this regimen.
  • Determine the maximum tolerated dose of docetaxel when administered with concurrent IMRT in this patients.

OUTLINE: This is a dose-escalation study of docetaxel.

Patients receive combined androgen deprivation therapy (if not already on combined hormonal therapy) comprising goserelin acetate* subcutaneously once every 3 months for up to 2 years and oral bicalutamide once daily beginning on day 1 and continuing until the completion of radiotherapy. Beginning at approximately week 9 of androgen deprivation therapy, patients receive docetaxel IV over 1 hour once weekly for up to 9 weeks. Concurrently with chemotherapy, patients undergo intensity-modulated radiotherapy 5 days a week for up to 45 fractions (9 weeks).

Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Note: *Not required for patients who have undergone bilateral orchiectomy

After completion of study therapy, patients are followed periodically for 5 years.

Conditions
Prostate Cancer
Being tested
bicalutamide, docetaxel, goserelin, intensity-modulated radiation therapy
Keywords
stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate, recurrent 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

    Also called Casodex

  • docetaxelDrug

    Also called Docefrez, Taxotere

  • goserelinDrug

    Also called Zoladex

  • intensity-modulated radiation therapyRadiation

Study groups in NCT00482807
Study groupRoleWhat they receive
Docetaxel, intensity-modulated radiation therapy and hormone therapyExperimentalThis phase I trial is studying the side effects and best dose of docetaxel when given together with intensity-modulated radiation therapy and hormone therapy in treating patients with high-risk locally advanced prostate cancer with pelvic lymph node metastasis.
Receives: Drug: bicalutamide; Drug: docetaxel; Drug: goserelin; Radiation: intensity-modulated radiation therapy

What is being measured

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

  1. Toxicity rate

    Toxicity rate as assessed by NCI CTCAE v3.0

    Measured: during therapy and follow-up, & for 5 years after radiation is completed

Secondary outcomes (2)

  1. Progression-free survival

    Time to Prostate Specific Antigen (PSA) failure

    Measured: From start of therapy up to 5 years after radiation is complete

  2. Maximum tolerated dose (MTD) of docetaxel

    Maximum tolerated dose (MTD) of docetaxel (dose below which excess dose limiting toxicity, DLT, observed.) If 3 patients treated at that dose, then added 3 should be entered, that process proceeds down, so MTD becomes highest dose where no more than 1 toxicity observed in 6 patients.

    Measured: From start of therapy up to 5 years after radiation is complete

Timeline

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

  1. First posted5 Jun 2007 (estimated)
  2. Study start31 Aug 2004
  3. Primary completion9 Mar 2010
  4. Study completion9 Mar 2010

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00482807
Sponsor's protocol ID
0195-04-FB
Other IDs
P30CA036727
Status last verified
Nov 2023
First submitted
4 Jun 2007
Last updated
24 Nov 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing bicalutamide, docetaxel and goserelin in people with Prostate Cancer, run by University of Nebraska 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?

The sponsor lists 17 inclusion and 13 exclusion criteria. 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 24 Nov 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 rate (time frame: during therapy and follow-up, & for 5 years after radiation is completed). 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 NCT00482807.

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 24 Nov 2023.

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