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

NCT00482807 | Completed Phase 1 DMC

• 2 other identifiers: 0195-04-FBP30CA036727
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Prostate Cancer

Keywords

stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer; adenocarcinoma of the prostate; recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• Toxicity rate

  Toxicity rate as assessed by NCI CTCAE v3.0

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

Secondary Outcomes (2)

• Progression-free survival

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

• Maximum tolerated dose (MTD) of docetaxel

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

Study Arms (1)

Docetaxel, intensity-modulated radiation therapy and hormone therapy

EXPERIMENTAL

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.

Drug: bicalutamide; Drug: docetaxel; Drug: goserelin; Radiation: intensity-modulated radiation therapy

Interventions

bicalutamide DRUG

Also known as: Casodex

Docetaxel, intensity-modulated radiation therapy and hormone therapy

docetaxel DRUG

Also known as: Docefrez, Taxotere

Docetaxel, intensity-modulated radiation therapy and hormone therapy

goserelin DRUG

Also known as: Zoladex

Docetaxel, intensity-modulated radiation therapy and hormone therapy

intensity-modulated radiation therapy RADIATION

Docetaxel, intensity-modulated radiation therapy and hormone therapy

Eligibility Criteria

• Age: 19 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \. 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Nebraska: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide; Docetaxel; Goserelin; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Ralph Hauke, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

• Elizabeth C Reed, MD

  University of Nebraska

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2007
• First Posted: June 5, 2007
• Study Start: August 31, 2004
• Primary Completion: March 9, 2010
• Study Completion: March 9, 2010
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

US (1)