Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

TERMINATED

Radiation Therapy and Docetaxel in Treating Patients Who Are Undergoing Surgery for Localized Prostate Cancer

Lead Sponsor:

OHSU Knight Cancer Institute

Conditions:

Prostate Cancer

Eligibility:

MALE

18-100 years

Phase:

PHASE1

PHASE2

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose (MTD) of neoadjuvant radiotherapy and docetaxel in patients who are undergoing prostatectomy for high-risk localized prostate cancer. * Det...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA; DISEASE CHARACTERISTICS:
  • Histologically confirmed adenocarcinoma of the prostate
  • Localized disease, meeting 1 of the following staging criteria:
  • Clinical stage T2b (palpable bilateral movement) disease
  • Surgically resectable T3 disease
  • Meets any of the following high-risk\* features:
  • PSA ≥ 15 ng/mL
  • Gleason grade ≥ 4+3 (4+3, 4+4, or 5+any, but not 3+4) NOTE: \*High risk defined as \> 50% chance of failure with local therapy
  • Plans to undergo prostatectomy as primary therapy
  • No evidence of lymph nodes ≥ 2 cm in diameter by pelvic CT scan
  • Scan only required in patients with a PSA ≥ 40 ng/mL
  • No evidence of bone metastases by bone scan
  • PATIENT CHARACTERISTICS:
  • Life expectancy ≥ 10 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • White blood cell (WBC) \> 3,000/mm\^3
  • Neutrophil count \> 1,500/mm\^3
  • Platelet count \> 100,000/mm\^3
  • Direct bilirubin normal
  • Alanine aminotransferase (ALT) \< 2.0 times upper limit of normal (ULN) (1.5 times ULN if alkaline phosphatase \[AP\] \> 2.5 times ULN)
  • Alkaline phosphatase (AP) \< 4.0 times ULN
  • No other serious medical condition that would preclude study treatment
  • No other malignancy within the past 5 years except nonmelanoma skin cancer
  • No peripheral neuropathy ≥ grade 2
  • No hypersensitivity to drugs formulated with polysorbate 80
  • No significant contraindications to corticosteroids
  • No history of scleroderma
  • No active inflammatory bowel disease (IBD) or IBD that is being medically treated
  • Inclusion of patients with a remote history of IBD is at the discretion of radiotherapist
  • EXCLUSION CRITERIA; PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • No prior therapy for prostate cancer, including any of the following:
  • Conventional hormonal therapy (e.g., orchiectomy, luteinizing hormone-releasing hormone therapy, antiandrogen therapy, or estrogen therapy)
  • External-beam radiotherapy or brachytherapy
  • Cryotherapy
  • Cytotoxic chemotherapy
  • No prior pelvic radiotherapy

Exclusion

    Key Trial Info

    Start Date :

    April 21 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 18 2023

    Estimated Enrollment :

    25 Patients enrolled

    Trial Details

    Trial ID

    NCT00321698

    Start Date

    April 21 2006

    End Date

    August 18 2023

    Last Update

    August 29 2024

    Active Locations (2)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

    Veterans Affairs Medical Center - Portland

    Portland, Oregon, United States, 97207

    2

    OHSU Knight Cancer Institute

    Portland, Oregon, United States, 97239-3098