Luteinizing Hormone-Releasing Hormone Agonist Therapy and Iodine I 125 Implant in Treating Patients With Previously Untreated Prostate Cancer - Full Text View

Sponsored by:	Jikei University School of Medicine Hospital
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00664456

Purpose

RATIONALE: Androgens can cause the growth of prostate cancer cells. Luteinizing hormone-releasing hormone agonists may lessen the amount of androgens made by the body. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving luteinizing hormone-releasing hormone agonist together with an iodine I 125 implant may be an effective treatment for patients with prostate cancer.

PURPOSE: This randomized phase III trial is studying how well giving luteinizing hormone-releasing hormone agonist therapy together with an iodine I 125 implant works with or without additional luteinizing hormone-releasing hormone agonist therapy in treating patients with previously untreated prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Drug: iodine I 125 Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: releasing hormone agonist therapy	Phase III

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Iodine Cadexomer iodine Gonadorelin Gonadorelin hydrochloride LH-RH

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Phase III, Multicenter, Randomized, Controlled Study of Neoadjuvant LHRH-Agonist Therapy and Permanent I-125 Implantation With vs. Without Adjuvant LHRH-Agonist Therapy in Patients With Untreated Intermediate-Risk Prostate Cancer.

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Biochemical progression-free survival (PFS) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Designated as safety issue: No ]
Clinical PFS [ Designated as safety issue: No ]
Disease-free survival [ Designated as safety issue: No ]
Non-adaptive interval to salvage therapy [ Designated as safety issue: No ]

Estimated Enrollment:	420
Study Start Date:	April 2008
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

To evaluate the biochemical progression-free survival (PFS), overall survival, clinical PFS, and disease-free survival of patients with previously untreated intermediate-risk prostate cancer treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH) agonist therapy and permanent iodine I 125 implantation with vs without adjuvant LHRH agonist therapy.
To determine the non-adaptive interval to salvage therapy in patients treated with these regimens.
To determine the safety of these regimens in these patients.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive neoadjuvant luteinizing hormone-releasing hormone (LHRH) agonist therapy for up to 3 months and undergo permanent iodine I 125 implantation. Patients then receive adjuvant LHRH agonist therapy for up to 9 months.
Arm II: Patients receive neoadjuvant LHRH agonist therapy and undergo permanent iodine I 125 implantation as in arm I.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed prostate cancer
- Previously untreated disease
Intermediate-risk disease, as defined by the following:
- Clinical stage < T2c
- Prostate-specific antigen (PSA) ≤ 20 ng/mL
- Gleason score < 8

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
Life expectancy ≥ 3 months
Leukocyte count ≥ 2,000/uL
Hemoglobin ≥ 10.0 g/dL
Platelet count ≥ 100,000/uL
Serum creatinine ≤ 2.0 mg/dL
ALT and AST ≤ 100 IU/L
No other cancer requiring treatment
No poorly controlled hypertension (i.e., diastolic blood pressure ≥ 120 mm Hg)
No severe psychiatric disorders, including schizophrenia or dementia
No poorly controlled diabetes
Considered appropriate for study participation, as determined by the Principal Investigator or Clinical Investigator

PRIOR CONCURRENT THERAPY:

No prior drugs for benign prostatic hyperplasia (other than antiandrogen therapy)
No prior surgery for prostate cancer
No concurrent steroid drugs (except for ointment)
No other concurrent antiandrogen therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664456

Locations

Japan
Jikei University School of Medicine Hospital	Recruiting
Tokyo, Japan, 125-8506
Contact: Shin Egawa, MD, PhD 81-3-3437-2370

Sponsors and Collaborators

Jikei University School of Medicine Hospital

Investigators

Principal Investigator:

Shin Egawa, MD, PhD

Jikei University School of Medicine Hospital

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000593653, JUSMH-BRI-GU05-01
Study First Received:	April 22, 2008
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00664456
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage II prostate cancer
stage I prostate cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Iodine

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Infective Agents, Local
Neoplasms
Neoplasms by Site
Growth Substances

Therapeutic Uses
Physiological Effects of Drugs
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009