Conditions

Keywords

osteoporosisadenocarcinoma of the prostatestage IIB prostate cancerstage IIA prostate cancerstage III prostate cancerstage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

Freedom From Any Bone Fracture (FABF) Rate at Three Years
The time of failure was measured from the date of randomization to the date of documented bone fractures, defined as any fracture of the bone. The three-year FABF rate will be estimated by the Kaplan-Meier method.
From randomization to 3 years

Secondary Outcomes (3)

Percent Change in Bone Mineral Density at 3 Years
Baseline, 3 years from start of treatment
Changes in the Functional Assessment of Cancer Therapy-General (FACT-G) at 3 Years
Baseline, 3 years from start of treatment
Utility of the Use of Bisphosphonates as Assessed by Quality-adjusted Survival
From pre-treatment to 3 years from start of treatment

Study Arms (2)

Zoledronic Acid

EXPERIMENTAL

Zoledronic acid q 6 months plus Vitamin D and calcium supplement for 3 years in addition to concurrent radiation therapy and LHRH therapy.

Dietary Supplement: CalciumDietary Supplement: Zoledronic acidRadiation: radiation therapyDrug: LHRHDietary Supplement: Vitamin D

Control

ACTIVE COMPARATOR

Vitamin D and calcium supplement everyday for 3 years in addition to concurrent radiation therapy and LHRH therapy.

Dietary Supplement: CalciumRadiation: radiation therapy

Interventions

CalciumDietary supplement

A single dose of 500 mg of elemental calcium orally each day for 3 years.

ControlZoledronic Acid

Zoledronic acidDietary supplement

Patients receive IV over 15 minutes once every 6 months for 3 years. The goal dose of zoledronic acid is 4 mg, but the selection of dose is determined based on calculated creatinine clearance at baseline.

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Eligibility criteria: * Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of the prostate within 12 months of registration; * Any one of the following clinical stages: * T3 disease, any N stage, M0 with any Gleason score and any prostate-specific antigen (PSA); \< T3 stage, any N stage, M0 with Gleason's score ≥ 8 and any PSA; \< T3 stage, any N stage, M0 with Gleason's score 7 and PSA ≥ 15 nanograms/ml; \< T3 stage, any N stage, M0 with Gleason score \< 7 and PSA ≥ 20 nanograms/ml. * A negative bone scan for metastatic disease; * It is mandatory that the treating physician determine the planned duration of LHRH therapy prior to the site registering the patient (minimum 1 year of therapy); If patient is receiving pre-treatment LHRH therapy, it must have begun ≤ 6 months prior to registration. If pelvic radiation therapy (RT) has started, it must have begun ≤ 8 weeks prior to registration; * Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup to be done within 16 weeks prior to registration: * History/physical examination; * Dental evaluation, including history of dental surgery (e.g., extraction or implant); * Bone scan; * T and L spine films; * DXA scan: To be eligible the patient must have a scan on Lunar, Hologic, or Norland equipment only and the T scores in both the L spine and total hip must be \> negative 2.5; * Zubrod Performance Status 0-1 within 16 weeks prior to registration; (8/16/07) * Age ≥ 18; * Serum creatinine within 4 weeks prior to registration (8/16/07) * Corrected serum calcium ≥ 8.4 and ≤ 10.6 mg/dl within 8 weeks prior to registration; note: for patients with an albumin of 4.0, corrected calcium=measured calcium. The formula for corrected calcium if serum albumin value is above or below 4.0 is as follows: Corrected calcium (mg/dl) = (4 - \[patient's albumin (g/dl)\] x 0.8) + patient's measured calcium (mg/dl) * Patients who are sexually active must be willing/able to use medically acceptable forms of contraception, as the treatment involved in this study may be significantly teratogenic. * Patient agrees to refrain from using all products listed in Section 9.2, "Non-permitted Supportive Therapy"; * Post-prostatectomy patients are eligible. * Patient must sign study specific informed consent prior to study entry. Ineligibility criteria: * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; e.g., carcinoma in situ of the breast or oral cavity are permissible; * Patients with baseline T scores of ≤ -2.5 are excluded. * Patients with baseline calculated creatinine clearance \< 30 mL/min (estimated by Cockcroft-Gault formula below) are excluded. creatinine clearance male = \[(140 - age) x (wt in kg)\] / \[(serum creatinine) x (72)\] * Prior bisphosphonate therapy; * Prior pelvic radiation (other than for current prostate cancer) or prior systemic radiotherapeutic agents, such as strontium or samarium; * Patients receiving systemic chemotherapy, steroids, growth hormones, or calcitonin; * Patients with a history of Paget's disease or with uncontrolled thyroid or parathyroid dysfunction or with other diseases that influence bone metabolism; * Known hypersensitivity to zoledronic acid or other bisphosphonates; * Active dental problems at study entry, including infection of the teeth or jawbone; dental or fixture trauma; or a current or prior diagnosis of osteonecrosis of the jaw, exposed bone in the mouth, or slow healing after dental procedures; * Recent or planned

Sponsors & Collaborators

National Cancer Institute (NCI)
NIHcollaborator
Radiation Therapy Oncology Group
Research networklead

Study Sites (88)

Enloe Cancer Center at Enloe Medical Center

Chico, California, 95926, United States

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center

Pomona, California, 91767, United States

Radiation Oncology Center - Roseville

Roseville, California, 95661, United States

Radiological Associates of Sacramento Medical Group, Incorporated

Sacramento, California, 95815, United States

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, 80933, United States

MeSH Terms

Conditions

OsteoporosisProstatic Neoplasms

Interventions

CalciumZoledronic AcidRadiotherapyGonadotropin-Releasing HormoneVitamin D

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGenital Neoplasms, MaleUrogenital Neoplasms

Limitations and Caveats

This study stopped accrual early due to unmet targeted accrual goals with 109 subjects accrued out of 1272 planned, less than 10% than what was planned.

Results Point of Contact

Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology

Study Officials

Colleen A. Lawton, MD
Medical College of Wisconsin
PRINCIPAL INVESTIGATOR
Matthew R. Smith, MD
Massachusetts General Hospital
STUDY CHAIR
Margaret Chamberlain-Wilmoth, PhD, MSS, RN
Carolinas Medical Center - University
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Zoledronate in Preventing Osteoporosis and Bone Fractures in Patients With Locally Advanced Nonmetastatic Prostate Cancer Undergoing Radiation Therapy and Hormone Therapy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Zoledronic Acid

Control

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (88)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Zoledronic Acid

Control

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (88)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations