## Protocol Section
### Identification Module
**NCT ID:** NCT00176579

**Brief Title:** Bone Mineral Density and Cancer Recurrence in Patients With Early Stage Prostate Cancer

**Official Title:** Assessing Bone Mineral Density as a Risk Factor for Early Clinically Significant Prostate Cancer

#### Organization Study ID Info
**ID:** CDR0000539677
#### Organization
**Class:** OTHER
**Full Name:** Rutgers, The State University of New Jersey
#### Secondary ID Infos
**ID:** P30CA072720
**Link:** https://reporter.nih.gov/quickSearch/P30CA072720
**Type:** NIH
**ID:** CINJ-5004
**ID:** CINJ-4375
### Status Module
#### Completion Date
**Date:** 2008-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-08-12

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-08-11

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-07

**Type:** ACTUAL

#### Start Date
**Date:** 2003-06

**Status Verified Date:** 2011-08

#### Study First Post Date
**Date:** 2005-09-15
**Type:** ESTIMATED
**Study First Submit Date:** 2005-09-13
**Study First Submit QC Date:** 2005-09-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Medicine and Dentistry of New Jersey

#### Responsible Party

**Old Name Title:** Stephen Marcella

**Old Organization:** UMDNJ/CINJ

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** RATIONALE: Measuring bone mineral density may help doctors predict whether prostate cancer will come back. It may also help the study of prostate cancer in the future.

PURPOSE: This clinical trial is studying whether bone mineral density affects cancer recurrence in patients with early stage prostate cancer.

**Detailed Description:** OBJECTIVES:

* Determine bone mineral density (BMD) in patients with clinically significant early stage prostate cancer.
* Determine whether patients who have a higher level of BMD and have had a radical prostatectomy for cure are less likely to have an early relapse (i.e., less than 3 years) than those patients with a low level of BMD.

OUTLINE: This is a case-controlled study followed by a prospective, longitudinal, cohort study.

Patients undergo bone mineral density (BMD) measurements by dual-energy x-ray absorptiometry with a densitometer. Posteroanterior measurements of the total hip are also recorded.

Patients also undergo blood collection to examine markers that provide evidence of systemic disease.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

### Conditions Module

**Conditions:**

- Osteoporosis

- Prostate Cancer

**Keywords:**

- osteoporosis

- stage I prostate cancer

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 27

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Dual x-ray absortiometry by densitometer will be performed to measure bone mineral density

**Name:** dual x-ray absorptiometry

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** DXA scan will be done after patient signs consent and eligibilty is confirmed

**Measure:** Bone mineral density

**Time Frame:** Baseline

**Description:** PSA will be measured to look for biochemical recurrence of prostate cancer

**Measure:** Prostate Specific Antigen

**Time Frame:** Baseline, every 6 months for 3 years

### Eligibility Module

**Eligibility Criteria:** DISEASE CHARACTERISTICS:

* Biopsy-confirmed early stage prostate cancer

  * Disease localized within the capsule
  * No evidence of regional or distant spread (i.e., T1-2, N0, M0 disease)
  * A cohort of patients must have undergone a prior radical prostatectomy
* Prostate specific antigen \< 12 ng/mL
* Gleason score ≥ 6

PATIENT CHARACTERISTICS:

* Creatinine clearance ≤ 2.0 mg/dL
* No Paget's disease
* No hyperthyroidism or hypothyroidism
* No Cushing's disease
* No chronic liver disease
* No major health problems that would cause a significant reduction in mobility or activities of daily living

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior bisphosphonates, thyroxin, or calcitonin
* No prior agents that suppress PSA levels (e.g., finasteride)
* No prior androgen or estrogen therapy
* More than 12 months since prior glucocorticoids
* More than 12 months since prior herbal supplements that are known to lower PSA levels

**Maximum Age:** 75 Years

**Minimum Age:** 50 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Subjects will be recruited from urologists' offices and the oncological practices of CINJ. This will be done by verbal communication through the office staff and with the distribution of a brochure briefly describing the study. If a person is interested, he will be given information that briefly describes the study and his name will be taken down. A research assistant will call him and set up a meeting, preferably at the same time he is scheduled to see his physician. At that meeting, a research assistant will go over the consent form with him and cover all questions concerning the study. Eligibility (based on history) will also be verified at this meeting. If he wishes to participate, he will be instructed to sign the consent and an appointment for the blood tests and DXA scan will be arranged.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New Brunswick

**Country:** United States

**Facility:** Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

**State:** New Jersey

**Zip:** 08903

#### Overall Officials

**Official 1:**

**Affiliation:** Rutgers Cancer Institute of New Jersey

**Name:** Stephen W. Marcella, MD, MPH

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### See Also Links

**Label:** Clinical trial summary from Clinicaltrials.gov website

**URL:** http://clinicaltrials.gov/ct2/show/NCT00176579

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005834

- Term: Genital Neoplasms, Male

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000001851

- Term: Bone Diseases, Metabolic

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: HIGH

- As Found: Prostate Cancer

- ID: M12947

- Name: Osteoporosis

- Relevance: HIGH

- As Found: Osteoporosis

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M8946

- Name: Genital Neoplasms, Male

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5130

- Name: Bone Diseases, Metabolic

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011471

- Term: Prostatic Neoplasms

- ID: D000010024

- Term: Osteoporosis

### Misc Info Module

- Version Holder: 2024-05-24
