Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Hypertrophy

Prostatic Hyperplasia

Urinary Bladder Calculi

Kidney Calculi

Calculi

Nephrolithiasis

Hyperplasia

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Pathological Conditions, Anatomical

Kidney Diseases

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urolithiasis

Urinary Calculi

Urinary Bladder Diseases

Comprised of men with biopsy-confirmed PCa who are scheduled for prostatectomy.

comprosed of men with benign prostatic hypertrophy (BPH) who are scheduled for transurethral resection of the prostate (TURP).

Comprised of men or women with bladder/kidney stones who are scheduled for a cystoscopy.

The NV-VPAC1 PCa Urine Diagnostic Test is intended for use by clinicians to detect the presence of prostate cancer cells shed in voided urine of men at risk for prostate cancer.

NV-VPAC1 PCa Urine Diagnostic Test

Jay Bishoff, MD

This is a double-blind, study to evaluate the performance of NV-VPAC1 PCa Urine Diagnostic Test in three distinct populations being treated at the Intermountain Urology Clinic. The first population (positive control) is comprised of men with biopsy-confirmed PCa who are scheduled for prostatectomy. The second population (negative control) is comprised of men with benign prostatic hypertrophy (BPH) who are scheduled for transurethral resection of the prostate (TURP). The third population (negative control) is comprised of men or women with bladder/kidney stones who are scheduled for a cystoscopy.

Evaluation of the NV-VPAC1 Prostate Cancer (PCa) Urine Diagnostic Test in Subjects With Biopsy-confirmed Prostate Cancer, Benign Prostatic Hypertrophy, or Bladder/Kidney Stones.

Evaluation of the NV-VPAC1 Prostate Cancer (PCa) Urine Diagnostic Test in Subjects With Biopsy-confirmed Prostate Cancer, Benign Prostatic Hypertrophy, or Bladder/Kidney Stones

Degree of association of the presence of orange fluorescent positive cells shed in voided urine of men with biopsy-proven PCa and lack of association of orange fluorescent positive cells in men diagnosed with BPH or in individuals with bladder/kidney stones

NuView Diagnostics

Intermountain Health Care, Inc.

Director of Intermountain Urological Institute

All Drugs and Chemicals

Androgens

Patients treated for prostatic pathology (benign or malign)in the hospital department.

Urine specimens collected by vesical catheterism just before surgery. The dosage of PCA-3 and the analyse of several prostatic markers (genes coding for androgen receptor and steroid alpha-reductase type 1 and 2) will be realized on the samples of urines.

Taking of urines

Cyrille BASTIDE

Nowadays, prostate cancer screening is largely widespread although it is not recommended yet. This screening includes primarily digital rectal examination and PSA.

Recently, a new specific genetic marker of prostate cancer has been discovered. It is PCA-3 gene.

The main objective is to evaluate prospectively this new marker in patients treated for prostatic pathology (benign or malign) in the department.

Nowadays, prostate cancer screening is largely widespread although it is not recommended yet. This screening includes primarily digital rectal examination and PSA.

The main drawback is the poor PSA specificity. Prostate cancer diagnosis is only histologic diagnosis (mainly by prostate biopsies). However, prostate needle biopsies have a poor rentability and are negative in 60 to 80%. Recently, a new specific genetic marker of prostate cancer has been discovered. It is PCA-3 gene. This gene encodes for RNAm noncoding. So, RNA expression must be assayed by RT-PCR. The main objective is to evaluate prospectively this new marker in patients treated for prostatic pathology (benign or malign) in the department.

PCA-3 assay will be made from urine specimens collected by vesical catheterism just before surgery. Moreover, the investigators will analyse expression of several prostatic markers (genes coding for androgen receptor and steroid alpha-reductase type 1 and 2). The main objective is to improve the prostate cancer diagnosis specificity. Gene expression will be assayed by RT-PCR.

Prostatic cells in urine specimens will be confirmed by assay of PSA gene expression. Normalization of data will be performed using 3 housekeeping genes expression (ß-actin, K-a-1 tubulin and Glyceraldehyde-3-phosphate).

The originality of this clinical study compared to previous reports, consists to two elements. Firstly, all patients included in our study will be operated for a prostate cancer or a BPH. So, the risk to ignore a prostate cancer will be low unlike prostate biopsies made for a prostate cancer screening. Secondly, PCA-3 assay will be coupled with others prostatic specific markers.

Prostate Cancer Antigen 3 (PCA-3) Gene Project

PCA-3 Gene Project

Assistance Publique Hopitaux De Marseille

Behaviors and Mental Disorders

Erectile Dysfunction

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Group contains men with physician-diagnosed erectile dysfunction

Men 50 years and older having no ED and pre-existing prostate cancer

Men 50 years old older with symptomatic prostatic hypertrophy but with no ED nor pre-existing prostate cancer

Patients with ED are considered belonging to the exposure group.

Erectile dysfunction

Victor C Kok, MD, PhD

The rationale for investigating the hypothesis that there is an association between erectile dysfunction (ED) and the subsequent development of prostate cancer is based on three assumptions: 1) baseline ED is common in most if not all of the cross-sectional studies in men with prostate cancer; 2) the development of ED and prostate cancer may have certain shared common risk factors; and 3) the use of testosterone for the treatment of ED has been suspected to be associated with prostate cancer development. Controversy exists over whether men with ED have an increased risk of subsequent prostate cancer. Few studies have evaluated the risk of developing prostate cancer for men with ED. The investigators, therefore, conducted a population-based longitudinal study with eight years' follow-up to examine this association and to evaluate the magnitude of the risk.

Will Erectile Dysfunction Increase the Risk of Prostate Cancer

Erectile Dysfunction and the Future Risk of Prostate Cancer: a Population-based Longitudinal Follow-up Study With Concurrent Double Comparison Cohorts

Asia University

National Central University, Taiwan

Kuang Tien General Hospital

Ass. Professor

Men in this arm have chosen brachytherapy for management of localized prostate cancer and do not require androgen ablation for oncologic reasons but have an enlarged prostate causing pubic arch interference and thus require prostate size reduction prior to brachytherapy. They will have 2-3 months of Degarelix with measurement of prostate volume at 8 and 12 weeks.

Men in this arm have higher risk prostate cancer (upper tier intermediate risk by National Comprehensive Cancer Network \[NCCN\] guidelines) and require 6 months of androgen ablation in conjunction with brachytherapy. Prostate size must be \> 40 cc at baseline so that prostate size reduction measurements are appropriate. Prostate measurements by transrectal ultrasound with be taken at 12 weeks and 20 weeks.

240 mg loading dose followed by monthly 80 mg maintenance dose for 2-3 months

Degarelix

240 mg loading dose of Degarelix followed by 80 mg maintenance doses every month for a total duration of 6 months.

Juanita M Crook, MD

This study will investigate the efficacy of Degarelix, a Luteinizing Hormone Releasing Hormone (LHRH) antagonist, to reduce prostate volume prior to permanent seed prostate brachytherapy. There are 2 eligible populations of men, all of whom will have selected brachytherapy as their treatment of choice for their prostate cancer. Either they have an enlarged prostate that requires size reduction to render brachytherapy technically feasible, or they require androgen ablation in conjunction with brachytherapy for optimal tumor control. The hypothesis is that Degarelix will provide \> 30% volume reduction by 3 months in \> 30% of men.

All men will have a baseline transrectal ultrasound for brachytherapy planning that has demonstrated an enlarged prostate with or without pubic arch obstruction. After signing the informed consent document they will have a loading dose of 240 mg Degarelix and then monthly maintenance dose injections of 80 mg until such time as sufficient prostate reduction has occured (2-3 months) or they complete the 6 months of required androgen ablation for their disease status.

Feasibility and Toxicity of Degarelix for Prostate Downsizing Prior to Permanent Seed Prostate Brachytherapy

Phase II Trial Assessing the Feasibility and Toxicity of Degarelix in Achieving Prostate Downsizing Prior to Treatment With Permanent Seed Prostate Brachytherapy

determined by transrectal ultrasound with planimetry volume calculation

Luteinizing Hormone(LH), Follicle Stimulating Hormone (FSH) and testosterone will be measured at 1, 3, 6, 9 and 12 months following cessation of Degarelix.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of the NV-VPAC1 Prostate Cancer (PCa) Urine Diagnostic Test in Subjects With Biopsy-confirmed Prostate Cancer, Benign Prostatic Hypertrophy, or Bladder/Kidney Stones.	NCT03630926	Prostate Cancer Benign Prostati... Bladder Stones Kidney Stones	NV-VPAC1 PCa Ur...	18 Years - 80 Years	Intermountain Health Care, Inc.
Prostate Cancer Antigen 3 (PCA-3) Gene Project	NCT01177436	Prostate Cancer Benign Prostati...	Taking of urine...	18 Years -	Assistance Publique Hopitaux De Marseille
Prostate Cancer Antigen 3 (PCA-3) Gene Project	NCT01177436	Prostate Cancer Benign Prostati...	Taking of urine...	18 Years -	Assistance Publique Hopitaux De Marseille
Will Erectile Dysfunction Increase the Risk of Prostate Cancer	NCT03009123	Erectile Dysfun...	Erectile dysfun...	50 Years - 99 Years	Kuang Tien General Hospital
Feasibility and Toxicity of Degarelix for Prostate Downsizing Prior to Permanent Seed Prostate Brachytherapy	NCT01446991	Prostate Cancer	Degarelix Degarelix	40 Years - 80 Years	British Columbia Cancer Agency

Spots Global Cancer Trial Database for benign prostatic hypertrophy