Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Carcinoma

Prostatic Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

Antineoplastic Agents

All Drugs and Chemicals

Goserelin

H Brasch

Purpose of this study is the evaluation of QoL, tolerability and use of Zoladex 10,8 SafeSystem for advanced PCa under naturalistic conditions

Evaluation of QoL, Tolerability and Use of Zoladex 10,8 SafeSystem for Advanced PCa - German IPEP Trial

Quality Assurance Project in Patients With Advanced Prostate Carcinoma - Evaluation of Tolerability, Quality of Life and Usage of Zoladex 10,8 SafeSystem

AstraZeneca

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Wounds and Injuries

Adenocarcinoma

Osteoporosis

Fractures, Bone

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

Micronutrients

Bone Density Conservation Agents

Vitamins

Mineral

Hormones

Vitamin D

Cholecalciferol

Calcium

Calcium, Dietary

Zoledronic Acid

Trace Elements

Vitamin D3

Calciferol

Calcium Supplement

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

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

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

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.

Zoledronic acid

Patients must receive external beam irradiation, brachytherapy (HDR or LDR), or a combination of external beam irradiation and brachytherapy at the discretion of the treating physician. Dose/duration also will be at the discretion of the treating physician; however, dose will not exceed 45 Gy to 100% of the proximal femur, and no proximal femur will receive ≥ 60 Gy.

radiation therapy

LHRH therapy must take place for a minimum of one year. Choice of LHRH agonist, dose, and duration are at the discretion of the treating physician.

LHRH

400 IU (10μg), orally each day for 3 years.

Colleen A. Lawton, MD

Matthew R. Smith, MD

Margaret Chamberlain-Wilmoth, PhD, MSS, RN

RATIONALE: Zoledronate may prevent bone loss in patients with prostate cancer undergoing radiation therapy and hormone therapy. It is not yet known whether zoledronate is more effective than calcium and vitamin D alone in preventing osteoporosis and bone fractures in patients with prostate cancer.

PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to calcium and vitamin D alone in preventing osteoporosis and bone fractures in patients with locally advanced nonmetastatic prostate cancer undergoing radiation therapy and hormone therapy.

OBJECTIVES:

Primary

* Compare the potential benefit of bisphosphonate therapy comprising zoledronate plus vitamin D and calcium supplement vs standard therapy with vitamin D and calcium supplement in the prevention of osteoporosis and associated bone fractures in patients with locally advanced nonmetastatic adenocarcinoma of the prostate undergoing radiotherapy and luteinizing hormone-releasing hormone (LHRH) agonist therapy.

Secondary

* Evaluate the potential benefit of these regimens on quality of life in these patients.
* Evaluate the potential benefit in bone mineral density over a period of 3 years for patients treated with these regimens.

OUTLINE: This is randomized multicenter study. Patients are stratified according to T score of the hip by dual x-ray absorptiometry (DXA) scan (\< -1.0 but \> -2.5 vs ≥ - 1.0) and planned duration of luteinizing hormone-releasing hormone (LHRH) agonist therapy (1-2½ years vs \> 2½ years). Patients are randomized to 1 of 2 treatment arms.

Quality of life is assessed at baseline and every 6 months during treatment.

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

A Phase III Randomized Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer

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.

Bone mineral density (BMD) was measured by DXA scan (Dual X-ray absorptiometry) for five locations: lumbar, right total hip, left total hip, right femoral neck, and left femoral neck. The percent change at 3 years was calculated for each location by the following formula: Percent Change BMD = (BMD_3 years - BMD_Baseline)/ BMD_Baseline \* 100.

The FACT-G is a validated, 27-item measure. In addition to a total QOL score, subscale scores for physical, functional, social and emotional well-being are produced. There are 5 responses options, with 0=Not a lot and 4=Very much. All items in a subscale are added together, multiplied by the number of items in the subscale, then divided by the number of items answered to obtain subscale totals. Scores range from 0-108 for the FACT-G total score, 0-28 for the physical, social and functional subscales, and 0-24 for the emotional subscale. Certain items, identified on the FACT-G scoring guides, must be reversed before it is added by subtracting the response from 4. All subscale totals are added together to form the FACT-G total score. Each subscale requires at least 50% of the items to be completed while the overall response rate must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicates better QOL.

The EQ-5D is a standardized instrument for measuring generic health status used to generate health utilities, used to derive quality adjusted survival. Quality adjusted survival is computed using the weighted sum of times in different health states added up to a total quality-adjusted survival time. The log-rank test is used to compare quality-adjusted survivals between the treatment arms.

National Cancer Institute (NCI)

Radiation Therapy Oncology Group

Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

Control

Total

Age, Continuous

Sex: Female, Male

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.

Wendy Seiferheld, M.S.

The study is designed to show a 40% relative reduction in the yearly ABF hazard rate, equivalent to an improvement in a 3-year FABF rate from 88% to 92.6%. A sample size of 1030 analyzable patients with a one-sided log-rank test at α = 0.05, was calculated to provide 80% statistical power, with one interim analysis and a final analysis for efficacy using Haybittle-Peto boundaries.

Freedom From Any Bone Fracture (FABF) Rate at Three Years

Lumbar

Hip - Right

Hip - Left

Femoral - Right

Femoral - Left

Eligible patients with baseline and 3-year BMD data at respective location

Percent Change in Bone Mineral Density at 3 Years

Physical Subscale

Social Subscale

Emotional Subscale

Functional Subscale

Eligible patients with baseline and 3-year FACT-G data

Changes in the Functional Assessment of Cancer Therapy-General (FACT-G) at 3 Years

Eligible patients with baseline and follow-up EQ-5D scores, resulting in only 59 patients (no deaths), less than half of enrolled patients (and less than 5% of planned enrollment), which is extremely problematic as it can lead to selection bias, especially with even fewer patients with follow-up scores. Therefore analysis was not conducted.

Utility of the Use of Bisphosphonates as Assessed by Quality-adjusted Survival

Zoledronic acid q 6 months plus Vitamin D and calcium supplement for 3 years in addition to concurrent radiation therapy and luteinizing hormone-releasing hormone (LHRH) therapy.

Overall Study

Vaccines

Androgens

Immunomodulating Agents

Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with a PAP-GM-CSF. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.

Sipuleucel-T

Each dose of APC-Placebo contains approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.

APC-Placebo

Paul Schellhammer, MD

Provenge is an investigational product designed to activate a man's own antigen presenting cells, a type of immune cell, so that they can detect prostate cancer cells and initiate an immune response against them.

Having completed Phase 1 and Phase 2 clinical trials, Provenge is now at the Phase 3 level. One important Phase 3 trial of Provenge has been completed; the current trial is also a Phase 3 study.

If you decide to participate and are eligible, you will be enrolled in the study and randomly assigned to receive either active product or placebo. There are two chances in three that you will receive Provenge. After receiving treatment, you will be monitored at regular intervals until the study endpoints are met. At the end of the trial, men who received placebo will have the opportunity to be treated with active product in another study.

The trial is being conducted at multiple study centers throughout the United States. The trial is a double-blind, placebo-controlled trial. Participants must meet specific eligibility criteria. Study personnel will determine your eligibility in a telephone interview and through routine medical tests (physical exam, blood tests, imaging scans) done at a study center.

If you qualify for and decide to participate in the trial, you will have three product administrations over the course of one month.

Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy

A Randomized, Double Blind, Placebo Controlled Phase 3 Trial of Immunotherapy With Autologous Antigen Presenting Cells Loading With PA2024 (Provenge(R), APC8015) in Men With Metastatic Androgen Independent Prostatic Adenocarcinoma

Time from randomization until death due to any cause.

Measured by imaging studies; confirmed by independent imaging review

Dendreon

Liz Smith

Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.

All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.

All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.

Age Continuous

Age, Customized

Kathleen Picha

Overall Survival

Time to Objective Disease Progression

Symptoms and General Pathology

Hot Flashes

Herbal and Botanical

Prolactin Release-Inhibiting Factors

Angelica

Dong Quai

Angelica Sinensis

Hassan Razvi, MD, FRCSC

Men undergoing androgen deprivation therapy for prostate cancer may experience significant side effects including symptoms of intense heat, facial flushing, and sweating. These so-called hot flashes are similar to those experienced by women during menopause. A traditional Chinese herbal preparation, Dong Quai, has been used for thousands of years to reduce the incidence and severity of hot flashes. Anecdotal evidence exists to support the use of Dong Quai in men treated with androgen deprivation therapy for prostate cancer.

Recently, the awareness and use of herbal remedies and over-the-counter preparations for a number of different conditions have increased dramatically. This trial was, therefore, designed to determine if Dong Quai significantly reduces the incidence and severity of hot flashes in men following androgen deprivation therapy for prostate cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of QoL, Tolerability and Use of Zoladex 10,8 SafeSystem for Advanced PCa - German IPEP Trial	NCT00540059	Prostate Carcin...		-	AstraZeneca
Zoledronate in Preventing Osteoporosis and Bone Fractures in Patients With Locally Advanced Nonmetastatic Prostate Cancer Undergoing Radiation Therapy and Hormone Therapy	NCT00329797	Osteoporosis Prostate Cancer	Calcium Zoledronic acid radiation thera... LHRH Vitamin D	18 Years -	Radiation Therapy Oncology Group
Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy	NCT00065442	Prostate Cancer	Sipuleucel-T APC-Placebo	18 Years -	Dendreon
Angelica Sinensis for the Treatment of Hot Flashes in Men Undergoing LHRH Therapy for Prostate Cancer	NCT00199485	Prostate Cancer	Angelica Sinens...	-	Lawson Health Research Institute

Spots Global Cancer Trial Database for lhrh

Every month we try and update this database with for lhrh cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lhrh

Every month we try and update this database with for lhrh cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lhrh cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.