Phase 1b Study of Metformin Plus Oligomeric Procyanidin Complex for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Save

Date Added
October 17th, 2017
PRO Number
Pro00071159
Researcher
Michael Lilly
Keywords
Prostate
Summary

The purpose of this study is to identify safe pharmaceutical agents that can reduce the AGE levels in subjects with advanced cancer. The term ?AGE? (advanced glycation endpoints) refers to sugar-derived metabolites that are linked to lifestyle choices and can contribute to cancer.

Institution
MUSC
Recruitment Contact
Michael Wheeler
792-0592
wheelerm@musc.edu

A Phase II Trial of Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse after Radical Prostatectomy Save

Date Added
May 24th, 2016
PRO Number
Pro00054476
Researcher
Michael Lilly
Keywords
Cancer/Genitourinary, Prostate, Vaccine
Summary

This study is for adult male patients who have recently undergone radical prostatectomy and are at high risk for relapse. The purpose of this study is to look at the effect PROSTVAC-V/F has in preventing or prolonging relapse after surgery. PROSTVAC-V/F is an investigational drug. Subjects will have screening tests to determine eligibility. If the subject is eligible and wishes to enroll, he will begin study drug and will have drug administered at designated intervals over about 20 weeks . After the 20 week period, the subject will enter a follow up period for about a year and a half. The total amount of time on study is anticipated to be about 2 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-cto-clinops@musc.edu

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer. Save

Date Added
April 28th, 2014
PRO Number
Pro00034803
Researcher
Michael Lilly
Keywords
Cancer/Genitourinary, Prostate
Summary

This study is for patients that have prostate cancer that has spread and are either beginning hormone therapy for the first time or have been on hormone therapy for less than 30 days. The purpose of this study is to find out what effects (good and/or bad) there are to adding the new investigational drug TAK-700 (also called orteronel) to standard hormone therapy which is used to treat prostate cancer as compared to the standard of hormone therapy alone. The combination of TAK-700 and standard hormone therapy is considered experimental.

Institution
MUSC
Recruitment Contact
Seth Price
843-792-1918
pricesr@musc.edu

Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High-Risk Prostate Cancer: A Phase III Randomized Trial Save

Date Added
September 17th, 2013
PRO Number
Pro00028856
Researcher
David Marshall
Keywords
Cancer, Cancer/Genitourinary, Prostate
Summary

The purpose of this study is to compare the effects of hormone therapy (androgen deprivation) and radiation therapy to the prostate gland and seminal vesicles with hormone therapy and radiation therapy to the whole pelvic body area to determine which is better.

There are 2 treatment groups in this study:
1) Patients who receive hormone therapy plus radiation therapy to the prostate gland and seminal vesicles
2) Patients who receive hormone therapy plus radiation therapy to the whole pelvis

Institution
MUSC
Recruitment Contact
Kelly Hawthorne
864-725-4111
khawthorne@selfregional.org

A Phase III Prospective Randomized Trial Of Dose-Escalated Radiotherapy With Or Without Short-Term Androgen Deprivation Therapy For Patients With Intermediate-Risk Prostate Cancer Save

Date Added
August 19th, 2013
PRO Number
Pro00027510
Researcher
David Marshall
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Prostate
Summary

This study is for patients with prostate cancer. The purpose of this study is to compare the effects of dose-escalated radiation therapy with or without hormone therapy on your prostate cancer.
There are 2 treatment groups in this study:
1) Patients who receive radiation therapy only
2) Patients who receive radiation therapy plus hormone therapy
Patients will receive 44 radiation treatments over approximately 2 months. If the patient chooses to receive the brachytherapy implant, he will receive 25 daily treatments plus the implant procedure over a timeframe of approximately 6 weeks. Hormone therapy, if given, will last 6 months. After patients are finished receiving therapy, the study doctor will ask them to visit the office for follow-up exams at 3, 6, 9, and 12 months after finishing radiation treatment, every 6 months for 4 years, and yearly thereafter.

Institution
MUSC
Recruitment Contact
Seth Price
843-792-6969
pricesr@musc.edu

Phase III Trial of Dose Escalated Radiation Therapy and Standard Androgen Deprivation Therapy (ADT) with a GnRH Agonist vs. Dose Escalated Radiation Therapy and Enhanced ADT with a GnRH Agonist and TAK-700 for Men with High Risk Prostate Cancer Save

Date Added
October 2nd, 2012
PRO Number
Pro00018969
Researcher
David Marshall
Keywords
Cancer, Prostate
Summary

The purpose of this study is to compare the effects of hormone therapy (androgen deprivation) and TAK-700 plus radiation therapy with hormone therapy (androgen deprivation) and radiation therapy on patients with prostate cancer.
There are 2 treatment groups in this study. Group 1will receive hormone therapy plus radiation therapy only and Group 2 will receive hormone therapy and TAK-700 plus radiation therapy.
Subjects will receive hormone therapy for 24 months. Radiation will be given in 44 treatments over approximately 2 months. If the subject is in Group 2 they will take TAK-700 for 24 months. After the subject is finished receiving therapy, the study doctor will ask the subject to visit the office for follow-up exams every 6 months for 3 years and then once a year.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-9007
brisend@musc.edu

Vitamin D3 Supplementation for Low-Risk Prostate Cancer, A Randomized Trial Save

Date Added
September 18th, 2012
PRO Number
Pro00019745
Researcher
Stephen Savage
Keywords
Cancer, Prostate, Vitamin D
Summary

This randomized clinical trial will enroll 136 men recently diagnosed with Early-Stage prostate cancer. Men must be 19 or older with a prostate biopsy Gleason score ? 6 and PSA ?10 who have decided that active surveillance is their present treatment option. Study visits will be every 4 months for just over a year in Charleston, S.C. There will be two groups, one taking vitamin D3 supplement and the other taking a placebo. Assigment to each group will be by chance and neither the particpant nor the study team will know to which group they are assigned. Blood and urine samples will be collected at each visit for research purposes. A survey relating to the subjects' decision making about their biopsies will be completed at the baseline and final visits. Waist/hip ratio and blood pressure measurements will also be obtained at the baseline and final study visits. Each participant will be in the study until a repeat prostate biopsy is performed by their own Urologist as Standard of Care for Active Surveillance regimen.

Institution
MUSC
Recruitment Contact
Linda Ambrose
843-792-8303
ambrosel@musc.edu

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