Clinical Protocol for the Investigation of the ProSpace™ Balloon System Save

Date Added
November 26th, 2019
PRO Number
Pro00094196
Researcher
David Marshall

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Lymphoma, Men's Health, Prostate
Summary

The ProSpace balloon is being studied to test IF it will temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating that space will reduce the radiation dose delivered to the anterior rectum. The ProSpace balloon is composed of a bioresorbable polymer material called RESOMER. RESOMER is well studied and approved for many indications. This study will show if it will maintain that space for the entire course of prostate radiotherapy treatment and then be completely absorbed by the body over time. The balloon is considered a permanent implant because it will remain in the body for at least 30 days. The ProSpace System study will collect data to demonstrate the safety and efficacy of its indication. This device is currently investigational in the United States

Institution
MUSC
Recruitment Contact
Sarah Mulhern
843-792-9321
hcc-clinical-trials@musc.edu

Randomized Phase II Trial of Niraparib with Standard Combination Radiotherapy and Androgen Deprivation Therapy (ADT) in High Risk Prostate Cancer (with Initial Phase I) Save

Date Added
November 21st, 2019
PRO Number
Pro00094346
Researcher
David Marshall

List of Studies


Profiles_link
Keywords
Cancer/Genitourinary, Prostate
Summary

This subject is for patients with prostate cancer. The purpose is to see if by adding a new drug to usual treatment, can that lower the chance of prostate cancer growing or returning.

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

PHASE III RANDOMIZED TRIAL OF STANDARD SYSTEMIC THERAPY (SST) VERSUS STANDARD SYSTEMIC THERAPY PLUS DEFINITIVE TREATMENT (SURGERY OR RADIATION) OF THE PRIMARY TUMOR IN METASTATIC PROSTATE CANCER Save

Date Added
March 19th, 2019
PRO Number
Pro00086529
Researcher
David Marshall

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Genitourinary, Prostate
Summary

This study is for men who have prostate cancer. The purpose of this study is to compare the effects, good and/or bad, of adding either prostate removal surgery or radiation therapy of the prostate to standard systemic therapy (SST), which is used to treat prostate cancer.

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

Longitudinal Assessment of Financial Burden in Patients with Colon or Rectal Cancer Treated with Curative Intent Save

Date Added
September 6th, 2018
PRO Number
Pro00081552
Researcher
David Marshall

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Gastrointestinal
Summary

Patients will complete questionnaires at 5 time points over 24 months (within 60 days of diagnosis, then at 3, 6, 12 and 24 months after diagnosis). Surveys can be done either on paper or online. It is estimated that it will take 45-60 minutes to complete the first questionnaire and 20-30 minutes to complete the 3, 6, 12 and 24 month questionnaires. Information requested will be about the patient's finances and employment, as well as basic demographic information which will be obtained from the patient's medical records. Patients will be asked to provide their contact information to the ECOG-ACRIN Outcomes and Economics Assessment Unit at Brown University, which will administer the surveys.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
broe@tidelandshealth.org

A Phase II, Double-Blinded, Placebo-Controlled Randomized Trial of Salvage Radiotherapy with or Without Enhanced Anti-Androgen Therapy with Apalutamide in Recurrent Prostate Cancer Save

Date Added
July 18th, 2018
PRO Number
Pro00080775
Researcher
David Marshall

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Genitourinary
Summary

Patients will be randomized to 1 of 2 arms:
ARM 1: Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on Day 1 of radiation therapy, patients receive placebo orally once daily on days 1-30. Treatment repeats every 30 days for up to 6 courses over 6 months in the absence of disease progression or unacceptable toxicity.
ARM 2: Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on Day 1 of radiation therapy, patients receive oral apalutamide on Days 1-30. Treatment repeats every 30 days for up to 6 courses over 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years, and then yearly thereafter.

Institution
MUSC
Recruitment Contact
Nancy McGaha
864-725-7129
nmcgaha@selfregional.org

PHASE III IGRT AND SBRT VS IGRT AND HYPOFRACTIONATED IMRT FOR LOCALIZED INTERMEDIATE RISK PROSTATE CANCER Save

Date Added
February 28th, 2018
PRO Number
Pro00075522
Researcher
David Marshall

List of Studies


Profiles_link
Keywords
Cancer/Genitourinary, Prostate
Summary

This study is for patients with prostate cancer that has a risk of getting worse. The purpose of this study is to compare any good and bad effects of using stereotactic body radiation therapy (SBRT), a technique that gives treatment in a shorter amount of time compared to the usual radiation therapy.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@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

List of Studies


Profiles_link
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
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

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

List of Studies


Profiles_link
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
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@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

List of Studies


Profiles_link
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

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