Focal Therapy for Prostate Cancer
Primary Purpose
Prostatic Neoplasms, Prostate Cancer
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brachytherapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Focal therapy, Brachytherapy, Active surveillance, low risk cancer
Eligibility Criteria
Inclusion Criteria:
- Male
- Age >44
- Low risk Prostate Cancer (PSA <10, Gleason 6)
- Low-volume intermediate risk prostate cancer (PSA <15, Gleason 3+4=7)
- Organ confined disease
Exclusion Criteria:
- Metastatic Disease
- Palpable disease bilaterally
- Locally advanced disease either by digital rectal exam or MRI
- PSA >10 (for age <75)
- PSA >15
Sites / Locations
- University of Maryland School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Focal Therapy
Arm Description
Outcomes
Primary Outcome Measures
Transrectal Ultrasound-guided prostate biopsy
Annual prostate biopsy will determine oncological efficacy of treatment of the primary lesion. A standard 12 core biopsy will be performed with an additional 2 cores directed toward the area that was treated. Outcomes will be reported as 1) Presence/absence of cancer in the treated location and 2) Presence of new cancer lesions in other portions of the prostate.
Secondary Outcome Measures
Erectile function
We will evaluate for any change from baseline and subsequent recovery of erectile function. Erectile function will be measured at baseline, then at 3-6 month intervals following treatment using a validated questionnaire, the International Index of Erectile Function (IIEF-5).
Urinary function/bother
We will evaluate the change from baseline and degree of recovery of urinary function using a validated questionnaire, the International Prostate Symptom Score. Incontinence will also be assessed as present/absent and the number of pads used, if any.
Full Information
NCT ID
NCT01802307
First Posted
February 26, 2013
Last Updated
May 6, 2021
Sponsor
University of Maryland, Baltimore
Collaborators
University of Maryland, College Park
1. Study Identification
Unique Protocol Identification Number
NCT01802307
Brief Title
Focal Therapy for Prostate Cancer
Official Title
Focal Therapy for the Treatment of Organ Confined Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study was withdrawn
Study Start Date
February 2013 (Anticipated)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
University of Maryland, College Park
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prostate cancer is the most common solid organ cancer among men and is the second leading cause of cancer death. In 2013 about 238,590 men will be diagnosed with prostate cancer and 29,720 men will die of the cancer. Overall, about 1 in 6 men will be diagnosed with prostate cancer in their lifetime, but only 1 in 36 men will die. Currently, there are over 2.5 million men in the US living with prostate cancer. Standard treatment for prostate cancer has involved either removal of the prostate (radical prostatectomy) or application of some type of energy to the entire prostate gland in order to kill all of the cells--usually with radiation or cryotherapy (freezing).
Over the past decade, it has become apparent that while some men will benefit from treatment for prostate cancer, many will not. Particularly for men with a small amount of low-grade (not very aggressive) type of prostate cancer, the risk of death from this very slow-growing cancer is very low. However, the risk of harm from some of the treatments for prostate cancer is very high. Treatment for prostate cancer can cause erectile dysfunction, urinary leakage, difficulty urinating and overactive bladder and bowel symptoms.
One strategy for men with low risk prostate cancer has been to avoid immediate treatment and wait until the cancer starts to grow. The risk of this strategy is that some men may not be able to be cured once the cancer starts to grow. In addition, men who are on this active surveillance protocol can become very nervous, fearing that the cancer will start to spread.
A new strategy to avoid some of the treatment harms of prostate cancer while also attempting to avoid allowing the cancer to grow is called focal therapy. Many men with low-risk prostate cancer will have only a small piece of cancer within the prostate gland. These men may benefit from treating only this one area instead of the entire prostate. This will allow the physician to kill the cancer cells and to avoid some of the problems associated with treating the entire prostate.
The purpose of this study is to investigate the use of focal, targeted treatment of prostate cancer, that is, to treat only the small area of cancer instead of the entire prostate. We hope to show that this strategy will reduce the amount of side effects without compromising cancer cure.
Detailed Description
Prostate cancer is a lethal disease for ~11% of the men who are diagnosed with it. Early detection of prostate cancer using the PSA blood test can detect cancer a decade or more before it would have been found on a prostate examination. Men who are diagnosed at an older age (>75) may not benefit from aggressive treatment because many will not live long enough for the prostate cancer to kill them. Men who are diagnosed at a young age will be more likely to benefit from treatment from prostate cancer but they will have a very long time to live with some of the side effects of treatment.
Patients with low-risk prostate cancer, which is located in only one area or on one side of the prostate, may benefit from treatment of that one area instead of treating the entire prostate. This is similar to the lumpectomy of breast cancer which removes only the tumor instead of removing the entire breast.
This study will look at the short-term side-effects and the long-term success of performing focal treatment of prostate cancer.
Patients who are newly diagnosed with prostate cancer or who are already diagnosed and on an active surveillance protocol will be considered eligible for consideration of focal therapy. Patients deemed eligible will be offered inclusion in the study. There will only be a treatment group, no controls or placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Prostate Cancer
Keywords
Focal therapy, Brachytherapy, Active surveillance, low risk cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Focal Therapy
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Brachytherapy
Other Intervention Name(s)
Seeds
Primary Outcome Measure Information:
Title
Transrectal Ultrasound-guided prostate biopsy
Description
Annual prostate biopsy will determine oncological efficacy of treatment of the primary lesion. A standard 12 core biopsy will be performed with an additional 2 cores directed toward the area that was treated. Outcomes will be reported as 1) Presence/absence of cancer in the treated location and 2) Presence of new cancer lesions in other portions of the prostate.
Time Frame
yearly up to 5 years
Secondary Outcome Measure Information:
Title
Erectile function
Description
We will evaluate for any change from baseline and subsequent recovery of erectile function. Erectile function will be measured at baseline, then at 3-6 month intervals following treatment using a validated questionnaire, the International Index of Erectile Function (IIEF-5).
Time Frame
every 3-6 months for 5 years
Title
Urinary function/bother
Description
We will evaluate the change from baseline and degree of recovery of urinary function using a validated questionnaire, the International Prostate Symptom Score. Incontinence will also be assessed as present/absent and the number of pads used, if any.
Time Frame
every 3-6 months up to 5 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male
Age >44
Low risk Prostate Cancer (PSA <10, Gleason 6)
Low-volume intermediate risk prostate cancer (PSA <15, Gleason 3+4=7)
Organ confined disease
Exclusion Criteria:
Metastatic Disease
Palpable disease bilaterally
Locally advanced disease either by digital rectal exam or MRI
PSA >10 (for age <75)
PSA >15
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James F Borin, MD
Organizational Affiliation
University of Maryland, College Park
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael J Naslund, MD
Organizational Affiliation
University of Maryland, College Park
Official's Role
Study Chair
Facility Information:
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23265382
Citation
Barret E, Ahallal Y, Sanchez-Salas R, Galiano M, Cosset JM, Validire P, Macek P, Durand M, Prapotnich D, Rozet F, Cathelineau X. Morbidity of focal therapy in the treatment of localized prostate cancer. Eur Urol. 2013 Apr;63(4):618-22. doi: 10.1016/j.eururo.2012.11.057. Epub 2012 Dec 13.
Results Reference
background
PubMed Identifier
23318986
Citation
Klotz L. Active surveillance for prostate cancer: overview and update. Curr Treat Options Oncol. 2013 Mar;14(1):97-108. doi: 10.1007/s11864-012-0221-5.
Results Reference
background
PubMed Identifier
22808955
Citation
Wilt TJ, Brawer MK, Jones KM, Barry MJ, Aronson WJ, Fox S, Gingrich JR, Wei JT, Gilhooly P, Grob BM, Nsouli I, Iyer P, Cartagena R, Snider G, Roehrborn C, Sharifi R, Blank W, Pandya P, Andriole GL, Culkin D, Wheeler T; Prostate Cancer Intervention versus Observation Trial (PIVOT) Study Group. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med. 2012 Jul 19;367(3):203-13. doi: 10.1056/NEJMoa1113162. Erratum In: N Engl J Med. 2012 Aug 9;367(6):582.
Results Reference
background
PubMed Identifier
18792067
Citation
Suardi N, Capitanio U, Chun FK, Graefen M, Perrotte P, Schlomm T, Haese A, Huland H, Erbersdobler A, Montorsi F, Karakiewicz PI. Currently used criteria for active surveillance in men with low-risk prostate cancer: an analysis of pathologic features. Cancer. 2008 Oct 15;113(8):2068-72. doi: 10.1002/cncr.23827.
Results Reference
background
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Focal Therapy for Prostate Cancer
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