Focal Therapy for Prostate Cancer
| Status: | Withdrawn |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 4/21/2018 |
| Start Date: | February 2013 |
| End Date: | March 2018 |
Focal Therapy for the Treatment of Organ Confined Prostate Cancer
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.
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.
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.
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.
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
We found this trial at
1
site
655 West Baltimore Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
(410) 706-7410
University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
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