Prostatic NeoplasmsPhase 2NCT01802307
Focal Therapy for Prostate Cancer
A Phase 2 study testing Brachytherapy in people with Prostatic Neoplasms and Prostate Cancer, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Prostate Cancer
- What is being tested?
- Brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Mar 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Metastatic Disease
- Palpable disease bilaterally
- Locally advanced disease either by digital rectal exam or MRI
- PSA >10 (for age <75)
- PSA >15
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Medicine
Baltimore, Maryland, 21201
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Prostatic Neoplasms, Prostate Cancer
- Being tested
- Brachytherapy
- Keywords
- Focal therapy, Brachytherapy, Active surveillance, low risk cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrachytherapyRadiation
Also called Seeds
| Study group | Role | What they receive |
|---|---|---|
| Focal Therapy | Experimental | Not described Receives: Radiation: Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: yearly up to 5 years
Secondary outcomes (2)
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).
Measured: every 3-6 months for 5 years
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.
Measured: every 3-6 months up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startFeb 2013 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Why it stopped: Study was withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, College Park
- Responsible party
- Sponsor
- Investigators
- James F Borin, MD, Principal investigator, University of Maryland, College ParkMichael J Naslund, MD, Study chair, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802307
- Sponsor's protocol ID
- HP-00054478
- Status last verified
- May 2021
- First submitted
- 26 Feb 2013
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23265382Klotz 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.
PubMed 23318986Wilt 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.
PubMed 22808955Suardi 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.
PubMed 18792067
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal Therapy for the Treatment of Organ Confined Prostate Cancer
- ClinicalTrials.gov ID
- NCT01802307
- Acronym / sponsor ID
- HP-00054478
- Conditions
- Prostatic Neoplasms, Prostate Cancer
- Keywords
- Focal therapy, Brachytherapy, Active surveillance, low risk cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- University of Maryland, College Park
- Study start
- Feb 2013 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focal Therapy | Experimental | Radiation: Brachytherapy |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Metastatic Disease
- Palpable disease bilaterally
- Locally advanced disease either by digital rectal exam or MRI
- PSA >10 (for age <75)
- PSA >15
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrachytherapyAlso: Seeds | Radiation | Focal Therapy |
Primary outcome
Transrectal Ultrasound-guided prostate biopsy
Time frame: yearly up to 5 years
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.
2 secondary outcomes
Erectile function
Time frame: every 3-6 months for 5 years
Urinary function/bother
Time frame: every 3-6 months up to 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Background: PubMed 23265382Barret 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.
- Background: PubMed 23318986Klotz 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.
- Background: PubMed 22808955Wilt 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.
- Background: PubMed 18792067Suardi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James F Borin, MD principal investigator
University of Maryland, College Park
Michael J Naslund, MD study chair
University of Maryland, College Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brachytherapy in people with Prostatic Neoplasms and Prostate Cancer, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transrectal Ultrasound-guided prostate biopsy (time frame: yearly up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01802307, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.