Prostate CancerPhase 2NCT00562315
FACBC PET/CT for Recurrent Prostate Cancer
A Phase 2 study testing FACBC and ProstaScinct in people with Prostate Cancer, run by David M. Schuster, MD at 1 site in United States.
Trial summary
Hypothesis:Anti-[18F]FACBC PET-CT will adequately detect local and extraprostatic recurrence, and lead to better characterization of disease status in restaging patients. This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- FACBC and ProstaScinct
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jul 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be 18 years of age or older.
- Patients will have been originally diagnosed with localized (Stage T1c, T2, or T3 ) prostate carcinoma and have undergone what was considered definitive therapy for localized disease.
- In the case of brachytherapy, cryotherapy, or external beam radiation, treatment will have occurred at least 2 years in the past to eliminate patients with so-called "PSA bump."
- Patient will have suspicion of recurrent prostate carcinoma as defined by: ASTRO criteria of three consecutive rises of PSA or earlier if clinically appropriate, and/or nadir + 2.0 after radiotherapy, and/or greater than 0.3 after prostatectomy.
- Ability to lie still for PET scanning
- Patients must be able to provide written informed consent.
Who cannot join
- Age less than 18.
- Greater than T3 disease in past
- Prior prostatectomy or 2 years since brachytherapy, cryotherapy, or external beam radiation therapy.
- Does not meet above criteria of suspicious PSA elevation
- Inability to lie still for PET scanning
- Cannot provide written informed consent.
- Bone scan findings characteristic for metastatic prostate carcinoma
- Less than 2 months since any prior prostate biopsy (to decrease false positive uptake from inflammation).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 18F-FACBC PET-CT for the Detection and Staging of Recurrent Prostate Carcinoma (CA129356-01).
Hypothesis:Anti-[18F]FACBC PET-CT will adequately detect local and extraprostatic recurrence, and lead to better characterization of disease status in restaging patients.
This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to prostate tissue. The substance is called [18]FACBC and it is given in the form of an injection into a vein. After the substance reaches the prostate, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called [18]FDG is used for PET scans but this substance is eliminated by the kidneys and cannot reach the prostate. This substance called [18]FACBC is not eliminated by the kidneys and may allow tumors in the prostate to be seen better. It is sometimes difficult to tell if a growth on the prostate is cancer with scans or x-rays that are usually done.
Read more
Anti-[18F]FACBC PET-CT will be compared to ProstaScint (In-capromab pendetide) which is the conventional imaging for prostate cancer. Investigators will be blinded of the intervention.
This study will look at how the [18]FACBC goes into the prostate tissue and determine its ability to detect recurrent prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- FACBC, ProstaScinct
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FACBCDrug
Also called Fluciclovine
Anti-3-[18F]FACBC is an investigational positron emission tomography (PET) radiotracer being studies given intravenously prior to PET scan
ProstaScinctOther
Also called In-Capromab Pendetide
ProstaScint (In-Capromab Pendetide) is used to image the extent of prostate cancer in standard practice. Capromab is a mouse monoclonal antibody which recognizes prostate specific membrane antigen from prostate cancer cells and normal prostate tissue. It is given intravenously prior to undergoing CT imaging.
| Study group | Role | What they receive |
|---|---|---|
| FACBC PET-CT and ProstaScint CT | Other | Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer will undergo an FACBC PET-CT scan and the ProstaScinct CT. Receives: Drug: FACBC; Other: ProstaScinct |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With True Positive Scans Within the Prostate Bed
Total number of participants with positive FACBC PET-CT and ProstaScint CT scans in diagnosis of prostate cancer in the prostate bed validated by prostate biopsy and follow up.
Measured: Up to 5 years
Number of Participants With False Positive Scans Within the Prostate Bed
Total number of participants with positive FACBC PET-CT and ProstaScint scans in the prostate bed that were confirmed as negative by biopsy and or follow up.
Measured: Up to 5 years
Number of Participants With True Negative Scans Within the Prostate Bed
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as negative by biopsy and or follow up.
Measured: Up to 5 years
Number of Participants With False Negative Scans Within the Prostate Bed
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as positive by biopsy and or follow up.
Measured: Up to 5 years
Number of Participants With True Positive Scans Outside the Prostate Bed
Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.
Measured: Up to 5 years
Number of Participants With True Negative Scans Outside the Prostate Bed
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.
Measured: Up to 5 years
Number of Participants With False Positive Scans Outside the Prostate Bed
Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.
Measured: Up to 5 years
Number of Participants With False Negative Scans Outside the Prostate Bed
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.
Measured: Up to 5 years
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma
- Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer outside the prostate bed. [total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)]
- Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer outside the prostate bed. [ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)]
- Accuracy = (True positives + true negatives)/all tests
- Positive predictive value = probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed
- Negative predictive value = probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed
Measured: Up to 5 years
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed
- Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives)
- Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives)
- Accuracy = (True positives + true negatives)/all tests
- Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed
- Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed
Measured: Up to 5 years
Secondary outcomes (2)
Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed
- Sensitivity = How well ProstaScint imaging is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives)
- Specificity = How well ProstaScint imaging is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives)
- Accuracy = (True positives + true negatives)/all tests
- Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed
- Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed
Measured: Up to 5 years
Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma
- Sensitivity = How well ProstaScint is able to correctly detect when there is prostate cancer outside the prostate bed. [total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)]
- Specificity = How well ProstaScint is able to correctly detect when there is no prostate cancer outside the prostate bed. [ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)]
- Accuracy = (True positives + true negatives)/all tests
- Positive predictive value = the probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed
- Negative predictive value is the probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed
Measured: 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 posted22 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- David M. Schuster, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, David M. Schuster, MD, Emory University
- Investigators
- David M Schuster, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562315
- Sponsor's protocol ID
- IRB00006468
- Other IDs
- R01CA129356-01
- Status last verified
- Jun 2016
- First submitted
- 20 Nov 2007
- Last updated
- 21 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Schuster DM, Nieh PT, Jani AB, Amzat R, Bowman FD, Halkar RK, Master VA, Nye JA, Odewole OA, Osunkoya AO, Savir-Baruch B, Alaei-Taleghani P, Goodman MM. Anti-3-[(18)F]FACBC positron emission tomography-computerized tomography and (111)In-capromab pendetide single photon emission computerized tomography-computerized tomography for recurrent prostate carcinoma: results of a prospective clinical trial. J Urol. 2014 May;191(5):1446-53. doi: 10.1016/j.juro.2013.10.065. Epub 2013 Oct 19.
PubMed 24144687Schuster DM, Savir-Baruch B, Nieh PT, Master VA, Halkar RK, Rossi PJ, Lewis MM, Nye JA, Yu W, Bowman FD, Goodman MM. Detection of recurrent prostate carcinoma with anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid PET/CT and 111In-capromab pendetide SPECT/CT. Radiology. 2011 Jun;259(3):852-61. doi: 10.1148/radiol.11102023. Epub 2011 Apr 14.
PubMed 21493787Amzat R, Taleghani P, Savir-Baruch B, Nieh PT, Master VA, Halkar RK, Lewis MM, Faurot M, Bellamy LM, Goodman MM, Schuster DM. Unusual presentations of metastatic prostate carcinoma as detected by anti-3 F-18 FACBC PET/CT. Clin Nucl Med. 2011 Sep;36(9):800-2. doi: 10.1097/RLU.0b013e318219b47e.
PubMed 21825855Jani AB, Fox TH, Whitaker D, Schuster DM. Case study of anti-1-amino-3-F-18 fluorocyclobutane-1-carboxylic acid (anti-[F-18] FACBC) to guide prostate cancer radiotherapy target design. Clin Nucl Med. 2009 May;34(5):279-84. doi: 10.1097/RLU.0b013e31819e51e3.
PubMed 19387202
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-FACBC PET-CT for the Detection and Staging of Recurrent Prostate Carcinoma (CA129356-01).
- ClinicalTrials.gov ID
- NCT00562315
- Acronym / sponsor ID
- IRB00006468
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- David M. Schuster, MDUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2007
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 22 Nov 2007 (estimated)
- Results
- Posted 18 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis:Anti-[18F]FACBC PET-CT will adequately detect local and extraprostatic recurrence, and lead to better characterization of disease status in restaging patients.
This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to prostate tissue. The substance is called [18]FACBC and it is given in the form of an injection into a vein. After the substance reaches the prostate, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called [18]FDG is used for PET scans but this substance is eliminated by the kidneys and cannot reach the prostate. This substance called [18]FACBC is not eliminated by the kidneys and may allow tumors in the prostate to be seen better. It is sometimes difficult to tell if a growth on the prostate is cancer with scans or x-rays that are usually done.
Anti-[18F]FACBC PET-CT will be compared to ProstaScint (In-capromab pendetide) which is the conventional imaging for prostate cancer. Investigators will be blinded of the intervention.
This study will look at how the [18]FACBC goes into the prostate tissue and determine its ability to detect recurrent prostate cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FACBC PET-CT and ProstaScint CT | Other | Drug: FACBC, Other: ProstaScinctParticipants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer will undergo an FACBC PET-CT scan and the ProstaScinct CT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must be 18 years of age or older.
- Patients will have been originally diagnosed with localized (Stage T1c, T2, or T3 ) prostate carcinoma and have undergone what was considered definitive therapy for localized disease.
- In the case of brachytherapy, cryotherapy, or external beam radiation, treatment will have occurred at least 2 years in the past to eliminate patients with so-called "PSA bump."
- Patient will have suspicion of recurrent prostate carcinoma as defined by: ASTRO criteria of three consecutive rises of PSA or earlier if clinically appropriate, and/or nadir + 2.0 after radiotherapy, and/or greater than 0.3 after prostatectomy.
- Ability to lie still for PET scanning
Key exclusion criteria (8 listed)
- Age less than 18.
- Greater than T3 disease in past
- Prior prostatectomy or 2 years since brachytherapy, cryotherapy, or external beam radiation therapy.
- Does not meet above criteria of suspicious PSA elevation
- Inability to lie still for PET scanning
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 |
|---|---|---|
| FACBCAlso: FluciclovineAnti-3-[18F]FACBC is an investigational positron emission tomography (PET) radiotracer being studies given intravenously prior to PET scan | Drug | FACBC PET-CT and ProstaScint CT |
| ProstaScinctAlso: In-Capromab PendetideProstaScint (In-Capromab Pendetide) is used to image the extent of prostate cancer in standard practice. Capromab is a mouse monoclonal antibody which recognizes prostate specific membrane antigen from prostate cancer cells and normal prostate tissue. It is given intravenously prior to undergoing CT imaging. | Other | FACBC PET-CT and ProstaScint CT |
Primary outcome
Number of Participants With True Positive Scans Within the Prostate Bed
Time frame: Up to 5 years
Total number of participants with positive FACBC PET-CT and ProstaScint CT scans in diagnosis of prostate cancer in the prostate bed validated by prostate biopsy and follow up.
Number of Participants With False Positive Scans Within the Prostate Bed
Time frame: Up to 5 years
Total number of participants with positive FACBC PET-CT and ProstaScint scans in the prostate bed that were confirmed as negative by biopsy and or follow up.
Number of Participants With True Negative Scans Within the Prostate Bed
Time frame: Up to 5 years
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as negative by biopsy and or follow up.
Number of Participants With False Negative Scans Within the Prostate Bed
Time frame: Up to 5 years
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as positive by biopsy and or follow up.
Number of Participants With True Positive Scans Outside the Prostate Bed
Time frame: Up to 5 years
Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.
Number of Participants With True Negative Scans Outside the Prostate Bed
Time frame: Up to 5 years
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.
Number of Participants With False Positive Scans Outside the Prostate Bed
Time frame: Up to 5 years
Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.
Number of Participants With False Negative Scans Outside the Prostate Bed
Time frame: Up to 5 years
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma
Time frame: Up to 5 years
1. Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer outside the prostate bed. [total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)] 2. Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer outside the prostate bed. [ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)] 3. Accuracy = (True positives + true negatives)/all tests 4. Positive predictive value = probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed 5. Negative predictive value = probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed
Time frame: Up to 5 years
1. Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives) 2. Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives) 3. Accuracy = (True positives + true negatives)/all tests 4. Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed 5. Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed
2 secondary outcomes
Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed
Time frame: Up to 5 years
Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24144687Schuster DM, Nieh PT, Jani AB, Amzat R, Bowman FD, Halkar RK, Master VA, Nye JA, Odewole OA, Osunkoya AO, Savir-Baruch B, Alaei-Taleghani P, Goodman MM. Anti-3-[(18)F]FACBC positron emission tomography-computerized tomography and (111)In-capromab pendetide single photon emission computerized tomography-computerized tomography for recurrent prostate carcinoma: results of a prospective clinical trial. J Urol. 2014 May;191(5):1446-53. doi: 10.1016/j.juro.2013.10.065. Epub 2013 Oct 19.
- Background: PubMed 21493787Schuster DM, Savir-Baruch B, Nieh PT, Master VA, Halkar RK, Rossi PJ, Lewis MM, Nye JA, Yu W, Bowman FD, Goodman MM. Detection of recurrent prostate carcinoma with anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid PET/CT and 111In-capromab pendetide SPECT/CT. Radiology. 2011 Jun;259(3):852-61. doi: 10.1148/radiol.11102023. Epub 2011 Apr 14.
- Background: PubMed 21825855Amzat R, Taleghani P, Savir-Baruch B, Nieh PT, Master VA, Halkar RK, Lewis MM, Faurot M, Bellamy LM, Goodman MM, Schuster DM. Unusual presentations of metastatic prostate carcinoma as detected by anti-3 F-18 FACBC PET/CT. Clin Nucl Med. 2011 Sep;36(9):800-2. doi: 10.1097/RLU.0b013e318219b47e.
- Background: PubMed 19387202Jani AB, Fox TH, Whitaker D, Schuster DM. Case study of anti-1-amino-3-F-18 fluorocyclobutane-1-carboxylic acid (anti-[F-18] FACBC) to guide prostate cancer radiotherapy target design. Clin Nucl Med. 2009 May;34(5):279-84. doi: 10.1097/RLU.0b013e31819e51e3.
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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.
David M Schuster, MD principal investigator
Emory University
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 FACBC and ProstaScinct in people with Prostate Cancer, run by David M. Schuster, MD 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 21 Jun 2016. 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?
Yes. Results are posted in the registry (first posted 18 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With True Positive Scans Within the Prostate Bed (time frame: Up to 5 years). The study lists 10 primary outcomes in all. 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 NCT00562315, 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 21 Jun 2016.