Prostate CancerPhase 2ReCAPNCT00583492
Randomized Trial of Suicide Gene Therapy and Prostate Cancer
A Phase 2 study testing Ad5-yCD/mutTKSR39rep-ADP and IMRT in people with Prostate Cancer, run by Henry Ford Health System at 2 sites in United States.
Trial summary
This is a randomized, controlled trial that will test the hypothesis that replication-competent adenovirus-mediated suicide gene therapy in combination with 80 Gy intensity modulated radiotherapy (IRMT)will improve freedom from failure (FFF) relative to 80 Gy IMRT alone in patients with newly-diagnosed prostate cancer… 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?
- Ad5-yCD/mutTKSR39rep-ADP and IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2007to Sep 2013
- 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
- Men with histologically-confirmed adenocarcinoma of the prostate within 180 days prior to registration. To be eligible, the subjects must have one of the following conditions:
- Stage T1 or T2, Gleason Score 7, PSA <= 20 ng/mL, Any number positive biopsy cores
- Stage T1 or T2, Gleason Score 5 or 6, PSA >=10 ng/mL and <20 ng/mL, Any number positive biopsy cores
- Stage T1 or T2, Gleason Score 5 or 6, PSA <10 ng/mL and >=50% positive biopsy cores
- Negative lymph nodes as established by imaging, nodal sampling, or dissection within 90 days prior to registration.
- No evidence of metastatic disease as evaluated by bone scan and CT scan of the abdomen and pelvis within 90 days prior to registration
Show all 16Show fewer
- Karnofsky performance status >=70
- Subjects must have adequate baseline organ function, as assessed by the following laboratory values, within 30 days before initiating the study
- Adequate renal function with serum creatinine <=1.5 mg/dL or creatinine clearance >=45 mL/min/m2.
- Platelet count > 100,000/μL.
- Absolute neutrophil count > 1,000/μL.
- Hemoglobin > 10.0 g/dL.
- Normal partial thromboplastin time (PTT) and prothrombin (PT).
- Bilirubin < 1.5 mg/dL; SGOT and SGPT < 2.5 times upper limit of normal (ULN).
- Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards.
- Subjects must possess the ability to give informed consent and express a willingness to meet all of the expected requirements of the protocol for the duration of the study.
Who cannot join
- Subjects with the following conditions will be excluded from the study:
- Stage >= T3.
- Prostate specific antigen (PSA) > 20 ng/mL.
- Gleason score >= 8.
- Prostate volume >120cc.
- Pathologically positive lymph nodes or nodes > 1.5 cm on imaging. Note: nodes > 1.5 cm but biopsy negative are allowed.
Show all 22Show fewer
- Evidence of M1 metastatic disease.
- Prior invasive malignancy except for non-melanoma skin cancer within 5 years of enrollment.
- Prognosis for survival of < 5 years.
- Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason.
- Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation fields.
- Prior or planned androgen suppression therapy or prior systemic chemotherapy for the study cancer. Note that prior chemotherapy for a different cancer is allowed; however, patients must be >2 years post-completion of chemotherapy at time of registration. Patients on Proscar therapy must stop to be eligible.
- Severe, active co-morbidity defined as:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
- Transmural myocardial infarction within the last 6 months.
- Acute infection. Acute infection is defined by any viral, bacterial, or fungal infection that requires specific therapy within 72 hours of initiation of the study therapy.
- Positive serological test for HIV at baseline.
- Previous history of liver disease including hepatitis.
- Immunosuppressive therapy including systemic corticosteroids. Use of inhaled and topical corticosteroids is permitted.
- Impaired immunity or susceptibility to serious viral infections.
- Allergy to any product used in the protocol. (If the subject has an allergy to Ciprofloxacin, another antibiotic can be substituted at the discretion of the treating physician.
- Serious medical or psychiatric illness or concomitant medication, which, in the judgment of the principal investigator, might interfere with the subject's ability to respond to or tolerate the treatment or complete the trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21231
Henry Ford Health System
Detroit, Michigan, 48202
About this study
Official title: A Randomized, Controlled Trial of Replication-Competent Adenovirus-Mediated Suicide Gene Therapy in Combination With IMRT Versus IMRT Alone for the Treatment of Newly-Diagnosed Prostate Cancer With an Intermediate Risk Profile
This is a randomized, controlled trial that will test the hypothesis that replication-competent adenovirus-mediated suicide gene therapy in combination with 80 Gy intensity modulated radiotherapy (IRMT)will improve freedom from failure (FFF) relative to 80 Gy IMRT alone in patients with newly-diagnosed prostate cancer with an intermediate-risk profile.
Read the detailed description
OBJECTIVES
This is a randomized, controlled trial that will test the hypothesis that replication-competent adenovirus-mediated suicide gene therapy in combination with 80 Gy intensity modulated radiotherapy (IRMT)will improve freedom from failure (FFF) relative to 80 Gy IMRT alone in patients with newly-diagnosed prostate cancer with an intermediate-risk profile.
The trial contains two treatment arms:
Arm 1- Gene Therapy + IMRT Arm 2- IMRT
The study will be stratified by clinical site and pre-treatment risk factors (e.g., % positive biopsy cores, Gleason score.
- Gleason score 5/6 AND PSA <10 ng/mL; AND >=50% positive biopsy cores
- (Gleason score 5/6 and PSA 10-20 ng/mL) OR (Gleason score 7 and PSA 0 - 20 ng/mL); AND <50% positive biopsy cores
- Gleason score 5/6 and PSA 10-20 ng/mL) OR (Gleason score 7 and PSA 0-20 ng/mL) AND >=50% positive biopsy cores.
An interim safety analysis (Interim Analysis 1) will be conducted after the first 21 patients in the investigational therapy arm, and a total of 42 subjects in both arms, have completed the 90 day toxicity assessment following randomization (phase 2 component). If, at this point, there are no safety concerns as determined by the Data and Safety Monitoring Board (DSMB), the trial will continue as a phase 3 study with two additional interim analyses (Interim Analyses 2 \& 3). The primary analysis for treatment efficacy will be based on all randomized subjects.
Primary
To assess the relative efficacy of replication-competent adenovirus-mediated suicide gene therapy in combination with 80 Gy intensity modulated radiotherapy (IMRT) versus 80 Gy IMRT alone in patients with newly-diagnosed prostate cancer with an intermediate-risk profile. The primary endpoint is freedom from failure (FFF) (biochemical or clinical).
Secondary
To assess the difference between the two treatment arms for:
- Acute (<= 90 days) and long-term (> 90 days) toxicity.
- Prostate biopsy status (12 cores) at 2 years.
- Freedom from distant metastases.
- Disease-specific and overall survival.
- Quality of life.
Exploratory
To examine:
- Possible effect of gene therapy on PSA doubling time (PSADT) after PSA failure.
- Possible association between the primary and secondary outcomes and Ad5-yCD/mutTKSR39rep-ADP adenovirus persistence (as measured by adenoviral DNA in blood).
- Possible association between the primary and secondary outcomes and specific immunological endpoints including levels of circulating CD4+ and CD8+ T lymphocytes, T-cell proliferation response, cytotoxic T lymphocyte (CTL) response, and development of antibodies to prostate-specific antigens.
- Conditions
- Prostate Cancer
- Being tested
- Ad5-yCD/mutTKSR39rep-ADP, IMRT
- Keywords
- Prostatic Neoplasms, Prostate Cancer, Adenocarinomas, Tumors of the Prostate, Gene Therapy, IMRT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad5-yCD/mutTKSR39rep-ADPBiological
Ad5-yCD/mutTKSR39rep-ADP (1 x 10^12 vp) on day 1 Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy
IMRTRadiation
40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy
| Study group | Role | What they receive |
|---|---|---|
| Ad5-yCD/mutTKSR39rep-ADP + IMRT | Experimental | Gene Therapy + IMRT Receives: Biological: Ad5-yCD/mutTKSR39rep-ADP |
| IMRT Alone | Active comparator | IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Receives: Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Biochemical/Clinical Failure (FFF)
Biochemical/Clinical Failure was defined as PSA nadir plus 2 ng/mL
Measured: 5 years
Secondary outcomes (5)
Acute >= Grade 3 Treatment-related Toxicity
This metric includes both expected and unexpected events Toxicities were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3
Measured: 90 days
Positive Prostate Biopsy at 2 Years
Measured: 2 years
Freedom From Distant Metastases
Measured: 10 years
Disease-specific Survival
Measured: 10 years
Decrease in Quality of Life
Quality of Life was measured using the comprehensive Expanded Prostate Cancer Index Composite (EPIC) instrument 19 and 20
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionSep 2013
- Study completionSep 2013
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 (5)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Movsas, M.D., Henry Ford Health System
- Investigators
- Benjamin Movsas, M.D., Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583492
- Sponsor's protocol ID
- Prostate4809
- Acronym
- ReCAP
- Status last verified
- Feb 2016
- First submitted
- 20 Dec 2007
- Last updated
- 17 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Freytag SO, Khil M, Stricker H, Peabody J, Menon M, DePeralta-Venturina M, Nafziger D, Pegg J, Paielli D, Brown S, Barton K, Lu M, Aguilar-Cordova E, Kim JH. Phase I study of replication-competent adenovirus-mediated double suicide gene therapy for the treatment of locally recurrent prostate cancer. Cancer Res. 2002 Sep 1;62(17):4968-76.
PubMed 12208748Freytag SO, Stricker H, Peabody J, Pegg J, Paielli D, Movsas B, Barton KN, Brown SL, Lu M, Kim JH. Five-year follow-up of trial of replication-competent adenovirus-mediated suicide gene therapy for treatment of prostate cancer. Mol Ther. 2007 Mar;15(3):636-42. doi: 10.1038/sj.mt.6300068. Epub 2007 Jan 16.
PubMed 17228316Freytag SO, Stricker H, Pegg J, Paielli D, Pradhan DG, Peabody J, DePeralta-Venturina M, Xia X, Brown S, Lu M, Kim JH. Phase I study of replication-competent adenovirus-mediated double-suicide gene therapy in combination with conventional-dose three-dimensional conformal radiation therapy for the treatment of newly diagnosed, intermediate- to high-risk prostate cancer. Cancer Res. 2003 Nov 1;63(21):7497-506.
PubMed 14612551Freytag SO, Movsas B, Aref I, Stricker H, Peabody J, Pegg J, Zhang Y, Barton KN, Brown SL, Lu M, Savera A, Kim JH. Phase I trial of replication-competent adenovirus-mediated suicide gene therapy combined with IMRT for prostate cancer. Mol Ther. 2007 May;15(5):1016-23. doi: 10.1038/mt.sj.6300120. Epub 2007 Mar 20.
PubMed 17375076Freytag SO, Stricker H, Lu M, Elshaikh M, Aref I, Pradhan D, Levin K, Kim JH, Peabody J, Siddiqui F, Barton K, Pegg J, Zhang Y, Cheng J, Oja-Tebbe N, Bourgeois R, Gupta N, Lane Z, Rodriguez R, DeWeese T, Movsas B. Prospective randomized phase 2 trial of intensity modulated radiation therapy with or without oncolytic adenovirus-mediated cytotoxic gene therapy in intermediate-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2014 Jun 1;89(2):268-76. doi: 10.1016/j.ijrobp.2014.02.034. Epub 2014 May 5.
PubMed 24837889
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of Replication-Competent Adenovirus-Mediated Suicide Gene Therapy in Combination With IMRT Versus IMRT Alone for the Treatment of Newly-Diagnosed Prostate Cancer With an Intermediate Risk Profile
- ClinicalTrials.gov ID
- NCT00583492
- Acronym / sponsor ID
- ReCAP / Prostate4809
- Conditions
- Prostate Cancer
- Keywords
- Prostatic Neoplasms, Prostate Cancer, Adenocarinomas, Tumors of the Prostate, Gene Therapy, IMRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 31 Dec 2007 (estimated)
- Results
- Posted 17 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, controlled trial that will test the hypothesis that replication-competent adenovirus-mediated suicide gene therapy in combination with 80 Gy intensity modulated radiotherapy (IRMT)will improve freedom from failure (FFF) relative to 80 Gy IMRT alone in patients with newly-diagnosed prostate cancer with an intermediate-risk profile.
Detailed description
OBJECTIVES
This is a randomized, controlled trial that will test the hypothesis that replication-competent adenovirus-mediated suicide gene therapy in combination with 80 Gy intensity modulated radiotherapy (IRMT)will improve freedom from failure (FFF) relative to 80 Gy IMRT alone in patients with newly-diagnosed prostate cancer with an intermediate-risk profile.
The trial contains two treatment arms:
Arm 1- Gene Therapy + IMRT Arm 2- IMRT
The study will be stratified by clinical site and pre-treatment risk factors (e.g., % positive biopsy cores, Gleason score.
- Gleason score 5/6 AND PSA <10 ng/mL; AND >=50% positive biopsy cores
- (Gleason score 5/6 and PSA 10-20 ng/mL) OR (Gleason score 7 and PSA 0 - 20 ng/mL); AND <50% positive biopsy cores
- Gleason score 5/6 and PSA 10-20 ng/mL) OR (Gleason score 7 and PSA 0-20 ng/mL) AND >=50% positive biopsy cores.
An interim safety analysis (Interim Analysis 1) will be conducted after the first 21 patients in the investigational therapy arm, and a total of 42 subjects in both arms, have completed the 90 day toxicity assessment following randomization (phase 2 component). If, at this point, there are no safety concerns as determined by the Data and Safety Monitoring Board (DSMB), the trial will continue as a phase 3 study with two additional interim analyses (Interim Analyses 2 \& 3). The primary analysis for treatment efficacy will be based on all randomized subjects.
Primary
To assess the relative efficacy of replication-competent adenovirus-mediated suicide gene therapy in combination with 80 Gy intensity modulated radiotherapy (IMRT) versus 80 Gy IMRT alone in patients with newly-diagnosed prostate cancer with an intermediate-risk profile. The primary endpoint is freedom from failure (FFF) (biochemical or clinical).
Secondary
To assess the difference between the two treatment arms for:
- Acute (<= 90 days) and long-term (> 90 days) toxicity.
- Prostate biopsy status (12 cores) at 2 years.
- Freedom from distant metastases.
- Disease-specific and overall survival.
- Quality of life.
Exploratory
To examine:
- Possible effect of gene therapy on PSA doubling time (PSADT) after PSA failure.
- Possible association between the primary and secondary outcomes and Ad5-yCD/mutTKSR39rep-ADP adenovirus persistence (as measured by adenoviral DNA in blood).
- Possible association between the primary and secondary outcomes and specific immunological endpoints including levels of circulating CD4+ and CD8+ T lymphocytes, T-cell proliferation response, cytotoxic T lymphocyte (CTL) response, and development of antibodies to prostate-specific antigens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ad5-yCD/mutTKSR39rep-ADP + IMRT | Experimental | Biological: Ad5-yCD/mutTKSR39rep-ADPGene Therapy + IMRT |
| IMRT Alone | Active comparator | Radiation: IMRTIMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Men with histologically-confirmed adenocarcinoma of the prostate within 180 days prior to registration. To be eligible, the subjects must have one of the following conditions:
- Negative lymph nodes as established by imaging, nodal sampling, or dissection within 90 days prior to registration.
- No evidence of metastatic disease as evaluated by bone scan and CT scan of the abdomen and pelvis within 90 days prior to registration
- Karnofsky performance status >=70
- Subjects must have adequate baseline organ function, as assessed by the following laboratory values, within 30 days before initiating the study
Key exclusion criteria (22 listed)
- Stage >= T3.
- Prostate specific antigen (PSA) > 20 ng/mL.
- Gleason score >= 8.
- Prostate volume >120cc.
- Pathologically positive lymph nodes or nodes > 1.5 cm on imaging. Note: nodes > 1.5 cm but biopsy negative are allowed.
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 |
|---|---|---|
| Ad5-yCD/mutTKSR39rep-ADPAd5-yCD/mutTKSR39rep-ADP (1 x 10^12 vp) on day 1 Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy | Biological | Ad5-yCD/mutTKSR39rep-ADP + IMRT |
| IMRT40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy | Radiation | IMRT Alone |
Primary outcome
Freedom From Biochemical/Clinical Failure (FFF)
Time frame: 5 years
Biochemical/Clinical Failure was defined as PSA nadir plus 2 ng/mL
5 secondary outcomes
Acute >= Grade 3 Treatment-related Toxicity
Time frame: 90 days
Positive Prostate Biopsy at 2 Years
Time frame: 2 years
Freedom From Distant Metastases
Time frame: 10 years
Disease-specific Survival
Time frame: 10 years
Decrease in Quality of Life
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12208748Freytag SO, Khil M, Stricker H, Peabody J, Menon M, DePeralta-Venturina M, Nafziger D, Pegg J, Paielli D, Brown S, Barton K, Lu M, Aguilar-Cordova E, Kim JH. Phase I study of replication-competent adenovirus-mediated double suicide gene therapy for the treatment of locally recurrent prostate cancer. Cancer Res. 2002 Sep 1;62(17):4968-76.
- Background: PubMed 17228316Freytag SO, Stricker H, Peabody J, Pegg J, Paielli D, Movsas B, Barton KN, Brown SL, Lu M, Kim JH. Five-year follow-up of trial of replication-competent adenovirus-mediated suicide gene therapy for treatment of prostate cancer. Mol Ther. 2007 Mar;15(3):636-42. doi: 10.1038/sj.mt.6300068. Epub 2007 Jan 16.
- Background: PubMed 14612551Freytag SO, Stricker H, Pegg J, Paielli D, Pradhan DG, Peabody J, DePeralta-Venturina M, Xia X, Brown S, Lu M, Kim JH. Phase I study of replication-competent adenovirus-mediated double-suicide gene therapy in combination with conventional-dose three-dimensional conformal radiation therapy for the treatment of newly diagnosed, intermediate- to high-risk prostate cancer. Cancer Res. 2003 Nov 1;63(21):7497-506.
- Background: PubMed 17375076Freytag SO, Movsas B, Aref I, Stricker H, Peabody J, Pegg J, Zhang Y, Barton KN, Brown SL, Lu M, Savera A, Kim JH. Phase I trial of replication-competent adenovirus-mediated suicide gene therapy combined with IMRT for prostate cancer. Mol Ther. 2007 May;15(5):1016-23. doi: 10.1038/mt.sj.6300120. Epub 2007 Mar 20.
- Results publication: PubMed 24837889Freytag SO, Stricker H, Lu M, Elshaikh M, Aref I, Pradhan D, Levin K, Kim JH, Peabody J, Siddiqui F, Barton K, Pegg J, Zhang Y, Cheng J, Oja-Tebbe N, Bourgeois R, Gupta N, Lane Z, Rodriguez R, DeWeese T, Movsas B. Prospective randomized phase 2 trial of intensity modulated radiation therapy with or without oncolytic adenovirus-mediated cytotoxic gene therapy in intermediate-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2014 Jun 1;89(2):268-76. doi: 10.1016/j.ijrobp.2014.02.034. Epub 2014 May 5.
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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.
Benjamin Movsas, M.D. principal investigator
Henry Ford Health System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ad5-yCD/mutTKSR39rep-ADP and IMRT in people with Prostate Cancer, run by Henry Ford Health System at 2 sites 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 16 inclusion and 22 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 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 17 Mar 2016). 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?
Freedom From Biochemical/Clinical Failure (FFF) (time frame: 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 NCT00583492, which also lists 5 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 17 Mar 2016.