Localized Prostate CancerPhase 1/2NCT01931046
Use of Recombinant Adenovirus Therapy to Treat Localized Prostate Cancer
A Phase 1/2 study testing Ad5-SGE-REIC/Dkk3 in people with Localized Prostate Cancer, run by Momotaro-Gene Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of AD5-SGE-REIC/Dkk-3 in patients with localized prostate cancer. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Localized Prostate Cancer
- What is being tested?
- Ad5-SGE-REIC/Dkk3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2013to Mar 2020
- Phase
- Phase 1/2
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be included:
- Male aged between 50 and 80 years (inclusive) with histologically documented clinically localized, adenocarcinoma of the prostate.
- Subject with clinical stage T1 or T2 with Gleason score of 6 or 7 (3+4 or 4+3).
- At least one (1) MRI evaluable tumor with volume of 400 mm3 or greater.
- At least total of 10 mm of cancer tissue based on an MRI guided 12-core biopsy.
- Recent (≤ 6 months prior to study entry) negative bone scan and computerized tomography (CT) scan of abdomen/pelvis.
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- Life expectancy of at least 5 years.
- Subjects should have adequate bone marrow function defined as an absolute peripheral granulocyte count ≥ 1,500 and platelet count of ≥ 100,000, adequate hepatic function with a bilirubin ≤ 1.5 mg/dl and serum glutamic-pyruvic transaminase (SGPT) < 4x the upper limits of normal, adequate renal function defined as serum creatinine ≤ 2.0 mg/dl
- Subjects must have a coagulation profile (prothrombin time [PT], partial thromboplastin time [PTT]) not more than 2-times the upper limit of normal and no history of substantial non-iatrogenic bleeding diatheses. Use of anticoagulants within 5-days of the Ad5-SGE-REIC/Dkk-3 injections is limited to local use only (for control of central line patency).
- Subject is willing to refrain from sexual activity or agrees to use a barrier contraceptive device (e.g. condom) for 8-weeks after treatment with Ad5-SGE-REIC/Dkk-3.
- Subjects must sign an informed consent indicating that they are aware of the investigational nature of the study.
Who cannot join
- Subjects meeting any of the following criteria will be excluded:
- Prior primary radiation treatment to the prostate.
- Severe bladder outlet obstructive disorder (AUA >25) or urinary track retention.
- Chemotherapy, immunotherapy or other investigational study drug within the past 4 weeks.
- Unable to tolerate TRUS.
- Subjects with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorders, that in the opinion of the investigator put the subject at significant risk, are not eligible.
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- Subjects who are HIV positive or have active hepatitis B or C infections are not eligible.
- Subjects with a clinical history of primary or secondary immunodeficiency, autoimmune disease or subjects taking immunosuppressive drugs such as corticosteroids continuously for > 4 months [> 5 mg hydrocortisone/day] are ineligible.
- As a result of medical review, physical examination, the Principal Investigator (or medically qualified nominee) considers the subject unfit for the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
The Methodist Hospital Research Institute
Houston, Texas, 77030
UCSD Moores Cancer Center
San Diego, California, 92093
About this study
Official title: A Phase 1 / 2a Study of In-situ REIC/Dkk-3 Therapy in Patients With Localized Prostate Cancer (MTG-REIC-PC003)
The purpose of this study is to evaluate the safety and effectiveness of AD5-SGE-REIC/Dkk-3 in patients with localized prostate cancer.
Read the detailed description
This is a phase 1/2a clinical trial in subjects who are diagnosed with prostate cancer to evaluate the effectiveness of Ad5-SGE-REIC/Dkk-3 in the treatment of localized prostate cancer.
Subjects enrolled will be diagnosed with localized prostate cancer (clinical stage T1/T2) having a Gleason score of 6 to 7 (3+4 or 4+3). Subjects will receive up to four (4) transrectal ultrasound (TRUS)-guided IT treatments with Ad5-SGE-REIC/Dkk-3 into the prostate approximately 6-weeks apart. Each treatment cycle will be performed using a minimum of three track injections through the prostrate using a total of 3 mL volume. Approximately 2 mL of the total volume will be injected into the most dense areas of cancer based on biopsy and MRI mapping (fusion biopsy) and 1 mL total volume will be injected into the opposite lobe of the prostate or other areas to ensure complete saturation of the prostate over multiple injections.
Subjects who, in the opinion of the investigator, are progressing at any time after the second injection of Ad5-SGE-REIC/Dkk-3 may be discontinued and will be treated according to standard medical practice.
- Conditions
- Localized Prostate Cancer
- Being tested
- Ad5-SGE-REIC/Dkk3
- Keywords
- prostate cancer, adenocarcinoma of the prostate
- 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-SGE-REIC/Dkk3Drug
Ad5-SGE-REIC/Dkk-3, was designed to increase intracellular production REIC protein. The adenovirus vector is a transport mechanism to infuse the REIC protein into the cell providing a temporary transfusion of protein that induces apoptosis in target cancer cells, but does not appear to have a significant effect on normal tissues.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Treatment at one of three dose levels of Ad5-SGE-REIC/Dkk-3 in a sequential dose-escalating design with 4 cycles of therapy at each dose level permitted. Receives: Drug: Ad5-SGE-REIC/Dkk3 |
| Part 2 | Experimental | Treatment with Ad5-SGE-REIC/Dkk-3 every 6-weeks for up to 4 cycles of therapy and may continue therapy if they have stable disease or are responding. Receives: Drug: Ad5-SGE-REIC/Dkk3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
To define the Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD) for intratumoral injection (IT) of Ad5-SGE-REIC/Dkk-3 viral vector.
Measured: Up to 24 weeks
Secondary outcomes (2)
Effectiveness of Ad5-SGE-REIC/Dkk-3
To assess the effectiveness of Ad5-SGE-REIC/Dkk-3 in the treatment of prostate cancer as evaluated by biomarkers, transrectal ultrasound (TRUS), biopsy and MRI.
Measured: Up to 78 weeks
Rate and intensity of adverse reactions after treatment with Ad5-SGE-REIC/Dkk-3
To assess the rate of adverse events and grade of adverse events after in-situ therapy with Ad5-SGE-REIC/Dkk-3 protein in prostate cancer subjects.
Measured: Up to 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startOct 2013
- Primary completion6 Jul 2018
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momotaro-Gene Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Pacific Link Consulting Co
- Responsible party
- Sponsor
- Investigators
- Christopher J Kane, MD, Principal investigator, University of California, San DiegoBrian J Miles, MD, FACS, Principal investigator, Baylor College of Medicine and Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931046
- Sponsor's protocol ID
- MTG-REIC-PC003
- Status last verified
- Sep 2020
- First submitted
- 21 Aug 2013
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 / 2a Study of In-situ REIC/Dkk-3 Therapy in Patients With Localized Prostate Cancer (MTG-REIC-PC003)
- ClinicalTrials.gov ID
- NCT01931046
- Acronym / sponsor ID
- MTG-REIC-PC003
- Conditions
- Localized Prostate Cancer
- Keywords
- prostate cancer, adenocarcinoma of the prostate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Momotaro-Gene Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Pacific Link Consulting Co
- Study start
- Oct 2013
- Primary completion
- 6 Jul 2018 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 29 Aug 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.
The purpose of this study is to evaluate the safety and effectiveness of AD5-SGE-REIC/Dkk-3 in patients with localized prostate cancer.
Detailed description
This is a phase 1/2a clinical trial in subjects who are diagnosed with prostate cancer to evaluate the effectiveness of Ad5-SGE-REIC/Dkk-3 in the treatment of localized prostate cancer.
Subjects enrolled will be diagnosed with localized prostate cancer (clinical stage T1/T2) having a Gleason score of 6 to 7 (3+4 or 4+3). Subjects will receive up to four (4) transrectal ultrasound (TRUS)-guided IT treatments with Ad5-SGE-REIC/Dkk-3 into the prostate approximately 6-weeks apart. Each treatment cycle will be performed using a minimum of three track injections through the prostrate using a total of 3 mL volume. Approximately 2 mL of the total volume will be injected into the most dense areas of cancer based on biopsy and MRI mapping (fusion biopsy) and 1 mL total volume will be injected into the opposite lobe of the prostate or other areas to ensure complete saturation of the prostate over multiple injections.
Subjects who, in the opinion of the investigator, are progressing at any time after the second injection of Ad5-SGE-REIC/Dkk-3 may be discontinued and will be treated according to standard medical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: Ad5-SGE-REIC/Dkk3Treatment at one of three dose levels of Ad5-SGE-REIC/Dkk-3 in a sequential dose-escalating design with 4 cycles of therapy at each dose level permitted. |
| Part 2 | Experimental | Drug: Ad5-SGE-REIC/Dkk3Treatment with Ad5-SGE-REIC/Dkk-3 every 6-weeks for up to 4 cycles of therapy and may continue therapy if they have stable disease or are responding. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male aged between 50 and 80 years (inclusive) with histologically documented clinically localized, adenocarcinoma of the prostate.
- Subject with clinical stage T1 or T2 with Gleason score of 6 or 7 (3+4 or 4+3).
- At least one (1) MRI evaluable tumor with volume of 400 mm3 or greater.
- At least total of 10 mm of cancer tissue based on an MRI guided 12-core biopsy.
- Recent (≤ 6 months prior to study entry) negative bone scan and computerized tomography (CT) scan of abdomen/pelvis.
Key exclusion criteria (9 listed)
- Prior primary radiation treatment to the prostate.
- Severe bladder outlet obstructive disorder (AUA >25) or urinary track retention.
- Chemotherapy, immunotherapy or other investigational study drug within the past 4 weeks.
- Unable to tolerate TRUS.
- Subjects with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorders, that in the opinion of the investigator put the subject at significant risk, are not eligible.
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-SGE-REIC/Dkk3Ad5-SGE-REIC/Dkk-3, was designed to increase intracellular production REIC protein. The adenovirus vector is a transport mechanism to infuse the REIC protein into the cell providing a temporary transfusion of protein that induces apoptosis in target cancer cells, but does not appear to have a significant effect on normal tissues. | Drug | Part 1, Part 2 |
Primary outcome
Maximum Tolerated Dose
Time frame: Up to 24 weeks
To define the Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD) for intratumoral injection (IT) of Ad5-SGE-REIC/Dkk-3 viral vector.
2 secondary outcomes
Effectiveness of Ad5-SGE-REIC/Dkk-3
Time frame: Up to 78 weeks
Rate and intensity of adverse reactions after treatment with Ad5-SGE-REIC/Dkk-3
Time frame: Up to 54 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
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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.
Christopher J Kane, MD principal investigator
University of California, San Diego
Brian J Miles, MD, FACS principal investigator
Baylor College of Medicine and Methodist Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ad5-SGE-REIC/Dkk3 in people with Localized Prostate Cancer, run by Momotaro-Gene Inc. at 3 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 11 inclusion and 9 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 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Tolerated Dose (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2020.