Benign Prostatic Hyperplasia (BPH)Phase 3NCT04032067
Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH)
A Phase 3 study of Benign Prostatic Hyperplasia (BPH), run by GemVax & Kael at 23 sites in South Korea.
Trial summary
The current study is being conducted by the Sponsor to evaluate the efficacy and safety of GV1001 (0.56 mg and 1.12 mg) administered as a treatment for Benign prostate hyperplasia(BPH). Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 423 participants
- Where
- 23 sitesSouth Korea
- Study dates
- 30 Oct 2019to 17 Mar 2022
- Phase
- Phase 3
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A male at 50 years of age and older
- Clinical signs and symptoms of benign prostatic hyperplasia
- A volume of prostate gland (TRUS) > 30 cc
- Moderate to severe lower urinary tract symptoms with IPSS ≥ 13
- 5-15 mL/sec of maximum flow rate (Qmax) measured when urine volume was at least 125 mL
- PSA level < 10 ng/mL (however, if 4 ng/mL < PSA < 10 ng/mL, a person with a biopsy result, confirming that he does not have prostate cancer)
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- Residual urine volume ≤ 200 Ml
- Consent not to participate in other clinical trials as a subject during this clinical trial period.
- Consent of patient and patient's partner a. Patient
- Consent to avoid pregnancy by using condoms for 90 days after the end of study participation period and treatment. (Not applied if the patient had vasectomy.) b. Patient's partner (Consent should be obtained before visit 4, when necessary.)
- Consent to avoid pregnancy by using contraceptive devices or oral contraceptives during the patient's participation in clinical trial and for 90 days after the end of treatment, except if the partner reaches menopause or is surgically sterilized.
Who cannot join
- Hypersensitivity reactions to ingredients of this drug.
- Taking drugs that affect the results of clinical trials. ex) 5-alpha reductase inhibitors, drugs similar to LHRH, alpha blockers, alpha-beta blockers, anticholinergics, antidiuretic hormones, diuretics, PDE-5 inhibitors, beta-3 adrenoceptor antagonists, steroids, immune suppressants, saw palmetto, etc.
- Taking drugs of an unapproved study drug in the past or the study drug for this clinical trial
- Diagnosis with prostate cancer in the past or at present
- Diagnosis by an investigator to have an influence to an evaluation on urine flow symptoms due to other previous or current diseases besides benign prostatic hyperplasia
- Surgeries or radiation therapies for prostate gland, bladder or pelvis, or who had invasive treatments for benign prostatic hyperplasia
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- Severe medical condition which may be cause problem to conduct the clinical trial (e.g., chronic heart failure (CHF), difficult-to-control diabetes (HbA1c > 7%), mental disorder, drug, or alcohol abuse, etc.)
- Moderate to severe liver hypofunction and severe kidney hypofunction (less than 30 mL/min of creatinine clearance)
- Any other subjects who are considered to be ineligible for this study by an investigator
- [Inclusion Criteria for Randomization]
- Clinical signs and symptoms of benign prostatic hyperplasia
- Volume of prostate gland (TRUS) > 30 cc *
- moderate to severe lower urinary tract symptoms with IPSS ≥ 13
- 5-15 mL/sec of maximum flow rate (Qmax) measured when urine volume was at least 125 mL
- Residual urine volume ≤ 200 mL
- Patient's partner (Consent should be obtained before visit 4, when necessary.) - Consent to avoid pregnancy by using contraceptive devices or oral contraceptives during the patient's participation in clinical trial and for 90 days after the end of treatment, except if the partner reaches menopause or is surgically sterilized.
- ( In case that additional TRUS examination has been performed after screening, a decision should be made based on the latest result.)
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
South Korea23 sites
Hallym University Medical Center
Anyang
Inje University Busan Paik Hospital
Busan
Samsung Changwon Medical Center
Changwon
Soonchunhyang University Hospital
Cheonan
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Medical Center
Daegu
Kyungpook National University Chilgok Hospital
Daegu
Yeungnam University Medical Center
Daegu
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do
Dongguk University Gyeongju Hospital
Gyeongju, Gyeongsangbuk-do
Dongguk University Ilsan Hospital
Ilsan
Jeonbuk National University Hospital
Jeonju
Chungbuk National University Hospital
Jungbuk
Chonnam National University Hospital
Jungnam
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
Asan Medical Center
Seoul
Chung-ang University Hospital
Seoul
Eulji General Hospital
Seoul
Korea University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Severance Hospital
Seoul
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul
Pusan National University Yangsan Hospital
Yangsan
About this study
Official title: A Randomized, Active-Controlled, Double-Blind, Parallel Design, Multi-Center, Phase III Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH)
The current study is being conducted by the Sponsor to evaluate the efficacy and safety of GV1001 (0.56 mg and 1.12 mg) administered as a treatment for Benign prostate hyperplasia(BPH). The investigational drug, GV1001, was first developed as a cancer vaccine for use as active immunotherapy of cancer forms expressing telomerase (eg, pancreatic cancer, prostate cancer, etc.). Subsequently, it was found that GV1001 showed efficacy in alleviating BPH symptoms during in vivo studies by reducing the size of the prostate gland. Based on the result, the effectiveness of GV1001 as a treatment for BPH has been assessed in experimental animals that are designed to develop BPH.
It is considered that GV1001 acts to alleviate BPH and the results obtained from previous phase II study indicate that GV1001 may provide potential beneficial effects in BPH patients.
So this study is to verify the efficacy and safety of GV1001 on BPH population, large-scale clinical study than phase II.
Read the detailed description
This was a multi-center, randomized, Double-blind, Active-controlled, parallel design, Phase 3 study in patients with BPH. The study consisted of a Screening period, a 4-weeks Run-in/Washout period, a 24-week Treatment period, an Evaluation and Close-out Visit at Week 24.
There are a total of 3 groups in this study, which contained 2 study groups (GV1001) and 1 placebo group (0.9% normal saline). Approximately 417 patients are planned to be randomly assigned into the study in a 1:1:1 ratio. All patients are randomized into 1 of 3 treatment groups to ensure completion of patients.
The Screening period have a time period of 4 weeks before the beginning of Run-in/Washout period. Eligible patients entered into a 4-week Run-in/Washout period and receive placebo treatment, which will be completed before randomization on Week 0. All randomized patients will receive the investigational drug or a placebo via intradermal injection 12 times with a 2-week interval at Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24. Efficacy evaluation will be conducted at Weeks 4, 8, 12, 16, 20 and 24, and safety evaluation will be conducted throughout the 24-weeks period.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- GV1001 placebo, Proscar placebo
- Keywords
- Benign Prostatic Hyperplasia, GV1001
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GV1001 placeboDrug
Also called Normal Saline
0.9 % Normal Saline
Proscar placeboDrug
Also called Finasteride
PO
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | GV1001-Placebo ID injection administered every 2 weeks through Week 24
+ Proscar PO administered once a day through Week 24 Receives: Drug: GV1001 placebo |
| Study Group 1 | Experimental | GV1001 0.56 mg ID injection administered every 2 weeks through Week 24
+ Proscar-placebo PO administered once a day through Week 24 Receives: Drug: Proscar placebo |
| Study Group 2 | Experimental | GV1001 1.12 mg ID injection administered every 2 weeks through Week 24
+ Proscar-placebo PO administered once a day through Week 24 Receives: Drug: Proscar placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Prostate Symptom Score(IPSS)
The amount of change from International Prostate Symptom Score(IPSS )compared to the baseline.
The measures of the 7 items evaluating symptoms is evaluated from 0 to 5 for each item, the total coverage range is from 0 (no symptoms) to 35 (most severe symptoms).
And the quality of life assessment is assessed from 0 (very satisfactory) to 6 (very unsatisfactory).
Measured: Week 24
Secondary outcomes (10)
Change in International Prostate Symptom Score(IPSS)
The amount of change from International Prostate Symptom Score(IPSS )compared to the baseline.
The measures of the 7 items evaluating symptoms is evaluated from 0 to 5 for each item, the total coverage range is from 0 (no symptoms) to 35 (most severe symptoms).
And the quality of life assessment is assessed from 0 (very satisfactory) to 6 (very unsatisfactory).
Measured: Weeks 4, 8, 12, 16 and 20
Change in voiding score of International Prostate Symptom Score(IPSS)
The amount of change from voiding score of IPSS compared to the baseline. The voiding score is measured as the sum of the evaluation scores of items 1, 3, 5 and 6 of the seven symptom scores of the IPSS.
Measured: Weeks 4, 8, 12, 16, 20 and 24
Change in Prostatic Volume(PV)
The amount of change from Prostatic Volume(PV) compared to the baseline.
Measured: Weeks 12 and 24
Change in Maximum(peak) Urinary Flow Rate
The amount of change from Maximum(peak) Urinary Flow Rate compared to the baseline
Measured: Weeks 12 and 24
Change in Prostate-specific Antigen (PSA)
The amount of change from Prostate-specific Antigen (PSA) compared to the baseline
Measured: Weeks 12 and 24
Change in Residual Urine Volume
The amount of change from Residual Urine Volume compared to the baseline
Measured: Weeks 12 and 24
Change in Hormones (Testosterone, DHT)
The amount of change from Hormones (Testosterone, DHT) compared to the baseline
Measured: Weeks 4, 8, 12, 16, 20 and 24
Change in International Index of Erectile Function (IIEF)
The amount of change from International Index of Erectile Function (IIEF) compared to the baseline
Measured: Weeks 4, 8, 12, 16, 20 and 24
rate of incidence of Acute urinary tract(AUR)
The rate of incidence of Acute urinary tract(AUR), meaning clinical progression of prostate hypertrophy
Measured: Every 2 weeks After screening visit up to 24 week
Ratio of prostate surgery and minimally invasive (non-surgical) procedure
The ratio of prostate surgery and minimally invasive (non-surgical) procedure, meaning clinical progression of prostate hypertrophy
Measured: Every 2 weeks After screening visit up to 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start30 Oct 2019
- Primary completion17 Mar 2022
- Study completion17 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- GemVax & Kael
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung Seop Lee, Study chair, Department of Urology, Dongguk University Gyeongju Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032067
- Sponsor's protocol ID
- KG8/2019
- Status last verified
- Feb 2022
- First submitted
- 19 Jul 2019
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Active-Controlled, Double-Blind, Parallel Design, Multi-Center, Phase III Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH)
- ClinicalTrials.gov ID
- NCT04032067
- Acronym / sponsor ID
- KG8/2019
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Keywords
- Benign Prostatic Hyperplasia, GV1001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- GemVax & KaelIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 25 Jul 2019 (actual)
- 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 current study is being conducted by the Sponsor to evaluate the efficacy and safety of GV1001 (0.56 mg and 1.12 mg) administered as a treatment for Benign prostate hyperplasia(BPH). The investigational drug, GV1001, was first developed as a cancer vaccine for use as active immunotherapy of cancer forms expressing telomerase (eg, pancreatic cancer, prostate cancer, etc.). Subsequently, it was found that GV1001 showed efficacy in alleviating BPH symptoms during in vivo studies by reducing the size of the prostate gland. Based on the result, the effectiveness of GV1001 as a treatment for BPH has been assessed in experimental animals that are designed to develop BPH.
It is considered that GV1001 acts to alleviate BPH and the results obtained from previous phase II study indicate that GV1001 may provide potential beneficial effects in BPH patients.
So this study is to verify the efficacy and safety of GV1001 on BPH population, large-scale clinical study than phase II.
Detailed description
This was a multi-center, randomized, Double-blind, Active-controlled, parallel design, Phase 3 study in patients with BPH. The study consisted of a Screening period, a 4-weeks Run-in/Washout period, a 24-week Treatment period, an Evaluation and Close-out Visit at Week 24.
There are a total of 3 groups in this study, which contained 2 study groups (GV1001) and 1 placebo group (0.9% normal saline). Approximately 417 patients are planned to be randomly assigned into the study in a 1:1:1 ratio. All patients are randomized into 1 of 3 treatment groups to ensure completion of patients.
The Screening period have a time period of 4 weeks before the beginning of Run-in/Washout period. Eligible patients entered into a 4-week Run-in/Washout period and receive placebo treatment, which will be completed before randomization on Week 0. All randomized patients will receive the investigational drug or a placebo via intradermal injection 12 times with a 2-week interval at Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24. Efficacy evaluation will be conducted at Weeks 4, 8, 12, 16, 20 and 24, and safety evaluation will be conducted throughout the 24-weeks period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: GV1001 placeboGV1001-Placebo ID injection administered every 2 weeks through Week 24 + Proscar PO administered once a day through Week 24 |
| Study Group 1 | Experimental | Drug: Proscar placeboGV1001 0.56 mg ID injection administered every 2 weeks through Week 24 + Proscar-placebo PO administered once a day through Week 24 |
| Study Group 2 | Experimental | Drug: Proscar placeboGV1001 1.12 mg ID injection administered every 2 weeks through Week 24 + Proscar-placebo PO administered once a day through Week 24 |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- A male at 50 years of age and older
- Clinical signs and symptoms of benign prostatic hyperplasia
- PSA level < 10 ng/mL (however, if 4 ng/mL < PSA < 10 ng/mL, a person with a biopsy result, confirming that he does not have prostate cancer)
- Residual urine volume ≤ 200 Ml
- Consent not to participate in other clinical trials as a subject during this clinical trial period.
Key exclusion criteria (17 listed)
- Hypersensitivity reactions to ingredients of this drug.
- Taking drugs that affect the results of clinical trials. ex) 5-alpha reductase inhibitors, drugs similar to LHRH, alpha blockers, alpha-beta blockers, anticholinergics, antidiuretic hormones, diuretics, PDE-5 inhibitors, beta-3 adrenoceptor antagonists, steroids, immune suppressants, saw palmetto, etc.
- Taking drugs of an unapproved study drug in the past or the study drug for this clinical trial
- Diagnosis with prostate cancer in the past or at present
- Diagnosis by an investigator to have an influence to an evaluation on urine flow symptoms due to other previous or current diseases besides benign prostatic hyperplasia
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 |
|---|---|---|
| GV1001 placeboAlso: Normal Saline0.9 % Normal Saline | Drug | Control Group |
| Proscar placeboAlso: FinasteridePO | Drug | Study Group 1, Study Group 2 |
Primary outcome
Change in International Prostate Symptom Score(IPSS)
Time frame: Week 24
The amount of change from International Prostate Symptom Score(IPSS )compared to the baseline. The measures of the 7 items evaluating symptoms is evaluated from 0 to 5 for each item, the total coverage range is from 0 (no symptoms) to 35 (most severe symptoms). And the quality of life assessment is assessed from 0 (very satisfactory) to 6 (very unsatisfactory).
10 secondary outcomes
Change in International Prostate Symptom Score(IPSS)
Time frame: Weeks 4, 8, 12, 16 and 20
Change in voiding score of International Prostate Symptom Score(IPSS)
Time frame: Weeks 4, 8, 12, 16, 20 and 24
Change in Prostatic Volume(PV)
Time frame: Weeks 12 and 24
Change in Maximum(peak) Urinary Flow Rate
Time frame: Weeks 12 and 24
Change in Prostate-specific Antigen (PSA)
Time frame: Weeks 12 and 24
Change in Residual Urine Volume
Time frame: Weeks 12 and 24
Change in Hormones (Testosterone, DHT)
Time frame: Weeks 4, 8, 12, 16, 20 and 24
Change in International Index of Erectile Function (IIEF)
Time frame: Weeks 4, 8, 12, 16, 20 and 24
rate of incidence of Acute urinary tract(AUR)
Time frame: Every 2 weeks After screening visit up to 24 week
Ratio of prostate surgery and minimally invasive (non-surgical) procedure
Time frame: Every 2 weeks After screening visit up to 24 week
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 25 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Kyung Seop Lee study chair
Department of Urology, Dongguk University Gyeongju Hospital
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Benign Prostatic Hyperplasia (BPH), run by GemVax & Kael at 23 sites in South Korea.
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 17 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 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in International Prostate Symptom Score(IPSS) (time frame: Week 24). 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 25 Aug 2022.