Clinical trial NCT04032067: Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: Benign Prostatic Hyperplasia
GV1001
Lead sponsor: GemVax & Kael
Sponsor class: INDUSTRY
First posted: 2019-07-25
Enrollment: 423
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

1. A male at 50 years of age and older
2. Clinical signs and symptoms of benign prostatic hyperplasia

   1. A volume of prostate gland (TRUS) \> 30 cc
   2. Moderate to severe lower urinary tract symptoms with IPSS ≥ 13
   3. 5-15 mL/sec of maximum flow rate (Qmax) measured when urine volume was at least 125 mL
3. 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)
4. Residual urine volume ≤ 200 Ml
5. Consent not to participate in other clinical trials as a subject during this clinical trial period.
6. 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.

Exclusion Criteria:

1. Hypersensitivity reactions to ingredients of this drug.
2. 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.
3. Taking drugs of an unapproved study drug in the past or the study drug for this clinical trial
4. Diagnosis with prostate cancer in the past or at present
5. 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
6. Surgeries or radiation therapies for prostate gland, bladder or pelvis, or who had invasive treatments for benign prostatic hyperplasia
7. 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.)
8. Moderate to severe liver hypofunction and severe kidney hypofunction (less than 30 mL/min of creatinine clearance)
9. Any other subjects who are considered to be ineligible for this study by an investigator

\[Inclusion Criteria for Randomization\]

1. Clinical signs and symptoms of benign prostatic hyperplasia

   1. Volume of prostate gland (TRUS) \> 30 cc \*
   2. moderate to severe lower urinary tract symptoms with IPSS ≥ 13
   3. 5-15 mL/sec of maximum flow rate (Qmax) measured when urine volume was at least 125 mL
2. Residual urine volume ≤ 200 mL
3. 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.)

Primary outcomes:
measure: Change in International Prostate Symptom Score(IPSS)
timeFrame: Week 24
Secondary outcomes:
measure: Change in International Prostate Symptom Score(IPSS)
timeFrame: Weeks 4, 8, 12, 16 and 20
measure: Change in voiding score of International Prostate Symptom Score(IPSS)
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: Change in Prostatic Volume(PV)
timeFrame: Weeks 12 and 24
measure: Change in Maximum(peak) Urinary Flow Rate
timeFrame: Weeks 12 and 24
measure: Change in Prostate-specific Antigen (PSA)
timeFrame: Weeks 12 and 24
measure: Change in Residual Urine Volume
timeFrame: Weeks 12 and 24
measure: Change in Hormones (Testosterone, DHT)
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: Change in International Index of Erectile Function (IIEF)
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: rate of incidence of Acute urinary tract(AUR)
timeFrame: Every 2 weeks After screening visit up to 24 week
measure: Ratio of prostate surgery and minimally invasive (non-surgical) procedure
timeFrame: Every 2 weeks After screening visit up to 24 week
Other outcomes:
Locations:
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Gyeongju
country: Korea, Republic of
facility: Dongguk University Gyeongju Hospital
state: Gyeongsangbuk-do
city: Anyang
country: Korea, Republic of
facility: Hallym University Medical Center
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Changwon
country: Korea, Republic of
facility: Samsung Changwon Medical Center
city: Cheonan
country: Korea, Republic of
facility: Soonchunhyang University Hospital
city: Chungbuk
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Chungnam
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Ilsan
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Eulji General Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Department of Urology, Dongguk University Gyeongju Hospital
name: Kyung Seop Lee
role: STUDY_CHAIR
References: