Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH)

NCT04032067 | Completed Phase 3

• 1 other identifier: KG8/2019
• Study Type: interventional
• Target: 423
• Locations: 1 country
• Sites: 23

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.

Conditions

Benign Prostatic Hyperplasia (BPH)

Keywords

Benign Prostatic Hyperplasia; GV1001

Outcome Measures

Primary Outcomes (1)

• 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).

  Week 24

Secondary Outcomes (10)

• Change in International Prostate Symptom Score(IPSS)

  Weeks 4, 8, 12, 16 and 20

• Change in voiding score of International Prostate Symptom Score(IPSS)

  Weeks 4, 8, 12, 16, 20 and 24

• Change in Prostatic Volume(PV)

  Weeks 12 and 24

• Change in Maximum(peak) Urinary Flow Rate

  Weeks 12 and 24

• Change in Prostate-specific Antigen (PSA)

  Weeks 12 and 24

Study Arms (3)

Control Group

ACTIVE COMPARATOR

GV1001-Placebo ID injection administered every 2 weeks through Week 24 \+ Proscar PO administered once a day through Week 24

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

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

Drug: Proscar placebo

Interventions

GV1001 placebo DRUG

0.9 % Normal Saline

Also known as: Normal Saline

Control Group

Proscar placebo DRUG

PO

Also known as: Finasteride

Study Group 1; Study Group 2

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)
• 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.

You may not qualify if:

• 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
• 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
• 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
• 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.

Sponsors & Collaborators

• GemVax & Kael: lead

Study Sites (23)

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

Dongguk University Gyeongju Hospital

Gyeongju, Gyeongsangbuk-do, South Korea

Location

Hallym University Medical Center

Anyang, South Korea

Location

Inje University Busan Paik Hospital

Busan, South Korea

Location

Samsung Changwon Medical Center

Changwon, South Korea

Location

Soonchunhyang University Hospital

Cheonan, South Korea

Location

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Dongguk University Ilsan Hospital

Ilsan, South Korea

Location

Jeonbuk National University Hospital

Jeonju, South Korea

Location

Chungbuk National University Hospital

Jungbuk, South Korea

Location

Chonnam National University Hospital

Jungnam, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Chung-ang University Hospital

Seoul, South Korea

Location

Eulji General Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Saline Solution; Finasteride

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Study Officials

• Kyung Seop Lee

  Department of Urology, Dongguk University Gyeongju Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 25, 2019
• Study Start: October 30, 2019
• Primary Completion: March 17, 2022
• Study Completion: March 17, 2022
• Last Updated: August 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (23)