Prostatic AdenomaPhase 2TEAChNCT04693507
Teverelix Evaluated in Advanced Prostate Cancer
A Phase 2 study testing teverelix TFA 120 mg and teverelix TFA 180 mg in people with Prostatic Adenoma, run by Antev Ltd. at 4 sites in Lithuania.
Trial summary
The purpose of this study is to assess the safety and efficacy of teverelix TFA in the treatment of advanced prostate cancer Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostatic Adenoma
- What is being tested?
- teverelix TFA 120 mg and teverelix TFA 180 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesLithuania
- Study dates
- 4 Mar 2021to 6 Feb 2023
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is male, aged ≤80 years (≥18 years) at the beginning of the treatment period (Day 0)
- Has histologically proven advanced adenocarcinoma of the prostate (metastatic or non metastatic hormone-sensitive non curative), suitable for ADT
- Is treatment naïve for any of the following: a. GnRH analogues b. Androgen receptor antagonists, or c. Androgen synthesis inhibitors (e.g. abiraterone)
- Agrees to practice contraception during the entire study treatment period and for 3 months after the last dose of IMP is administered: a. Either by using double barrier contraception, b. or, is truly sexually abstinent, when this is in line with the preferred and usual lifestyle of the participant
- Has provided written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed a part of his normal medical care
Who cannot join
- Has abnormal screening and/or baseline laboratory values that suggest a clinically significant underlying disease, or the following laboratory values: a. Liver function test (aspartate aminotransferase [ASAT/SGOT], alanine aminotransferase [ALAT/SGPT]), or total bilirubin exceeding twice the upper limit of the normal (ULN) range b. Creatinine twice the ULN range c. Uncontrolled diabetes (HbA1c >7.5%) or previously undiagnosed diabetes mellitus with HbA1c >6.5%
- Has any contraindication to the use of teverelix TFA
- Has life expectancy of less than 1 year
- Has T levels <2.0 ng/mL at screening
- Has a medical history of bilateral orchidectomy
- Using any of the following prohibited treatments: a. Within 25 weeks prior to screening: dutasteride b. Within 12 weeks prior to screening: finasteride c. Current use of any of the following: i. Anti-androgen therapy, including T replacement therapy and 5α-reductase inhibitor treatment etc. ii. GnRH analogues, androgen receptor antagonists iii. Androgen synthesis inhibitors (e.g. abiraterone) iv. Any other medication or herbal product that may affect hormone levels and might, therefore, confound interpretation of the study results (e.g. St. John's wort)
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- Has neurological disease, psychiatric disease, drug or alcohol abuse, which could interfere with the participant's proper compliance
- Has a history of myocardial infarction, unstable symptomatic ischaemic heart disease, any ongoing cardiac arrhythmias of grade >2 (chronic stable atrial fibrillation on stable anticoagulant therapy is allowed), thromboembolic events (e.g. deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other significant cardiac condition (e.g. pericardial effusion, restrictive cardiomyopathy) within 6 months before screening
- Has congenital long QT syndrome or ECG abnormalities at screening of: a. Q-wave infarction, unless identified ≥6 months before screening b. Fridericia corrected QT interval (QTcF interval) >480 msec. If QTcF is prolonged in a participant with a pacemaker, the participant may be enrolled in the study upon discussion with the project clinician c. If the QTcF interval is 450-480 msec, inclusive, in a participant with current use of medications with known effects on QT interval, the participant may be enrolled in the study following discussion with the Medical Lead
- Has known or suspected severe renal impairment
- Has a medical history of diagnosis of, or treatment for, another malignancy within 2 years before the first dose of IMP, or previous diagnosis of another malignancy with evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
- Is currently using Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic medications
- Has uncontrolled hypertension despite appropriate medical therapy (sitting BP of >180 millimetres of mercury [mmHg] systolic and >95 mmHg diastolic at 2 separate measurements taken no more than 60 minutes apart during the screening visit). Participants with isolated systolic BP measurements >180 mmHg may be rescreened. Participants with isolated systolic BP measurements 141 to 180 mmHg or isolated diastolic BP measurements ≥95 mmHg, although eligible, should be referred for further management of hypertension if indicated
- Has known, previously diagnosed human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, life-threatening illness unrelated to prostate cancer, or any serious medical condition that could, in the investigator's opinion, potentially interfere with participation in this study. Specific screening for chronic viral illness is at the discretion of the site and/or local Institutional Review Board (IRB)
- Has been exposed to another investigational drug within the 3 months prior to screening
- Has anticipated non-availability for study visits/procedures
- Plans to undergo surgery during the study period
- Known presence of hepatic metastases
Trial locations and contacts
4 sites in 1 country.
Lithuania4 sites
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, LT-50161
Klaipeda University Hospital
Klaipėda, LT-92288
National Cancer Institute
Vilnius, LT-08660
Vilnius University Hospital Santaros Clinic
Vilnius, LT-08661
About this study
Official title: An Adaptive Phase 2, Open-Label, Multicentre Study Investigating the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Teverelix Trifluoroacetate, a GnRH Antagonist, in Participants With Advanced Prostate Cancer
The purpose of this study is to assess the safety and efficacy of teverelix TFA in the treatment of advanced prostate cancer
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo an up to 7 day screening period to determine eligibility for study entry. On Day 0, patients who meet the eligibility requirements will be enrolled in an open-label manner and will receive a loading dose of teverelix TFA (one subcutaneous (SC) injection in the abdomen and one intramuscular (IM) injection in the buttock). Patients will then receive maintenance doses of teverelix TFA (one SC injection in the abdomen) at 4- or 6-weekly intervals up to week 24. The patients will return for a final assessment 4 weeks after their last maintenance dose injection.
The initial dosing regimen to be tested (Group 1) is:
Loading Dose = 120 mg teverelix TFA SC + 120 mg teverelix TFA IM Maintenance Dose = 120 mg teverelix TFA SC every 6 weeks
If this dosing regimen is unsuccessful (more than 2 (of 20) patients fail treatment) then recruitment to Group 1 will end and enrollment in Group 2 will open.
The dosing regimen that may be tested (Group 2) is:
Loading Dose = 180 mg teverelix TFA SC + 180 mg teverelix TFA IM Maintenance Dose = 180 mg teverelix TFA SC every 6 weeks
If this dosing regimen is unsuccessful (more than 6 (of 60) patients fail treatment) then recruitment to Group 2 will end and the study will be terminated.
- Conditions
- Prostatic Adenoma
- Being tested
- teverelix TFA 120 mg, teverelix TFA 180 mg
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teverelix TFA 120 mgDrug
Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24
teverelix TFA 180 mgDrug
Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
| Study group | Role | What they receive |
|---|---|---|
| Teverelix TFA 120 mg 6-weekly | Experimental | Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 Receives: Drug: teverelix TFA 120 mg |
| Teverelix TFA 180 mg 6-weekly | Experimental | Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 Receives: Drug: teverelix TFA 180 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testosterone (T) Levels (Castrate) at Week 4
Proportion of participants achieving castration level with serum T <0.5 ng/mL at Day 28.
Measured: 4 weeks
Secondary outcomes (34)
Testosterone (T) Levels (0.2 ng/mL) at Week 4
Proportion of participants achieving castration level with serum T <0.2 ng/mL at Day 28
Measured: 4 weeks
Testosterone (T) Levels (Castrate) at Week 6
Proportion of participants achieving castration level with serum T <0.5 ng/mL at Day 42
Measured: 6 weeks
Testosterone (T) Levels (0.2 ng/mL) at Week 6
Proportion of participants achieving profound castration level (0.2 ng/mL) with serum T <0.5 ng/mL at Day 42
Measured: 6 weeks
Testosterone Levels (Castrate) at Week 24
Proportion of participants achieving a T castration rate over 168 days of treatment period
Measured: 24 weeks
Testosterone Levels (0.2 ng/mL) at Week 24
Proportion of participants achieving profound castration rate (<0.2 ng/mL) over 168 days of treatment period
Measured: 24 weeks
Time to Achieve Castrate Levels of Testosterone (T)
Mean time to T levels falling below castration level (<0.5 ng/mL) for the first time
Measured: 4 weeks
Time to Escape Castrate Levels of Testosterone (T)
Mean time to (first) overstep of T castration level after achieving castration
Measured: Approximately 30 weeks
Luteinizing Hormone (LH) Levels (Castrate) at Week 4
Proportion of participants achieving castration level for LH (LH <1.1 U/L) at Day 28
Measured: 4 weeks
Luteinizing Hormone (LH) Levels (Castrate) at Week 24
Proportion of participants with effective LH castration rate over 168 days of treatment period
Measured: 24 weeks
Time to Achieve Castrate Levels of Luteinizing Hormone (LH)
Mean time to LH levels falling below castration level (LH <1.1 U/L) for the first time
Measured: 4 weeks
Time to Escape Castrate Levels of Luteinizing Hormone (LH)
Mean time to (first) overstep of LH castration level after achieving castration
Measured: 24 weeks
Change in Testosterone Levels Over Time (Change From Baseline at Day 168)
The change in testosterone levels over time (Change from Baseline at Day 168)
Measured: 24 weeks
Change in LH Levels Over Time
The change in LH levels over time
Measured: 24 weeks
Change in FSH Levels Over Time
The change in FSH levels over time
Measured: 24 weeks
Area Under the Concentration Time-curve From Time Zero up to the Last Quantifiable Concentration at Time Point t (AUC0-t)
Area under the concentration time-curve from time zero up to the last quantifiable concentration at time point t (Ct), calculated using the linear up/log down trapezoidal rule.
Measured: 24 weeks
Area Under the Concentration Time-curve From Time Zero up to the Concentration at Time Point t1 After Which the Concentrations Start to Rise Again Towards a Second Peak (AUC0-t1)
Area under the concentration time-curve from time zero up to the concentration at time point t1 after which the concentrations start to rise again towards a second peak, calculated using the linear up/log down trapezoidal rule. t1 will be determined after review of the concentration-time profiles (immediate release component of total observed AUC).
Measured: 24 weeks
Maximum Observed Plasma Teverelix Concentration After Administration (Cmax)
The maximum observed plasma teverelix concentration after administration (Cmax)
Measured: 24 weeks
Maximum Observed Concentration After Administration From Zero up to Time Point t1 (Cmax,0-t1)
The maximum observed concentration after administration from zero up to time point t1 (Cmax,0-t1)
Measured: 24 weeks
Maximum Observed Concentration After Administration From Time Point t1 up to Time Point t (Cmax,t1-t)
The maximum observed concentration after administration from time point t1 up to time point t (Cmax,t1-t)
Measured: 24 weeks
Time to Reach Cmax After Dosing (Tmax)
The time to reach Cmax after dosing (tmax)
Measured: 24 weeks
Time to Reach Cmax,0-t1 After Dosing (Tmax,0-t1)
The time to reach Cmax,0-t1 after dosing (tmax,0-t1)
Measured: 24 weeks
Time to Reach Cmax,t1-t After Dosing (Tmax,t1-t)
The time to reach Cmax,t1-t after dosing (tmax,t1-t)
Measured: 24 weeks
Apparent Terminal Elimination Rate Constant (Lambda-z)
The apparent terminal elimination rate constant (lambda-z)
Measured: 24 weeks
Apparent Terminal Plasma Half-life (t½)
Apparent terminal plasma half-life, calculated as: ln 2 / lambda-z
Measured: 24 weeks
Area Under the Concentration Time-curve From Time Zero up to Infinity (∞)(AUC0-∞)
Area under the concentration time-curve from time zero up to infinity (∞),calculated using the linear up/log down trapezoidal rule.
Measured: 24 weeks
Prostate Specific Antigen (PSA) Reduction (≥50 Percent)
Number of participants with a PSA response of ≥50 percent reduction at the Day 168 visit
Measured: 24 weeks
PSA Response Rate at Day 28
PSA response is defined as >50% decline in PSA at Day 28. PSA response rate is the number of subjects with a PSA response.
Measured: 24 weeks
PSA Response ≥50% at Day 168
The number of subjects with a PSA response ≥50% at Day 168
Measured: 24 weeks
Luteinizing Hormone (LH) Mean % Reduction at Day 168
Luteinizing Hormone (LH) - the mean % reduction at Day 168
Measured: 24 weeks
Testosterone (T) Mean % Reduction at Day 168
Testosterone (T) - the mean % reduction at Day 168
Measured: 24 weeks
Follicle Stimulating Hormone (FSH) Mean % Reduction at Day 168
Follicle Stimulating Hormone (FSH) - the mean % reduction at Day 168
Measured: 24 weeks
Treatment-emergent Adverse Events (AEs)
Number of participants with treatment-emergent AEs
Measured: 24 weeks
ECG QTcF Interval Prolongation >450 Msec at Day 28
ECG QTcF Interval prolongation >450 msec at Day 28 study visit
Measured: 24 weeks
Injection Site Reactions (ISRs)
Number of participants with ISRs at each visit during the 168 days treatment period
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start4 Mar 2021
- Primary completion5 Dec 2022
- Study completion6 Feb 2023
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 (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic AdenomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Adaptive design - enrollment will open in Group 1 (6-weekly dosing regimen). Only if Group 1 dosing regimen is unsuccessful will enrollment open in Group 2 (4-weekly dosing regimen)
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antev Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Albertas Ulys, MD, Principal investigator, National Cancer Institute, Vilnius, Lithuania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693507
- Sponsor's protocol ID
- ANT-1111-02
- Acronym
- TEACh
- Status last verified
- Jan 2024
- First submitted
- 29 Dec 2020
- Last updated
- 23 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ulys A, Jankevicus F, Jievaltas M, Venckus R, Auskalnis S, Kardelis Z, Barisiene M, MacLean CM, van Os S, Larsen F. Efficacy, tolerability, and safety of teverelix DP in patients with advanced prostate cancer: A multicenter, open-label, phase 2 trial. Prostate. 2024 May;84(6):584-598. doi: 10.1002/pros.24674. Epub 2024 Feb 4.
PubMed 38311868
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Phase 2, Open-Label, Multicentre Study Investigating the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Teverelix Trifluoroacetate, a GnRH Antagonist, in Participants With Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT04693507
- Acronym / sponsor ID
- TEACh / ANT-1111-02
- Conditions
- Prostatic Adenoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Antev Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 6 Feb 2023 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Posted 23 Jul 2024
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 assess the safety and efficacy of teverelix TFA in the treatment of advanced prostate cancer
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo an up to 7 day screening period to determine eligibility for study entry. On Day 0, patients who meet the eligibility requirements will be enrolled in an open-label manner and will receive a loading dose of teverelix TFA (one subcutaneous (SC) injection in the abdomen and one intramuscular (IM) injection in the buttock). Patients will then receive maintenance doses of teverelix TFA (one SC injection in the abdomen) at 4- or 6-weekly intervals up to week 24. The patients will return for a final assessment 4 weeks after their last maintenance dose injection.
The initial dosing regimen to be tested (Group 1) is:
Loading Dose = 120 mg teverelix TFA SC + 120 mg teverelix TFA IM Maintenance Dose = 120 mg teverelix TFA SC every 6 weeks
If this dosing regimen is unsuccessful (more than 2 (of 20) patients fail treatment) then recruitment to Group 1 will end and enrollment in Group 2 will open.
The dosing regimen that may be tested (Group 2) is:
Loading Dose = 180 mg teverelix TFA SC + 180 mg teverelix TFA IM Maintenance Dose = 180 mg teverelix TFA SC every 6 weeks
If this dosing regimen is unsuccessful (more than 6 (of 60) patients fail treatment) then recruitment to Group 2 will end and the study will be terminated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Adaptive design - enrollment will open in Group 1 (6-weekly dosing regimen). Only if Group 1 dosing regimen is unsuccessful will enrollment open in Group 2 (4-weekly dosing regimen)
| Arm | Type | Receives |
|---|---|---|
| Teverelix TFA 120 mg 6-weekly | Experimental | Drug: teverelix TFA 120 mgParticipants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 |
| Teverelix TFA 180 mg 6-weekly | Experimental | Drug: teverelix TFA 180 mgParticipants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Is male, aged ≤80 years (≥18 years) at the beginning of the treatment period (Day 0)
- Has histologically proven advanced adenocarcinoma of the prostate (metastatic or non metastatic hormone-sensitive non curative), suitable for ADT
- Is treatment naïve for any of the following: a. GnRH analogues b. Androgen receptor antagonists, or c. Androgen synthesis inhibitors (e.g. abiraterone)
- Agrees to practice contraception during the entire study treatment period and for 3 months after the last dose of IMP is administered: a. Either by using double barrier contraception, b. or, is truly sexually abstinent, when this is in line with the preferred and usual lifestyle of the participant
- Has provided written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed a part of his normal medical care
Key exclusion criteria (18 listed)
- Has abnormal screening and/or baseline laboratory values that suggest a clinically significant underlying disease, or the following laboratory values: a. Liver function test (aspartate aminotransferase [ASAT/SGOT], alanine aminotransferase [ALAT/SGPT]), or total bilirubin exceeding twice the upper limit of the normal (ULN) range b. Creatinine twice the ULN range c. Uncontrolled diabetes (HbA1c >7.5%) or previously undiagnosed diabetes mellitus with HbA1c >6.5%
- Has any contraindication to the use of teverelix TFA
- Has life expectancy of less than 1 year
- Has T levels <2.0 ng/mL at screening
- Has a medical history of bilateral orchidectomy
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 |
|---|---|---|
| teverelix TFA 120 mgTeverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24 | Drug | Teverelix TFA 120 mg 6-weekly |
| teverelix TFA 180 mgTeverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24 | Drug | Teverelix TFA 180 mg 6-weekly |
Primary outcome
Testosterone (T) Levels (Castrate) at Week 4
Time frame: 4 weeks
Proportion of participants achieving castration level with serum T <0.5 ng/mL at Day 28.
34 secondary outcomes
Testosterone (T) Levels (0.2 ng/mL) at Week 4
Time frame: 4 weeks
Testosterone (T) Levels (Castrate) at Week 6
Time frame: 6 weeks
Testosterone (T) Levels (0.2 ng/mL) at Week 6
Time frame: 6 weeks
Testosterone Levels (Castrate) at Week 24
Time frame: 24 weeks
Testosterone Levels (0.2 ng/mL) at Week 24
Time frame: 24 weeks
Time to Achieve Castrate Levels of Testosterone (T)
Time frame: 4 weeks
Time to Escape Castrate Levels of Testosterone (T)
Time frame: Approximately 30 weeks
Luteinizing Hormone (LH) Levels (Castrate) at Week 4
Time frame: 4 weeks
Luteinizing Hormone (LH) Levels (Castrate) at Week 24
Time frame: 24 weeks
Time to Achieve Castrate Levels of Luteinizing Hormone (LH)
Time frame: 4 weeks
Time to Escape Castrate Levels of Luteinizing Hormone (LH)
Time frame: 24 weeks
Change in Testosterone Levels Over Time (Change From Baseline at Day 168)
Time frame: 24 weeks
Change in LH Levels Over Time
Time frame: 24 weeks
Change in FSH Levels Over Time
Time frame: 24 weeks
Area Under the Concentration Time-curve From Time Zero up to the Last Quantifiable Concentration at Time Point t (AUC0-t)
Time frame: 24 weeks
Area Under the Concentration Time-curve From Time Zero up to the Concentration at Time Point t1 After Which the Concentrations Start to Rise Again Towards a Second Peak (AUC0-t1)
Time frame: 24 weeks
Maximum Observed Plasma Teverelix Concentration After Administration (Cmax)
Time frame: 24 weeks
Maximum Observed Concentration After Administration From Zero up to Time Point t1 (Cmax,0-t1)
Time frame: 24 weeks
Maximum Observed Concentration After Administration From Time Point t1 up to Time Point t (Cmax,t1-t)
Time frame: 24 weeks
Time to Reach Cmax After Dosing (Tmax)
Time frame: 24 weeks
Time to Reach Cmax,0-t1 After Dosing (Tmax,0-t1)
Time frame: 24 weeks
Time to Reach Cmax,t1-t After Dosing (Tmax,t1-t)
Time frame: 24 weeks
Apparent Terminal Elimination Rate Constant (Lambda-z)
Time frame: 24 weeks
Apparent Terminal Plasma Half-life (t½)
Time frame: 24 weeks
Area Under the Concentration Time-curve From Time Zero up to Infinity (∞)(AUC0-∞)
Time frame: 24 weeks
Prostate Specific Antigen (PSA) Reduction (≥50 Percent)
Time frame: 24 weeks
PSA Response Rate at Day 28
Time frame: 24 weeks
PSA Response ≥50% at Day 168
Time frame: 24 weeks
Luteinizing Hormone (LH) Mean % Reduction at Day 168
Time frame: 24 weeks
Testosterone (T) Mean % Reduction at Day 168
Time frame: 24 weeks
Follicle Stimulating Hormone (FSH) Mean % Reduction at Day 168
Time frame: 24 weeks
Treatment-emergent Adverse Events (AEs)
Time frame: 24 weeks
ECG QTcF Interval Prolongation >450 Msec at Day 28
Time frame: 24 weeks
Injection Site Reactions (ISRs)
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38311868Ulys A, Jankevicus F, Jievaltas M, Venckus R, Auskalnis S, Kardelis Z, Barisiene M, MacLean CM, van Os S, Larsen F. Efficacy, tolerability, and safety of teverelix DP in patients with advanced prostate cancer: A multicenter, open-label, phase 2 trial. Prostate. 2024 May;84(6):584-598. doi: 10.1002/pros.24674. Epub 2024 Feb 4.
- 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.
Albertas Ulys, MD principal investigator
National Cancer Institute, Vilnius, Lithuania
4 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 teverelix TFA 120 mg and teverelix TFA 180 mg in people with Prostatic Adenoma, run by Antev Ltd. at 4 sites in Lithuania.
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 5 inclusion and 18 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 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Lithuania. 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 23 Jul 2024). 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?
Testosterone (T) Levels (Castrate) at Week 4 (time frame: 4 weeks). 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 NCT04693507, which also lists 1 linked publication.
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 23 Jul 2024.