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CompletedNCT04693507TEAChUpdated Jul 23, 2024Results posted

Teverelix Evaluated in Advanced Prostate Cancer

A Phase 2 interventional study of teverelix TFA 120 mg and teverelix TFA 180 mg in Prostatic Adenoma, sponsored by Antev Ltd.. Completed at 4 sites in Lithuania. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-23.

Sponsored by Antev Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Prostatic Adenoma

Browse trials for

03

In context

Prostatic Hyperplasia

803 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 50 is below the median of 96 across 610 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Antev Ltd. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Teverelix TFA 120 mg 6-weekly

    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

    Drug: teverelix TFA 120 mg

  • Experimental
    Teverelix TFA 180 mg 6-weekly

    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

    Drug: teverelix TFA 180 mg

Interventions

  • Drugteverelix TFA 120 mg

    Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24

  • Drugteverelix TFA 180 mg

    Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24

06

What researchers measure

Primary outcomes

  1. Testosterone (T) Levels (Castrate) at Week 4

    Proportion of participants achieving castration level with serum T \<0.5 ng/mL at Day 28.

    Time frame: 4 weeks

Secondary outcomes

  1. 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

    Time frame: 4 weeks

  2. Testosterone (T) Levels (Castrate) at Week 6

    Proportion of participants achieving castration level with serum T \<0.5 ng/mL at Day 42

    Time frame: 6 weeks

  3. 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

    Time frame: 6 weeks

  4. Testosterone Levels (Castrate) at Week 24

    Proportion of participants achieving a T castration rate over 168 days of treatment period

    Time frame: 24 weeks

  5. 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

    Time frame: 24 weeks

  6. 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

    Time frame: 4 weeks

  7. Time to Escape Castrate Levels of Testosterone (T)

    Mean time to (first) overstep of T castration level after achieving castration

    Time frame: Approximately 30 weeks

  8. Luteinizing Hormone (LH) Levels (Castrate) at Week 4

    Proportion of participants achieving castration level for LH (LH \<1.1 U/L) at Day 28

    Time frame: 4 weeks

  9. Luteinizing Hormone (LH) Levels (Castrate) at Week 24

    Proportion of participants with effective LH castration rate over 168 days of treatment period

    Time frame: 24 weeks

  10. 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

    Time frame: 4 weeks

  11. Time to Escape Castrate Levels of Luteinizing Hormone (LH)

    Mean time to (first) overstep of LH castration level after achieving castration

    Time frame: 24 weeks

  12. 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)

    Time frame: 24 weeks

  13. Change in LH Levels Over Time

    The change in LH levels over time

    Time frame: 24 weeks

  14. Change in FSH Levels Over Time

    The change in FSH levels over time

    Time frame: 24 weeks

  15. 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.

    Time frame: 24 weeks

  16. 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).

    Time frame: 24 weeks

  17. Maximum Observed Plasma Teverelix Concentration After Administration (Cmax)

    The maximum observed plasma teverelix concentration after administration (Cmax)

    Time frame: 24 weeks

  18. 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)

    Time frame: 24 weeks

  19. 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)

    Time frame: 24 weeks

  20. Time to Reach Cmax After Dosing (Tmax)

    The time to reach Cmax after dosing (tmax)

    Time frame: 24 weeks

  21. Time to Reach Cmax,0-t1 After Dosing (Tmax,0-t1)

    The time to reach Cmax,0-t1 after dosing (tmax,0-t1)

    Time frame: 24 weeks

  22. Time to Reach Cmax,t1-t After Dosing (Tmax,t1-t)

    The time to reach Cmax,t1-t after dosing (tmax,t1-t)

    Time frame: 24 weeks

  23. Apparent Terminal Elimination Rate Constant (Lambda-z)

    The apparent terminal elimination rate constant (lambda-z)

    Time frame: 24 weeks

  24. Apparent Terminal Plasma Half-life (t½)

    Apparent terminal plasma half-life, calculated as: ln 2 / lambda-z

    Time frame: 24 weeks

  25. 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.

    Time frame: 24 weeks

  26. Prostate Specific Antigen (PSA) Reduction (≥50 Percent)

    Number of participants with a PSA response of ≥50 percent reduction at the Day 168 visit

    Time frame: 24 weeks

  27. 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.

    Time frame: 24 weeks

  28. PSA Response ≥50% at Day 168

    The number of subjects with a PSA response ≥50% at Day 168

    Time frame: 24 weeks

  29. Luteinizing Hormone (LH) Mean % Reduction at Day 168

    Luteinizing Hormone (LH) - the mean % reduction at Day 168

    Time frame: 24 weeks

  30. Testosterone (T) Mean % Reduction at Day 168

    Testosterone (T) - the mean % reduction at Day 168

    Time frame: 24 weeks

  31. Follicle Stimulating Hormone (FSH) Mean % Reduction at Day 168

    Follicle Stimulating Hormone (FSH) - the mean % reduction at Day 168

    Time frame: 24 weeks

  32. Treatment-emergent Adverse Events (AEs)

    Number of participants with treatment-emergent AEs

    Time frame: 24 weeks

  33. ECG QTcF Interval Prolongation >450 Msec at Day 28

    ECG QTcF Interval prolongation \>450 msec at Day 28 study visit

    Time frame: 24 weeks

  34. Injection Site Reactions (ISRs)

    Number of participants with ISRs at each visit during the 168 days treatment period

    Time frame: 24 weeks

07

Results

Posted Jul 23, 2024

Participant flow

Participant flow — Overall Study
MilestoneTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Started941
Completed532
Not completed49

Outcome measures

PrimaryTestosterone (T) Levels (Castrate) at Week 4

Proportion of participants achieving castration level with serum T \<0.5 ng/mL at Day 28.

Time frame:
4 weeks
Reported as:
Count of participants · Participants
Testosterone (T) Levels (Castrate) at Week 4
ParticipantsTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Testosterone (T) Levels (Castrate) at Week 4539
SecondaryTestosterone (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

Time frame:
4 weeks
Reported as:
Count of participants · Participants
Testosterone (T) Levels (0.2 ng/mL) at Week 4
ParticipantsTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Testosterone (T) Levels (0.2 ng/mL) at Week 4232
SecondaryTestosterone (T) Levels (Castrate) at Week 6

Proportion of participants achieving castration level with serum T \<0.5 ng/mL at Day 42

Time frame:
6 weeks
Reported as:
Count of participants · Participants
Testosterone (T) Levels (Castrate) at Week 6
ParticipantsTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Testosterone (T) Levels (Castrate) at Week 6433
SecondaryTestosterone (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

Time frame:
6 weeks
Reported as:
Count of participants · Participants
Testosterone (T) Levels (0.2 ng/mL) at Week 6
ParticipantsTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Testosterone (T) Levels (0.2 ng/mL) at Week 6126
SecondaryTestosterone Levels (Castrate) at Week 24

Proportion of participants achieving a T castration rate over 168 days of treatment period

Time frame:
24 weeks
Reported as:
Count of participants · Participants
Testosterone Levels (Castrate) at Week 24
ParticipantsTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Testosterone Levels (Castrate) at Week 24327
SecondaryTestosterone 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

Time frame:
24 weeks
Reported as:
Count of participants · Participants
Testosterone Levels (0.2 ng/mL) at Week 24
ParticipantsTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Testosterone Levels (0.2 ng/mL) at Week 24017
SecondaryTime to Achieve Castrate Levels of Testosterone (T)

Mean time to T levels falling below castration level (\<0.5 ng/mL) for the first time

Time frame:
4 weeks
Reported as:
Median · days
Time to Achieve Castrate Levels of Testosterone (T)
daysTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Time to Achieve Castrate Levels of Testosterone (T)2.0 (1.0 to 3.0)2.0 (2.0 to 3.0)
SecondaryTime to Escape Castrate Levels of Testosterone (T)

Mean time to (first) overstep of T castration level after achieving castration

Time frame:
Approximately 30 weeks
Reported as:
Median · days
Time to Escape Castrate Levels of Testosterone (T)
daysTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Time to Escape Castrate Levels of Testosterone (T)2.5 (1.0 to 123.0)215.0 (42.0 to 236.0)
SecondaryLuteinizing Hormone (LH) Levels (Castrate) at Week 4

Proportion of participants achieving castration level for LH (LH \<1.1 U/L) at Day 28

Time frame:
4 weeks
Reported as:
Count of participants · Participants
Luteinizing Hormone (LH) Levels (Castrate) at Week 4
ParticipantsTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Luteinizing Hormone (LH) Levels (Castrate) at Week 4538
SecondaryLuteinizing Hormone (LH) Levels (Castrate) at Week 24

Proportion of participants with effective LH castration rate over 168 days of treatment period

Time frame:
24 weeks
Reported as:
Count of participants · Participants
Luteinizing Hormone (LH) Levels (Castrate) at Week 24
ParticipantsTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Luteinizing Hormone (LH) Levels (Castrate) at Week 24222
SecondaryTime 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

Time frame:
4 weeks
Reported as:
Median · days
Time to Achieve Castrate Levels of Luteinizing Hormone (LH)
daysTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Time to Achieve Castrate Levels of Luteinizing Hormone (LH)1.0 (1.0 to 1.0)1.0 (1.0 to 1.0)
SecondaryTime to Escape Castrate Levels of Luteinizing Hormone (LH)

Mean time to (first) overstep of LH castration level after achieving castration

Time frame:
24 weeks
Reported as:
Median · days
Time to Escape Castrate Levels of Luteinizing Hormone (LH)
daysTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Time to Escape Castrate Levels of Luteinizing Hormone (LH)4.5 (2.0 to 83.0)8.5 (2.0 to 42.0)
SecondaryChange in Testosterone Levels Over Time (Change From Baseline at Day 168)

The change in testosterone levels over time (Change from Baseline at Day 168)

Time frame:
24 weeks
Reported as:
Mean · nmol/L
Change in Testosterone Levels Over Time (Change From Baseline at Day 168)
nmol/LTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Change in Testosterone Levels Over Time (Change From Baseline at Day 168)-16.68 ± 5.43-20.26 ± 7.37
SecondaryChange in LH Levels Over Time

The change in LH levels over time

Time frame:
24 weeks
Reported as:
Mean · IU/L
Change in LH Levels Over Time
IU/LTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Change in LH Levels Over Time-69.8825 ± 22.99177-83.3425 ± 26.87486
SecondaryChange in FSH Levels Over Time

The change in FSH levels over time

Time frame:
24 weeks
Reported as:
Mean · IU/L
Change in FSH Levels Over Time
IU/LTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Change in FSH Levels Over Time-71.8909 ± 12.83868-82.3272 ± 12.67620
SecondaryArea 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.

Time frame:
24 weeks
Reported as:
Geometric mean · h*ng/mL
Area Under the Concentration Time-curve From Time Zero up to the Last Quantifiable Concentration at Time Point t (AUC0-t)
h*ng/mLTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Area Under the Concentration Time-curve From Time Zero up to the Last Quantifiable Concentration at Time Point t (AUC0-t)16007 (10118.4 to 25316.4)27511 (23235.6 to 32573.7)
SecondaryArea 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).

Time frame:
24 weeks
Reported as:
Geometric mean · h*ng/mL
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)
h*ng/mLTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
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)1324.3 (928.2 to 1892.1)1759.3 (1581 to 1958.4)
SecondaryMaximum Observed Plasma Teverelix Concentration After Administration (Cmax)

The maximum observed plasma teverelix concentration after administration (Cmax)

Time frame:
24 weeks
Reported as:
Geometric mean · ng/mL
Maximum Observed Plasma Teverelix Concentration After Administration (Cmax)
ng/mLTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Maximum Observed Plasma Teverelix Concentration After Administration (Cmax)38.22 (30.6 to 45.9)53.1 (45.9 to 56.1)
SecondaryMaximum 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)

Time frame:
24 weeks
Reported as:
Geometric mean · ng/mL
Maximum Observed Concentration After Administration From Zero up to Time Point t1 (Cmax,0-t1)
ng/mLTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Maximum Observed Concentration After Administration From Zero up to Time Point t1 (Cmax,0-t1)38.22 (30.6 to 45.9)53.1 (45.9 to 56.1)
SecondaryMaximum 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)

Time frame:
24 weeks
Reported as:
Geometric mean · ng/mL
Maximum Observed Concentration After Administration From Time Point t1 up to Time Point t (Cmax,t1-t)
ng/mLTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Maximum Observed Concentration After Administration From Time Point t1 up to Time Point t (Cmax,t1-t)16.9 (10.2 to 25.5)20.4 (20.4 to 25.5)
SecondaryTime to Reach Cmax After Dosing (Tmax)

The time to reach Cmax after dosing (tmax)

Time frame:
24 weeks
Reported as:
Median · hours
Time to Reach Cmax After Dosing (Tmax)
hoursTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Time to Reach Cmax After Dosing (Tmax)1.8 (1.0 to 2.6)1.5 (0.9 to 3.2)
SecondaryTime to Reach Cmax,0-t1 After Dosing (Tmax,0-t1)

The time to reach Cmax,0-t1 after dosing (tmax,0-t1)

Time frame:
24 weeks
Reported as:
Median · hours
Time to Reach Cmax,0-t1 After Dosing (Tmax,0-t1)
hoursTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Time to Reach Cmax,0-t1 After Dosing (Tmax,0-t1)1.8 (1.0 to 2.6)1.5 (0.9 to 3.2)
SecondaryTime to Reach Cmax,t1-t After Dosing (Tmax,t1-t)

The time to reach Cmax,t1-t after dosing (tmax,t1-t)

Time frame:
24 weeks
Reported as:
Median · hours
Time to Reach Cmax,t1-t After Dosing (Tmax,t1-t)
hoursTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Time to Reach Cmax,t1-t After Dosing (Tmax,t1-t)96.0 (72.0 to 333.6)167 (71.0 to 527.9)
SecondaryApparent Terminal Elimination Rate Constant (Lambda-z)

The apparent terminal elimination rate constant (lambda-z)

Time frame:
24 weeks
Reported as:
Geometric mean · L/h
Apparent Terminal Elimination Rate Constant (Lambda-z)
L/hTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Apparent Terminal Elimination Rate Constant (Lambda-z)0 (0 to 0)0 (0 to 0)
SecondaryApparent Terminal Plasma Half-life (t½)

Apparent terminal plasma half-life, calculated as: ln 2 / lambda-z

Time frame:
24 weeks
Reported as:
Median · hours
Apparent Terminal Plasma Half-life (t½)
hoursTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Apparent Terminal Plasma Half-life (t½)1380.3 (198.5 to 7827)1103.1 (209.7 to 4242)
SecondaryArea 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.

Time frame:
24 weeks
Reported as:
Geometric mean · h*ng/mL
Area Under the Concentration Time-curve From Time Zero up to Infinity (∞)(AUC0-∞)
h*ng/mLTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Area Under the Concentration Time-curve From Time Zero up to Infinity (∞)(AUC0-∞)24888 (12693.9 to 48796.8)35794 (29952.3 to 42778.8)
SecondaryProstate Specific Antigen (PSA) Reduction (≥50 Percent)

Number of participants with a PSA response of ≥50 percent reduction at the Day 168 visit

Time frame:
24 weeks
Reported as:
Count of participants · Participants
Prostate Specific Antigen (PSA) Reduction (≥50 Percent)
ParticipantsTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Prostate Specific Antigen (PSA) Reduction (≥50 Percent)530
SecondaryPSA 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.

Time frame:
24 weeks
Reported as:
Count of participants · Participants
PSA Response Rate at Day 28
ParticipantsTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
PSA Response Rate at Day 28635
SecondaryPSA Response ≥50% at Day 168

The number of subjects with a PSA response ≥50% at Day 168

Time frame:
24 weeks
Reported as:
Count of participants · Participants
PSA Response ≥50% at Day 168
ParticipantsTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
PSA Response ≥50% at Day 168530
SecondaryLuteinizing Hormone (LH) Mean % Reduction at Day 168

Luteinizing Hormone (LH) - the mean % reduction at Day 168

Time frame:
24 weeks
Reported as:
Mean · % of baseline value
Luteinizing Hormone (LH) Mean % Reduction at Day 168
% of baseline valueTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Luteinizing Hormone (LH) Mean % Reduction at Day 168-69.88 ± 22.99-83.34 ± 26.87
SecondaryTestosterone (T) Mean % Reduction at Day 168

Testosterone (T) - the mean % reduction at Day 168

Time frame:
24 weeks
Reported as:
Mean · % of baseline
Testosterone (T) Mean % Reduction at Day 168
% of baselineTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Testosterone (T) Mean % Reduction at Day 168-91.1 ± 7.02-95.9 ± 4.57
SecondaryFollicle Stimulating Hormone (FSH) Mean % Reduction at Day 168

Follicle Stimulating Hormone (FSH) - the mean % reduction at Day 168

Time frame:
24 weeks
Reported as:
Mean · % of baseline
Follicle Stimulating Hormone (FSH) Mean % Reduction at Day 168
% of baselineTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Follicle Stimulating Hormone (FSH) Mean % Reduction at Day 168-71.89 ± 12.84-82.33 ± 12.68
SecondaryTreatment-emergent Adverse Events (AEs)

Number of participants with treatment-emergent AEs

Time frame:
24 weeks
Reported as:
Count of participants · Participants
Treatment-emergent Adverse Events (AEs)
ParticipantsTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Treatment-emergent Adverse Events (AEs)838
SecondaryECG QTcF Interval Prolongation >450 Msec at Day 28

ECG QTcF Interval prolongation \>450 msec at Day 28 study visit

Time frame:
24 weeks
Reported as:
Count of participants · Participants
ECG QTcF Interval Prolongation >450 Msec at Day 28
ParticipantsTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
ECG QTcF Interval Prolongation >450 Msec at Day 2813
SecondaryInjection Site Reactions (ISRs)

Number of participants with ISRs at each visit during the 168 days treatment period

Time frame:
24 weeks
Reported as:
Count of participants · Participants
Injection Site Reactions (ISRs)
ParticipantsTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Injection Site Reactions (ISRs)526

Adverse events

Collected over Until 30 days after last injection of study drug. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Teverelix TFA 120 mg 6-weekly0/9 (0%)1/9 (11.1%)8/9 (88.9%)
Teverelix TFA 180 mg 6-weekly1/41 (2.4%)1/41 (2.4%)38/41 (92.7%)
Most frequent serious events
Most frequent serious events
EventTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Left Carotid Artery StenosisVascular disorders1/90/41
benign pituitary tumourNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/90/41
cardiac arrestCardiac disorders0/91/41
Most frequent other events
Showing 10 of 30
Most frequent other events
EventTeverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weekly
Injection site indurationGeneral disorders7/930/41
Injection site erythemaGeneral disorders6/929/41
Hot flushVascular disorders4/917/41
Injection site swellingGeneral disorders3/95/41
Injection site painGeneral disorders2/90/41
ErythemaSkin and subcutaneous tissue disorders2/91/41
Electrocardiogram qt prolongedInvestigations0/95/41
Renal impairmentRenal and urinary disorders1/90/41
Atrial fibrillationCardiac disorders0/94/41
IndurationGeneral disorders0/93/41

Baseline characteristics

Safety Population

Age, Categorical
Age, Categorical(Participants)Teverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weeklyTotal
<=18 years000
Between 18 and 65 years2911
>=65 years73239
Age, Continuous
Age, Continuous(years)Teverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weeklyTotal
Mean69.0 ± 5.1269.0 ± 7.3369.0 ± 6.94
Sex: Female, Male
Sex: Female, Male(Participants)Teverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weeklyTotal
Female000
Male94150
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Teverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weeklyTotal
American Indian or Alaska Native000
Asian000
Black or African American000
Native Hawaiian or Other Pacific Islander000
White94150
Region of Enrollment
Region of Enrollment(Participants)Teverelix TFA 120 mg 6-weeklyTeverelix TFA 180 mg 6-weeklyTotal
Lithuania94150
08

Study locations

4 sites
  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
    Kaunas, LT-50161, Lithuania
  • Klaipeda University Hospital
    Klaipėda, LT-92288, Lithuania
  • National Cancer Institute
    Vilnius, LT-08660, Lithuania
  • Vilnius University Hospital Santaros Clinic
    Vilnius, LT-08661, Lithuania
09

References and documents

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 documents

  • Study protocol · May 31, 2022
  • Statistical analysis plan · Apr 24, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2021 to primary completion in Dec 2022, 21 months.

Results were first posted in Jul 2024, 1 year 7 months after primary completion.

Of 16 phase 2 interventional studies under Prostatic Hyperplasia, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 76. This study's 21 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 29, 2020
First posted
Jan 5, 2021
StartActual
Mar 4, 2021
Primary completionActual
Dec 5, 2022
CompletionActual
Feb 6, 2023
Results first posted
Jul 23, 2024
Last update
Jul 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04693507
Lead sponsor
Antev Ltd.
Responsible party
Sponsor
First posted
Jan 5, 2021
Start date
Mar 4, 2021
Primary completion
Dec 5, 2022
Completion
Feb 6, 2023
Results posted
Jul 23, 2024
Last update
Jul 23, 2024

Study contacts

Albertas Ulys, MD
principal investigator · National Cancer Institute, Vilnius, Lithuania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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