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Advanced Prostate AdenocarcinomaPhase 3NCT04914195

Leuprolide Acetate 3.75 mg Depot Injection for Patients With Advanced Prostate Cancer

A Phase 3 study testing Leuprolide Acetate 3.75 MG/ML in people with Advanced Prostate Adenocarcinoma, run by Bharat Serums and Vaccines Limited at 2 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Randomized, Active Controlled, Comparative, Open-Label, Multi-Center, Phase 3 clinical study to compare the efficacy, safety, and pharmacokinetics of leuprolide acetate for injection 3.75mg (depot) of two brands (Luprodex and Lucrin) administered in subjects with advanced adenocarcinoma of the prostate. Read more about this study

Who is it for?
Ages 18 to 99 years, men only
Conditions the study is for
Advanced Prostate Adenocarcinoma
What is being tested?
Leuprolide Acetate 3.75 MG/ML
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
2 sitesIndia
Study dates
1 Jul 2021to 29 Sep 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 18 to 99 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male subjects aged above 18 years.
  • Histologically or cytologically confirmed adenocarcinoma of the prostate at stage T1b-4, Nany, Many in subjects, who would benefit from a GnRH agonist.
  • Baseline Testosterone of >1.50 ng/mL or >150 ng/dL.
  • For subjects with radical prostatectomy, an increase of 0.2 ng/mL or 20 ng/dL in PSA from previous test on two consecutive tests. For subjects with prostate irradiation a rise of greater than or equal to 2.0 ng/mL or 200 ng/dL PSA above the nadir.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Appendix 2).
  • Life expectancy of at least 6 months from screening.
  • Adequate organ and immune system function
  • Willing to participate and sign the informed consent as per regulatory requirements.

Who cannot join

  • Evidence of brain metastases.
  • Evidence of spinal cord compression.
  • Evidence of urinary tract obstruction, where a flare in disease could put subject at significant risk in the opinion of the Investigator.
  • Received prostate cancer therapies like immunotherapy (antibody therapies, tumor vaccines), external radiotherapy, brachytherapy, chemotherapy or biological response modifiers (e.g. cytokines) within two months of enrollment.
  • Undergone any prostate surgery (e.g. transurethral resection of the prostate (TURP), radical prostatectomy) within two weeks of enrollment.
  • Under the effects of any other hormonal therapy, including anti-androgens for treatment of prostate cancer within three months of baseline.
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  • Received leuprolide (leuprorelin) previously.
  • Had an orchiectomy, adrenalectomy or hypophysectomy.
  • Had used any investigational drug, biologic, or device within five half-lives of its physiological action or three months, whichever is longer, before enrollment.
  • Anticipated to need concomitant hormonal, anti-androgen, radiotherapy, chemotherapy, immunotherapy or surgical therapy for prostate cancer throughout the duration of the study.
  • Used over-the-counter (OTC) or alternative medical therapies which has an estrogenic or anti-androgenic effect (e.g., Glycyrrhiza, Dehydroepiandrosterone (DHEA), PC-SPES, saw palmetto) within three months prior to enrollment.
  • Used finasteride, dutasteride, estrogens, megestrol acetate, anti-androgens (Bicalutamide, Flutamide, or Cyproterone), and ketoconazole within three months prior to baseline.
  • Co-existent malignancy or a history of malignancy, with the exception of basal and/or squamous cell carcinomas of the skin.
  • Uncontrolled congestive heart failure within six months before baseline.
  • Experienced a myocardial infarction or a coronary vascular procedure (e.g. balloon angioplasty, coronary artery bypass graft surgery) within six months before baseline.
  • Significant symptomatic cardiovascular disease within six months of baseline.
  • Experienced venous thrombosis within six months of baseline.
  • Uncontrolled hypertension (≥160/100 mmHg) or symptomatic hypotension within three months before baseline.
  • Insulin-dependent diabetes mellitus (Type I diabetes mellitus).
  • History of drug abuse within six months of baseline.
  • Serious intercurrent illnesses or diseases (e.g. hematological, renal, hepatic, respiratory, endocrine, psychiatric) that might interfere with the treatment outlined in the protocol.
  • Receiving anticoagulants or antiplatelet medications and not receiving a stable dose for three months before baseline. Receiving warfarin-derivative anticoagulants with International normalized ratio (INR) outside therapeutic range for the clinical indication for which the anticoagulant has been prescribed.
  • Known hypersensitivity to GnRH, GnRH agonists or any excipients of Leuprolide (leuprorelin).
  • Positive test for HIV, HCV, HbsAg at Screening.
  • History of:
  • Immunization within four weeks of baseline
  • Flu shots within two weeks of baseline
  • Donation or receipt of blood or blood products within two months of baseline
  • Anaphylaxis
  • Skin disease which would interfere with injection site evaluation
  • Dermatographism (Physical urticaria).

Trial locations and contacts

2 sites in 1 country.

India2 sites

  • MV hospital and Research Center

    Lucknow, Uttar Pradesh, 226003

  • Government Med ical College & Superspeciality Hospital Nagpur

    Nagpur, Maharashtra, 440009

Other trials in India

About this study

Official title: Efficacy, Safety, and Pharmaco-kinetics of Leuprolide Acetate for Injection 3.75mg (Depot) (Leuprorelin) Administered in Subjects With Advanced Adenocarcinoma of Prostate: A Randomized, Active Controlled, Comparative, Open-Label, Multi-Center, Phase 3 Study

This is a Randomized, Active Controlled, Comparative, Open-Label, Multi-Center, Phase 3 clinical study to compare the efficacy, safety, and pharmacokinetics of leuprolide acetate for injection 3.75mg (depot) of two brands (Luprodex and Lucrin) administered in subjects with advanced adenocarcinoma of the prostate.

Approximately 168 subjects (males )of age above 18 years fulfilling the eligibility criteria will be enrolled. The IP will be given as a monthly dose for two cycles on day 0 and day 28.

The pharmacokinetic analysis will be done for 12 patients receiving Luprodex. The primary and secondary outcomes will be captured on days as per protocol. Adverse events will be noted for safety evaluation.

Being tested
Leuprolide Acetate 3.75 MG/ML

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Leuprolide Acetate 3.75 MG/MLDrug

    Leuprolide Acetate/ Leuprorelin is a depot injection administered as a subcutaneous injection once every month.

Study groups in NCT04914195
Study groupRoleWhat they receive
Leuprolide acetate 3.75 mg Depot (Luprodex)ExperimentalWill be administered subcutaneously once a month for two cycles, on day 0 and on day 28/29
Receives: Drug: Leuprolide Acetate 3.75 MG/ML
Leuprolide acetate 3.75 mg Depot (Lucrin)Active comparatorWill be administered subcutaneously once a month for two cycles, on day 0 and on day 28/29
Receives: Drug: Leuprolide Acetate 3.75 MG/ML

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Testosterone response rate defined as Testosterone values sustained below castration level (0.5 ng/mL or 50 ng/dL) i.e. all Testosterone values at and after Day 28 until Day 57 must be < 0.5 ng/mL or < 50 ng/dL

    Measured: From Day 28 to day 57

Secondary outcomes (9)

  1. Percentage of subjects who have reached castration level of Testosterone at the last visit (Day 57)

    Measured: Day 57

  2. Percentage of breakthrough responses defined as a single total serum Testosterone value of >0.5 ng/mL or >50 ng/dL measured after achieving a castration Testosterone level

    Measured: from Day 28 to Day 57

  3. Time after first implantation until castration level of Testosterone is achieved

    Measured: up to Day 28

  4. Percentage of subjects with Testosterone values sustained below 0.2 ng/mL or 20 ng/dL at and after Day 28 until Day 57

    Measured: From Day 28 to Day 57

  5. Change from baseline in Luteinizing hormone (LH) levels at Day 28 and 57

    Measured: from baseline to Day 28 and from baseline to Day 57

  6. Change from baseline in Follicle Stimulating Hormone (FSH) levels at Day 28 and Day 57

    Measured: from baseline to Day 28 and from baseline to Day 57

  7. Change from baseline in Prostate-specific antigen (PSA) at Day 57

    Measured: Day 57

  8. Mean number of days of maintaining testosterone castration levels (mean number of castration days)

    Measured: day 28 to day 57

  9. Mean maximum testosterone concentration during the dosing period after reaching the castration level

    Measured: Day 28 to Day 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2021
  2. Study start1 Jul 2021
  3. Primary completion29 Sep 2022
  4. Study completion29 Sep 2022

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04914195
Sponsor's protocol ID
BSV_LEUPR_18_05
Status last verified
Jul 2023
First submitted
31 May 2021
Last updated
1 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Leuprolide Acetate 3.75 MG/ML in people with Advanced Prostate Adenocarcinoma, run by Bharat Serums and Vaccines Limited at 2 sites in India.

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 8 inclusion and 31 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 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in India. 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?

Testosterone response rate defined as Testosterone values sustained below castration level (0.5 ng/mL or 50 ng/dL) i.e. all Testosterone values at and after Day 28 until Day 57 must be < 0.5 ng/mL or < 50 ng/dL (time frame: From Day 28 to day 57). 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 NCT04914195.

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 1 Aug 2023.

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