Prostate CancerPhase 3NCT01697384
Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer
A Phase 3 study testing histrelin acetate in people with Prostate Cancer and Adenocarcinoma of the Prostate, run by Endo USA Inc., a Keenova Therapeutics Company.
Trial summary
Objective was to evaluate the efficacy and safety of the histrelin acetate subdermal implant (originally versus Lupron Depot-3 Month) in male patients with advanced prostate cancer during 52 weeks of treatment with the implant. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Cancer, Adenocarcinoma of the Prostate
- What is being tested?
- histrelin acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Apr 2000to Oct 2004
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male Age 45 or older
- Histologically confirmed adenocarcinoma of the prostate
- Disease Staging III or IV
- Clinical indication for androgen suppression therapy
- Serum testosterone at least 150 ng/dL at screening
- WHO Performance Scale 0 to 3
- Life expectancy of at least one year
Who cannot join
- Bilateral orchiectomy
- Prior androgen-ablative therapy within past year
- Second malignancy with 5 years (except adequately treated non-melanomatous skin cancer or superficial bladder cancer)
- Spinal cord compression
About this study
Official title: Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Patients With Advanced Prostate Cancer
Objective was to evaluate the efficacy and safety of the histrelin acetate subdermal implant (originally versus Lupron Depot-3 Month) in male patients with advanced prostate cancer during 52 weeks of treatment with the implant. After consultation w/ FDA, design was modified to eliminate the Lupron arm and continued the study as an open-label non-randomized study.
Primary endpoint was testosterone suppression, as assessed by the percent of patients whose testosterone indicated chemical castration levels (<=50 ng/dL) through 52 weeks of treatment with an implant.
Read the detailed description
Other outcome measures included serum levels of LH, PSA, as well as non-clinical assessments, eg, WHO Performance Status, pain level assessment, and quality of life questionnaires. Safety was evaluated via adverse events, vital signs, clinical laboratory outcomes, physical examinations, and ECGs. Local tolerability outcomes were also evaluated.
An extension period for the study included annual replacement of the implant until the implant was approved by the FDA (October 12, 2004). Efficacy and safety were followed during the extension period.
- Conditions
- Prostate Cancer, Adenocarcinoma of the Prostate
- Being tested
- histrelin acetate
- Keywords
- prostate cancer, PSA
- Medical subject headings
- Prostatic Neoplasms, Salivary Gland Adenoma, Pleomorphic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
histrelin acetateDrug
Also called Vantas
52 week implant
| Study group | Role | What they receive |
|---|---|---|
| one histrelin acetate 50 mg implant | Experimental | The test product was a histrelin acetate 50 mg hydrogel implant surgically placed subdermally into the inner aspect of the upper arm. Receives: Drug: histrelin acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suppression of testosterone to chemical castration levels (<= 50 ng/dL)
Measured: 52 weeks
Secondary outcomes (3)
PSA measurements
Measured: 52 weeks
Pain measurements
Measured: 52 weeks
QoL outcomes
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startApr 2000
- Primary completionAug 2003
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Regulatory Division, Study director, Endo Pharmaceuticals (formerly Valera/Indevus Pharmaceuticals)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697384
- Sponsor's protocol ID
- 301
- Status last verified
- Dec 2023
- First submitted
- 13 Jul 2011
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Schlegel PN; Histrelin Study Group. Efficacy and safety of histrelin subdermal implant in patients with advanced prostate cancer. J Urol. 2006 Apr;175(4):1353-8. doi: 10.1016/S0022-5347(05)00649-X.
PubMed 16515997
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Patients With Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT01697384
- Acronym / sponsor ID
- 301
- Conditions
- Prostate Cancer, Adenocarcinoma of the Prostate
- Keywords
- prostate cancer, PSA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2000
- Primary completion
- Aug 2003 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective was to evaluate the efficacy and safety of the histrelin acetate subdermal implant (originally versus Lupron Depot-3 Month) in male patients with advanced prostate cancer during 52 weeks of treatment with the implant. After consultation w/ FDA, design was modified to eliminate the Lupron arm and continued the study as an open-label non-randomized study.
Primary endpoint was testosterone suppression, as assessed by the percent of patients whose testosterone indicated chemical castration levels (<=50 ng/dL) through 52 weeks of treatment with an implant.
Detailed description
Other outcome measures included serum levels of LH, PSA, as well as non-clinical assessments, eg, WHO Performance Status, pain level assessment, and quality of life questionnaires. Safety was evaluated via adverse events, vital signs, clinical laboratory outcomes, physical examinations, and ECGs. Local tolerability outcomes were also evaluated.
An extension period for the study included annual replacement of the implant until the implant was approved by the FDA (October 12, 2004). Efficacy and safety were followed during the extension period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one histrelin acetate 50 mg implant | Experimental | Drug: histrelin acetateThe test product was a histrelin acetate 50 mg hydrogel implant surgically placed subdermally into the inner aspect of the upper arm. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male Age 45 or older
- Histologically confirmed adenocarcinoma of the prostate
- Disease Staging III or IV
- Clinical indication for androgen suppression therapy
- Serum testosterone at least 150 ng/dL at screening
Key exclusion criteria (4 listed)
- Bilateral orchiectomy
- Prior androgen-ablative therapy within past year
- Second malignancy with 5 years (except adequately treated non-melanomatous skin cancer or superficial bladder cancer)
- Spinal cord compression
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 |
|---|---|---|
| histrelin acetateAlso: Vantas52 week implant | Drug | one histrelin acetate 50 mg implant |
Primary outcome
Suppression of testosterone to chemical castration levels (<= 50 ng/dL)
Time frame: 52 weeks
3 secondary outcomes
PSA measurements
Time frame: 52 weeks
Pain measurements
Time frame: 52 weeks
QoL outcomes
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Results publication: PubMed 16515997Schlegel PN; Histrelin Study Group. Efficacy and safety of histrelin subdermal implant in patients with advanced prostate cancer. J Urol. 2006 Apr;175(4):1353-8. doi: 10.1016/S0022-5347(05)00649-X.
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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.
Regulatory Division study director
Endo Pharmaceuticals (formerly Valera/Indevus Pharmaceuticals)
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing histrelin acetate in people with Prostate Cancer and Adenocarcinoma of the Prostate, run by Endo USA Inc., a Keenova Therapeutics Company.
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 7 inclusion and 4 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 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Suppression of testosterone to chemical castration levels (<= 50 ng/dL) (time frame: 52 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 NCT01697384, 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 2 Jan 2024.