Prostate CancerPhase 3NCT00626431

A Study of Leuprolide to Treat Prostate Cancer

A Phase 3 study testing Leuprolide acetate - Formulation A and Leuprolide acetate - Formulation B in people with Prostate Cancer, run by Abbott at 63 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: Leuprolide acetate - Formulation A and Leuprolide acetate - Formulation B
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 310 participants
Where: 63 sitesUnited States
Study dates: Feb 2008to Sep 2009
Phase: Phase 3
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 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Voluntarily sign an IRB-approved informed consent form and any required privacy statement/authorization form.
Pre-trial serum testosterone level >150 ng/dL.
Histologically-confirmed prostatic adenocarcinoma in Jewett Clinical Stage A2, B, C or D and TNM* classification cT1b-4, N: any, M: any.
Tumor/Nodes/Metastases
Subjects with a rising PSA following radical prostatectomy defined as an increase of 0.2 ng/mL from the previous test on two consecutive testings or rising PSA following prostate irradiation using Phoenix Definition of a rise of greater than or equal to 2.0 ng/mL above the nadir.
Prostate cancer and general clinical status is sufficient to warrant at least 48 weeks of continuous androgen deprivation treatment, without concomitant antiandrogen treatment.

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Eastern Cooperative Oncology Group (ECOG) Performance status grades 0,1,or 2 at the time of pre-trial screening.
Life expectancy of at least 18 months.
Subjects with serum creatinine ≤1.9 mg/dL, bilirubin ≤2.0 mg/dL (unless Gilbert's syndrome with normal AST, ALT); AST and ALT ≤2.5 times the upper limit of normal.

Who cannot join

Requires additional treatment including radical prostatectomy, radiotherapy or cryotherapy of local disease.
Historical, clinical, or radiographic evidence of central nervous system metastases, including spinal cord metastasis.
Clinical evidence of urinary tract obstruction.
History of bilateral orchiectomy, adrenalectomy, or hypophysectomy.
History of clinical hypogonadism.
Current malignancy or history of malignancy except for prostate cancer or basal or squamous cell carcinoma of the skin.

Show all 18Show fewer

Clinical or laboratory evidence of any severe underlying disease state (excluding prostate cancer) that would place subjects in additional jeopardy by participating in this trial.
Hypersensitivity to leuprolide, polylactic acid, or any excipient of the drug.
Incomplete recovery from the effects of any major surgery.
History of receiving of the following prostate cancer therapies within 8 weeks prior to the Screening Visit: chemotherapy, immunotherapy, antiandrogen, radiation therapy, cryotherapy, strontium, or biological response modifiers.
History of prostatic surgery within 4 weeks prior to the Screening Visit.
Received hormonal therapy, including GnRH analogs (less than or equal to 6 month depot administration), estrogen, Megace and phytotherapy, within 32 weeks prior to the Screening Visit and during the trial.
Alternative medical therapies which have an estrogenic, androgenic, or antiandrogenic effect (including phyto-estrogens and phyto-androgens) within 12 weeks prior to the Screening Visit and during the trial.
Requires the chronic use of systemic corticosteroids and anticonvulsants that may affect bone loss such as carbamazepine, phenobarbital, phenytoin, valproic acid or primidone.
May require antiandrogen, immuno-, or surgical therapy for prostate cancer during the trial.
History of alcoholism or consumes >14 alcoholic beverages per week or illicit drug abuse within 12 months prior to screening.
Received therapy with a GnRH analog (1 year implant) within 60 weeks prior to the Screening Visit.
Received therapy with finasteride or ketoconazole within 1 week prior to the Screening Visit; dutasteride within 25 weeks prior to the Screening Visit.

Trial locations and contacts

63 sites in 1 country.

City, postcode or hospital

63 sites in 1 country

United States63 sites

Site Reference ID/Investigator# 8691
Anaheim, California, 92801
Site Reference ID/Investigator# 8569
Anchorage, Alaska, 99508
Site Reference ID/Investigator# 8566
Atherton, California, 94027
Site Reference ID/Investigator# 8655
Aventura, Florida, 33180
Site Reference ID/Investigator# 8563
Bala-Cynwyd, Pennsylvania, 19004
Site Reference ID/Investigator# 8678
Bethany, Oklahoma, 73008
Site Reference ID/Investigator# 8696
Birmingham, Alabama, 35209
Site Reference ID/Investigator# 8680
Charlotte, North Carolina, 28209
Site Reference ID/Investigator# 8663
Cincinnati, Ohio, 45212
Site Reference ID/Investigator# 8567
Columbus, Ohio, 43220
Site Reference ID/Investigator# 8673
Concord, North Carolina, 28025
Site Reference ID/Investigator# 8641
Dallas, Texas, 75231
Site Reference ID/Investigator# 8648
Daytona Beach, Florida, 32114
Site Reference ID/Investigator# 8668
Denver, Colorado, 80211
Site Reference ID/Investigator# 8646
Englewood, Colorado, 80113
Site Reference ID/Investigator# 8693
Fort Wayne, Indiana, 46825
Site Reference ID/Investigator# 8686
Fresno, California, 93720
Site Reference ID/Investigator# 8643
Germantown, Tennessee, 38138
Site Reference ID/Investigator# 8695
Germantown, Tennessee, 38138
Site Reference ID/Investigator# 8676
Greenbelt, Maryland, 20770
Site Reference ID/Investigator# 8681
Homewood, Alabama, 35209
Site Reference ID/Investigator# 8675
Houston, Texas, 77024
Site Reference ID/Investigator# 8698
Laguna Hills, California, 92653
Site Reference ID/Investigator# 8692
Lancaster, Pennsylvania, 17604-3200
Site Reference ID/Investigator# 8653
Las Vegas, Nevada, 89148
Site Reference ID/Investigator# 8667
Lawrenceville, New Jersey, 08648
Site Reference ID/Investigator# 9705
Little Rock, Arkansas, 72211
Site Reference ID/Investigator# 9703
Long Beach, California, 90806
Site Reference ID/Investigator# 8674
Los Angeles, California, 90015
Site Reference ID/Investigator# 8685
Memphis, Tennessee, 38119
Site Reference ID/Investigator# 8652
Middlebury, Connecticut, 06762
Site Reference ID/Investigator# 8689
Myrtle Beach, South Carolina, 29572
Site Reference ID/Investigator# 8564
Nashville, Tennessee, 37209
Site Reference ID/Investigator# 8645
Nashville, Tennessee, 37232-2765
Site Reference ID/Investigator# 8697
New Britain, Connecticut, 06052
Site Reference ID/Investigator# 8660
New Smyrna Beach, Florida, 32168
Site Reference ID/Investigator# 8665
New York, New York, 10016
Site Reference ID/Investigator# 8690
Newburgh, Indiana, 47630
Site Reference ID/Investigator# 8672
Norfolk, Virginia, 23502
Site Reference ID/Investigator# 8658
Orange City, Florida, 32763
Site Reference ID/Investigator# 8664
Orlando, Florida, 32803
Site Reference ID/Investigator# 8565
Overland Park, Kansas, 66211
Site Reference ID/Investigator# 9709
Phoenix, Arizona, 85013
Site Reference ID/Investigator# 8657
Poughkeepsie, New York, 12601
Site Reference ID/Investigator# 8666
Raleigh, North Carolina, 27607
Site Reference ID/Investigator# 8669
Richmond, Virginia, 23235
Site Reference ID/Investigator# 8670
Roswell, Georgia, 30076
Site Reference ID/Investigator# 8651
Saint Augustine, Florida, 32086
Site Reference ID/Investigator# 8570
Salisbury, North Carolina, 28144
Site Reference ID/Investigator# 8683
Salt Lake City, Utah, 84107
Site Reference ID/Investigator# 8684
San Antonio, Texas, 78229
Site Reference ID/Investigator# 8662
Sierra Vista, Arizona, 85635
Site Reference ID/Investigator# 8661
St. Petersburg, Florida, 33710
Site Reference ID/Investigator# 8568
Tallahassee, Florida, 32308
Site Reference ID/Investigator# 8650
Tarzana, California, 91356
Site Reference ID/Investigator# 9702
The Bronx, New York, 10461
Site Reference ID/Investigator# 9708
Thomasville, Georgia, 31799
Site Reference ID/Investigator# 8699
Torrance, California, 90505
Site Reference ID/Investigator# 8656
Tucson, Arizona, 85710
Site Reference ID/Investigator# 8649
Tyler, Texas, 75701
Site Reference ID/Investigator# 8679
Wellington, Florida, 33414
Site Reference ID/Investigator# 8562
West Palm Beach, Florida, 33407
Site Reference ID/Investigator# 8644
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Phase 3, Multi-Center, Open-Label, Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of Two 6-Month Leuprolide Formulations, in Subjects With Prostatic Adenocarcinoma

To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A formulation will be deemed successful if the percentage of subjects with suppression of testosterone to <= 50 ng/dL from Week 4 to Week 48 is not less than 87%, (the lower bound of the 2-sided 90% confidence interval), a protocol-specified criterion.

Read the detailed description

A total of 300 male subjects were planned to be enrolled. Subjects were to receive a total of 2 intramuscular (IM) injections of the same formulation, either Formulation A or Formulation B, administered 24 weeks apart. The first 150 subjects were to receive Formulation A for both injections and the next 150 subjects were to receive Formulation B for both injections. The sponsor was to conduct an ongoing review of the primary endpoint data (suppression of testosterone <= 50 ng/dL) and planned to stop enrollment of Formulation A or Formulation B, or not to administer the second injection of Formulation A or Formulation B, if 15 or more subjects did not achieve testosterone suppression by Week 4 or failed to maintain testosterone suppression during the treatment period.

All analyses and summaries were to be conducted separately for subjects who received Formulation A or Formulation B.

This study was to be conducted at approximately 60-80 investigative sites. Subjects participated in the trial for approximately 14 months.

This trial was to include a Screening Period (up to 4 weeks), a 12-month Treatment Period (two 6-month treatment cycles), and a Follow-Up Period (30 days).

Conditions: Prostate Cancer
Being tested: Leuprolide acetate - Formulation A, Leuprolide acetate - Formulation B
Keywords: Lupron Depot, prostate cancer, leuprolide acetate
Medical subject headings: Prostatic Neoplasms

What participants receive

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

Leuprolide acetate - Formulation ADrug
Also called Lupron, leuprorelin, gonadotropin hormone-releasing hormone (GnRH), luteinizing hormone-releasing hormone (LHRH)
Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation A, 45 mg 6 month depot, 24 weeks apart.
Leuprolide acetate - Formulation BDrug
Also called Lupron, leuprorelin, gonadotropin hormone-releasing hormone (GnRH), luteinizing hormone-releasing hormone (LHRH)
Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation B, 45 mg 6 month depot, 24 weeks apart.

Study groups in NCT00626431
Study group	Role	What they receive
Leuprolide acetate - Formulation A	Experimental	Leuprolide acetate 45 mg, 6-month depot Receives: Drug: Leuprolide acetate - Formulation A
Leuprolide acetate - Formulation B	Experimental	Leuprolide acetate, 45 mg, 6-month depot Receives: Drug: Leuprolide acetate - Formulation B

What is being measured

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

Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: Intent-to-treat (ITT) Population for the Primary Endpoint.
The percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 48). The 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.
Measured: Week 4 to Week 48
Adjusted Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: ITT Population for the Primary Endpoint Adjusted
The adjusted percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. The primary efficacy analysis was adjusted to censor subjects who received an anti-androgen at the last testosterone measurement before use of the anti-androgen. One additional subject was censored because of a laboratory error, at the last measurement before the error. The adjusted 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.
Measured: Week 4 to Week 48
Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation B: ITT Population for the Primary Endpoint Preplanned
The percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 48). The 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.
Measured: Week 4 to Week 48

Secondary outcomes (8)

Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population
Baseline was the last measurement before the first dose of Formulation A. The mean +/- standard error was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.
Measured: Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population
Baseline was the last measurement before the first dose of Formulation B. The mean +/- standard error was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.
Measured: Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit
Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation A: ITT Population
The acute-on-chronic effect is an agonistic stimulation of serum testosterone after the second depot injection of Formulation A. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.
Measured: Week 24 before the second injection until 2 weeks after Week 24 (2 hours [h], 4 h, 8 h, 1 day [d], 2 d, 3-10 d, and 11-17 d postdose)
Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation B: ITT Population
The acute-on-chronic effect is an agonistic stimulation of serum testosterone after the second depot injection of Formulation B. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.
Measured: Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose)
Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation A: ITT Population
The acute-on-chronic effect is an agonistic stimulation of luteinizing hormone after the second depot injection of Formulation A. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.
Measured: Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose)
Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation B: ITT Population
The acute-on-chronic effect is an agonistic stimulation of luteinizing hormone after the second depot injection of Formulation B. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.
Measured: Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose)
Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation A: ITT Population
PSA levels were measured at baseline and each treatment visit for Formulation A. The mean (+/- standard error) was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.
Measured: Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final Visit
Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation B: ITT Population
PSA levels were measured at baseline and each treatment visit for Formulation B. The mean (+/- standard error) was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.
Measured: Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final Visit

Timeline

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

Feb 2008Sep 2009

First posted29 Feb 2008 (estimated)
Study startFeb 2008
Primary completionAug 2009
Study completionSep 2009

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 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 310 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00626431
Sponsor's protocol ID: L-PC07-169
Status last verified: Jul 2011
First submitted: 20 Feb 2008
Last updated: 19 Jul 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Spitz A, Young JM, Larsen L, Mattia-Goldberg C, Donnelly J, Chwalisz K. Efficacy and safety of leuprolide acetate 6-month depot for suppression of testosterone in patients with prostate cancer. Prostate Cancer Prostatic Dis. 2012 Mar;15(1):93-9. doi: 10.1038/pcan.2011.50. Epub 2011 Oct 25.
PubMed 22025196

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Recruiting
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All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multi-Center, Open-Label, Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of Two 6-Month Leuprolide Formulations, in Subjects With Prostatic Adenocarcinoma
ClinicalTrials.gov ID: NCT00626431
Acronym / sponsor ID: L-PC07-169
Conditions: Prostate Cancer
Keywords: Lupron Depot, prostate cancer, leuprolide acetate
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 310 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Aug 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 29 Feb 2008 (estimated)
Results: Posted 1 Nov 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

All analyses and summaries were to be conducted separately for subjects who received Formulation A or Formulation B.

This study was to be conducted at approximately 60-80 investigative sites. Subjects participated in the trial for approximately 14 months.

This trial was to include a Screening Period (up to 4 weeks), a 12-month Treatment Period (two 6-month treatment cycles), and a Follow-Up Period (30 days).

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Leuprolide acetate - Formulation A	Experimental	Drug: Leuprolide acetate - Formulation ALeuprolide acetate 45 mg, 6-month depot
Leuprolide acetate - Formulation B	Experimental	Drug: Leuprolide acetate - Formulation BLeuprolide acetate, 45 mg, 6-month depot

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Voluntarily sign an IRB-approved informed consent form and any required privacy statement/authorization form.
Pre-trial serum testosterone level >150 ng/dL.
Histologically-confirmed prostatic adenocarcinoma in Jewett Clinical Stage A2, B, C or D and TNM* classification cT1b-4, N: any, M: any.
Tumor/Nodes/Metastases
Subjects with a rising PSA following radical prostatectomy defined as an increase of 0.2 ng/mL from the previous test on two consecutive testings or rising PSA following prostate irradiation using Phoenix Definition of a rise of greater than or equal to 2.0 ng/mL above the nadir.

Key exclusion criteria (18 listed)

Requires additional treatment including radical prostatectomy, radiotherapy or cryotherapy of local disease.
Historical, clinical, or radiographic evidence of central nervous system metastases, including spinal cord metastasis.
Clinical evidence of urinary tract obstruction.
History of bilateral orchiectomy, adrenalectomy, or hypophysectomy.
History of clinical hypogonadism.

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
Leuprolide acetate - Formulation AAlso: Lupron, leuprorelin, gonadotropin hormone-releasing hormone (GnRH), luteinizing hormone-releasing hormone (LHRH)Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation A, 45 mg 6 month depot, 24 weeks apart.	Drug	Leuprolide acetate - Formulation A
Leuprolide acetate - Formulation BAlso: Lupron, leuprorelin, gonadotropin hormone-releasing hormone (GnRH), luteinizing hormone-releasing hormone (LHRH)Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation B, 45 mg 6 month depot, 24 weeks apart.	Drug	Leuprolide acetate - Formulation B

Primary outcome

Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: Intent-to-treat (ITT) Population for the Primary Endpoint.
Time frame: Week 4 to Week 48
The percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 48). The 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.
Adjusted Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: ITT Population for the Primary Endpoint Adjusted
Time frame: Week 4 to Week 48
The adjusted percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. The primary efficacy analysis was adjusted to censor subjects who received an anti-androgen at the last testosterone measurement before use of the anti-androgen. One additional subject was censored because of a laboratory error, at the last measurement before the error. The adjusted 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.
Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation B: ITT Population for the Primary Endpoint Preplanned
Time frame: Week 4 to Week 48
The percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 48). The 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.

8 secondary outcomes

Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population
Time frame: Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population
Time frame: Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit
Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation A: ITT Population
Time frame: Week 24 before the second injection until 2 weeks after Week 24 (2 hours [h], 4 h, 8 h, 1 day [d], 2 d, 3-10 d, and 11-17 d postdose)
Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation B: ITT Population
Time frame: Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose)
Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation A: ITT Population
Time frame: Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose)
Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation B: ITT Population
Time frame: Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose)
Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation A: ITT Population
Time frame: Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final Visit
Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation B: ITT Population
Time frame: Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final Visit

Results and safety

Results posted to the registry on 1 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Leuprolide Acetate - Formulation A	151	134
Leuprolide Acetate - Formulation B	159	114

Primary outcome: Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: Intent-to-treat (ITT) Population for the Primary Endpoint.

Time frame: Week 4 to Week 48. Number (90% Confidence Interval). Unit: Percent Suppressed

Measure	Leuprolide Acetate - Formulation A n = 148
Value	93.6 (2.05)

Population analysed: The ITT population for the primary endpoint was the same as the ITT population for the secondary endpoints and also excluded subjects whose final testosterone values were measured before Day 19 without suppression (\>50 ng/dL) or whose testosterone levels remained suppressed through Week 48 but testosterone levels were not measured at Week 4.

Primary outcome: Adjusted Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: ITT Population for the Primary Endpoint Adjusted

Time frame: Week 4 to Week 48. Number (90% Confidence Interval). Unit: Percent Suppressed

Measure	Leuprolide Acetate - Formulation A n = 148
Value	93.4 (89.9 to 96.9)

Primary outcome: Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation B: ITT Population for the Primary Endpoint Preplanned

Time frame: Week 4 to Week 48. Number (90% Confidence Interval). Unit: Percent suppressed

Measure	Leuprolide Acetate - Formulation B n = 154
Value	86.9 (82.2 to 91.7)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Leuprolide Acetate - Formulation A	31 of 151 (20.5%)	133 of 151 (88.1%)	Not reported
Leuprolide Acetate - Formulation B	41 of 159 (25.8%)	127 of 159 (79.9%)	Not reported

Limitations and caveats (from the sponsor): Treatment with Formulation B was prematurely discontinued as testosterone was not adequately suppressed to \<= 50 ng/dL or escapes from suppression occurred. Subjects who had not received dose 2 of Formulation B were discontinued after Week 24.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22025196Spitz A, Young JM, Larsen L, Mattia-Goldberg C, Donnelly J, Chwalisz K. Efficacy and safety of leuprolide acetate 6-month depot for suppression of testosterone in patients with prostate cancer. Prostate Cancer Prostatic Dis. 2012 Mar;15(1):93-9. doi: 10.1038/pcan.2011.50. Epub 2011 Oct 25.

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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.

Kristof Chwalisz, MD, PhD study director

Abbott

63 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Leuprolide acetate - Formulation A and Leuprolide acetate - Formulation B in people with Prostate Cancer, run by Abbott at 63 sites in United States.

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 9 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 19 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States. 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?

Yes. Results are posted in the registry (first posted 1 Nov 2010). 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?

Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: Intent-to-treat (ITT) Population for the Primary Endpoint. (time frame: Week 4 to Week 48). The study lists 3 primary outcomes in all. 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 NCT00626431, 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 19 Jul 2011.