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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


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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).


Inclusion Criteria:



- 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.

- 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.

Exclusion Criteria:

- 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.

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Description:

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.

Outcome Time Frame:

Week 4 to Week 48

Safety Issue:

No

Principal Investigator

Kristof Chwalisz, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Abbott

Authority:

United States: Food and Drug Administration

Study ID:

L-PC07-169

NCT ID:

NCT00626431

Start Date:

February 2008

Completion Date:

September 2009

Related Keywords:

  • Prostate Cancer
  • Lupron Depot
  • prostate cancer
  • leuprolide acetate
  • Prostatic Neoplasms

Name

Location

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