A Study of Leuprolide to Treat Prostate Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00626431
• Date of registration: 20/02/2008
• Primary sponsor: Abbott
• Public title: A Study of Leuprolide to Treat Prostate Cancer
• Scientific 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
• Date of first enrolment: February 2008
• Target sample size: 310
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00626431
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Kristof Chwalisz, MD, PhD
• Affiliation: Abbott

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Drug: Leuprolide acetate - Formulation A

Drug: Leuprolide acetate - Formulation B

Primary Outcome(s)

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]

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]

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]

Secondary Outcome(s)

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) 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) 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]

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]

Secondary ID(s)

L-PC07-169

Source(s) of Monetary Support

Please refer to primary and secondary sponsors