NCT00626431

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

Completed Phase 3 Results posted Last updated 15 July 2011

What this trial tests

Phase 3 trial testing Leuprolide acetate - Formulation A in Prostate Cancer in 310 participants. Completed in 1 September 2009.

Timeline

1 February 2008

Primary endpoint
1 August 2009

1 September 2009

Quick facts

Lead sponsor	Abbott
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	310
Start date	1 February 2008
Primary completion	1 August 2009
Estimated completion	1 September 2009
Sites	63 locations across United States

Drugs / interventions tested

• Leuprolide acetate - Formulation A — full drug profile →
• Leuprolide acetate - Formulation B — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Abbott — full company profile →

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 t
• 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
• 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 t

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy and safety of leuprolide acetate 6-month depot for suppression of testosterone in patients with prostate cancer.
   Spitz A, Young JM, Larsen L, Mattia-Goldberg C, et al · · 2012 · cited 30× · PMID 22025196 · DOI 10.1038/pcan.2011.50
2. Intramuscular depot formulations of leuprolide acetate suppress testosterone levels below a 20 ng/dL threshold: a retrospective analysis of two Phase III studies.
   Spitz A, Gittelman M, Karsh LI, Dragnic S, et al · · 2016 · cited 8× · PMID 27602344 · DOI 10.2147/rru.s111475
3. Accelerating Digitalization in Healthcare with the InSilicoTrials Cloud-Based Platform: Four Use Cases.
   Nicolò C, Sips F, Vaghi C, Baretta A, et al · · 2023 · cited 1× · PMID 36074307 · DOI 10.1007/s10439-022-03052-6