Intermittent Hormonal Therapy With Leuprorelin and Flutamide in the Treatment of Stage D2 or TxNxM1b,c

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study is aimed at evaluating the effects of intermittent hormonal treatment with complete androgen suppression (Leuprorelin 3.75 milligram [mg] sustained release [SR] and Flutamide) in patients presenting with stage D2 or Tx Nx M1 ≠ M1a metastatic prostrate cancer, with a prostate specific antigen (PSA) level 5-fold higher than normal (PSA greater than or equal to [≥] 20 nanogram per milliliter [ng/mL], as quantitated by the Hybritech radioimmunoassay) and with a subsequent decline to normal (PSA less than [<] 4 ng/mL) during the initial 6 months of induction treatment. The results will be compared with those obtained after continuous hormonal therapy with complete androgen suppression.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Flutamide; Leuprolide

Criteria

Inclusion Criteria:

• Histologically confirmed metastatic cancer of the prostate (stage D2 or Tx Nx M1 ≠ M1a) with measurable bone or visceral (lung, liver, etc.) metastases (radiographic conformation was necessary in the event of a questionable bone scan detection in conjunction with only slightly elevated PSA levels [at least 20 ng/mL or less than or equal to 50 ng/mL]). The prostatic carcinoma could have been diagnosed at an earlier stage and treated without castration.

• Metastatic cancer of the prostate requiring first-line therapy.

• Pre-assessment PSA 5-fold or higher than the standard level set by the central laboratory, that is, PSA greater than or equal to (≥) 20 ng/mL as quantitated by the Hybritech radioimmunoassay (normal is less than [<] 4 ng/mL).

• ECOG performance status of no more than 2.

• Normal testosterone levels according to the central laboratory standards.

• Aspartate transaminase (AST) and alanine transaminase (ALT) < 2.25-fold higher than the standard levels set by the central laboratory (except when liver metastases were present).

• Anticipated life expectancy greater than 9 months.

• Written informed consent given to participate and collaborate in the study. Inclusion Criteria for Continuous or Intermittent Treatment Phase

• Subjects who meet the pre-assessment criteria and who has PSA < 4 ng/mL after 6 months of induction therapy.

Exclusion Criteria:

• Subject refuse to sign the informed consent form or is likely to be uncooperative or not to comply with the obligations set out in the study protocol.

• Subject has received prior hormonal (and neoadjuvant) treatment prompting medical castration (estrogens, hormone-releasing hormone agonists, androgens) or has undergone surgical castration.

• Subject has undergone bilateral suprarenalectomy or hypophysectomy.

• Subject had another cancer (except basiloma) with the past 5 years.

• Subject has serious unstable progressive disease (renal, hepatic, cardiovascular, psychological, etc).

• Subject is receiving or has received another experimental treatment within 3 months prior to inclusion.

Exclusion Criteria for Continuous or Intermittent Treatment Phase

-Subjects who met the pre-assessment criteria and who, after 6 months of induction therapy, had PSA ≥ 4 ng/mL and/or on-treatment signs of disease progression.