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

Launched by TAKEDA · Jan 5, 2009

Keywords

ClinConnect Summary

This is an open, comparative, randomized (1:1), multicenter, European (France, Germany, Czech Republic, Slovakia and Bulgaria), Phase 2B study on parallel groups of patients presenting with metastatic prostate cancer (stage D2 or Tx Nx M1 ≠ M1a), with a PSA level ≥ 5-fold higher than normal (that is PSA ≥ 20 ng/mL, as quantitated by the Hybritech radioimmunoassay) which return to normal within 6 months after the initiation of total androgen blockade therapy with leuprorelin 3.75 mg SR and flutamide. It will involve 314 preselected patients.

A minimum of 180 eligible patients are required f...

Gender

MALE

Eligibility 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.