Status:
COMPLETED
Intermittent Hormonal Therapy With Leuprorelin and Flutamide in the Treatment of Stage D2 or TxNxM1b,c
Lead Sponsor:
Takeda
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 patien...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
341 Patients enrolled
Trial Details
Trial ID
NCT00817739
Start Date
December 1 1996
End Date
December 1 2008
Last Update
July 29 2015
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