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Evaluation of Two Doses of SR31747A (75 mg and 125 mg) in Non-Metastatic Androgen-Independent Prostate Cancer. Randomized, Double-Blind, Placebo Controlled Phase II Study


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostatic Neoplasm

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Trial Information

Evaluation of Two Doses of SR31747A (75 mg and 125 mg) in Non-Metastatic Androgen-Independent Prostate Cancer. Randomized, Double-Blind, Placebo Controlled Phase II Study


Inclusion Criteria:



- Prior confirmed histological diagnosis of prostatic carcinoma.

- Rising PSA while receiving hormonal therapy or after surgical castration defined as 2
sequential increases above a previous lowest reference value within the past 12
months; PSA must be at least 4ng/ml at the time of study entry.

- No distant metastases as evidenced by bone scan (+ or - centered X-Ray or MRI), and
spiral thoracoabdominopelvic CT scan.

- Effective castration throughout the study. Any prior anti-androgen therapy should be
stopped with documented continued elevation of PSA 4 weeks after the cessation of
flutamide (6 weeks for bicalutamide).

- Serum testosterone levels < 50ng/dL at the time of progression and throughout the
study.

- Age > or = to 18 years.

- Extensive metabolizer by CYP2D6 genotyping.

- Karnofsky Performance Status > or = to 70% and life expectancy > 6 months.

- Adequate hematological, renal and liver function.

- Signed written informed consent

Exclusion Criteria:

- Poor metabolizers by CYP2D6 genotyping.

- Prior palliative radiotherapy or any prior chemotherapy or experimental therapy.

- More than one line of any prior anticancer treatment with estrogen (estrogen or
estramustine) if discontinued at least 4 weeks before study entry.

- Concomitant administration of biphosphonate or chronic corticosteroids.

- Presence of progressive symptoms not adequately controlled with non opioid
medications

- Concomitant use of medications known to be cytochrome P450 2D6 inhibitors as listed
in protocol appendice

- Previous malignancies except if there has been a disease-free interval of at least 5
years and except curatively treated non-melanoma skin cancer

- Other serious illness or medical condition, which would not permit the patient to be
managed according to the protocol.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Time To Clinical Progression assessed by every 4 weeks clinical examination and every 12 weeks radiological examinations (Thoraco-abdominopelvic CT scan ; Bone scan ± centered Bone X-rays, MRI)

Principal Investigator

B. TOMBAL, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UCL St Luc, Bruxelles BELGIUM

Authority:

Canada: Health Canada

Study ID:

EFC5378

NCT ID:

NCT00174863

Start Date:

October 2003

Completion Date:

August 2006

Related Keywords:

  • Prostatic Neoplasm
  • Neoplasms
  • Prostatic Neoplasms

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