EUCTR2007-004545-15-NLActive, not recruitingNot Applicable
The Split Dose Study: Split dose Rhenium-188-HEDP regimen in hormone refractory prostate cancer patients with bone metastases; a phase I toxicity study and phase II efficacy study. - The Split Dose Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •Related to prostate cancer:
- •1.Histologically documented adenocarcinoma of the prostate.
- •2.Presence of more than one osteoblastic bone metastasis confirmed by 99mTc-labeled
- •bisphosphonates bone scan performed within 8 weeks prior to study entry.
- •3.Clinically progressive hormone refractory disease, as documented by one or more of the following:
- •a.Two documented consecutive increases in total PSA over a previous reference value (first increase at least one week after reference value). Increased total
- •PSA level must be at least 5 µg/L.
- •b.New lesion on bone scan (progressive measurable disease).
- •c.Increase in bidimensionally measurable disease.
- •4.Karnofsky performance status ? 60% (Appendix III).
- •5.Life expectancy of at least 3 months.
- •6.Patients with lower urinary tract obstruction or incontinence must consent to
- •catheterization of the bladder for up to 8 hours after administration of Re-188-HEDP .
- •Related to previous or concomitant therapies:
- •7.Patients receiving anti-androgen treatment can either stop or continue their treatment.
- •Patients who stop anti-androgens must demonstrate no decrease in total PSA values on
- •at least two occasions at least 1 week apart after anti-androgen withdrawal. Flutamide
- •must be discontinued for 4 weeks, and bicalutamide, megestrol acetate, cyproterone
- •acetate, or nilutamide must be discontinued for at least 6 weeks prior to study entry.
- •Patients who continue anti-androgen treatment must go on with their treatment during
- •the whole study period.
- •8.Patients under LH-RH agonists must continue their treatment.
- •Related to the patient:
- •9.Age ? 18 years.
- •10.Ability to understand and willingness to sign a written informed consent document.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Related to prostate cancer:
- •1.Patients with pathologic long-bone fractures (unless surgically stabilized), imminent
- •pathologic long-bone fracture (cortical erosion on radiography > 50%), or clinical
- •evident spinal cord compression.
- •2.Patient known to have a malignancy other than prostate cancer (but not including basal
- •cell carcinoma of the skin).
- •Related to previous or concomitant therapies:
- •3.Previous chemotherapy (including Estramustine) within 6 weeks prior to screening.
- •4.Any other medicine taken with the intension to treat the disease (except LH-RH
- •5.Use of Interferon-alpha, Allopurinol, Sorivudine and analogues and Folinic acid.
- •6.Prior treatment with a systemic radiotherapeutic bone agent (only Sm-153-HEDP,
- •Re-186 HEDP or Re-188-HEDP) within 3 months. Prior treatment with other
- •radiotherapeutic bone agents (e.g., Sr-89-chloride, P-32 -phosphate) within 6 months.
- •7.Receipt of any other investigational drug within 4 weeks of study entry.
- •8.Previous hemi-body external radiation therapy.
- •9.Receipt of external beam radiation for bone metastases with irradiation of bone
- •marrow more than 25%, within 6 months of study entry.
- •Related to the patient:
- •10.Known hypersensitivity to Re-188-HEDP or other phosphate compounds.
- •11.Patients whose medical history includes clinically significant bleeding disorders which
- •might be exacerbated by study medication.
- •12.Patients with concurrent illnesses or treatments that might preclude study completion
- •or interfere with study results.
- •13.Patients with active CNS (grade 2 or higher) or epidural brain metastasis.
- •14.Clinical diagnosis of disseminated intravascular coagulation
- •15.Absolute neutrophil count, ANC < 2 109/L.
- •16.Platelet count < 150 109/L.
- •17.Hemoglobin < 6 mmol/L.
- •18.Total PSA < 5 µg/L.
- •19.Serum creatinine clearance < 50 ml/min (Cockroft and Gault).
Investigators
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