EUCTR2013-004055-20-GB
Active, not recruiting
Phase 1
A phase II randomised trial of biomarkers to assess (dose-) response in patients with metastatic castration resistant prostate cancer treated with radium-223. - REASURE (Radium-223: Evaluation of Activity and SUrrogate REsponse)
ConditionsCastrate resistant prostate cancer with bone metastases.MedDRA version: 21.1Level: PTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10005993Term: Bone metastasesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Castrate resistant prostate cancer with bone metastases.
- Sponsor
- The Royal Marsden NHS Foundation Trust
- Enrollment
- 38
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Histologically or cytologically confirmed adenocarcinoma of the prostate.
- •2\) Known castration resistant disease defined as:
- •\- Castrate serum testosterone level: \= 50 ng/dL (2\.0nM) and;
- •\- Bilateral orchidectomy or on maintenance androgen ablation therapy with LHRH agonist or polyestradiol phosphate throughout the study and;
- •\- Serum PSA progression defined by PCWG II criteria (i.e. two consecutive increases in PSA over a previous reference value, each measurement taken at least 1 week apart)
- •3\) Serum PSA value \= 2 ng/mL.
- •4\) Available ALP result from a blood sample taken within previous 8 weeks.
- •5\) Multiple skeletal metastases (\= 2 hot spots) on bone scintigraphy within previous 12 weeks.
- •6\) Age \=18 years.
- •7\) ECOG performance status 0\-2\.
Exclusion Criteria
- •1\) Any prior radioisotope therapy.
- •2\) Surgery, radiation, chemotherapy, or other anti\-cancer therapy within four weeks prior to randomisation into the study with the exception of LHRH agonists.
- •3\) Intention to commence cytotoxic chemotherapy within six months.
- •4\) Prior other malignancy within three years. Adequately treated basal cell or squamous cell skin or superficial (pTis, pTa, and pT1\) bladder cancer are allowed.
- •5\) Treatment with any investigational drug within 30 days prior to randomisation into the study.
- •6\) History of visceral metastasis, or visceral metastases, as assessed by chest/abdominal/pelvic CT within previous 8 weeks.
- •7\) Malignant lymphadenopathy exceeding 1\.5 cm in short\-axis diameter.
- •8\) Known brain or leptomeningeal involvement.
- •9\) Imminent/established spinal cord compression based on clinical findings/MRI (can be re\-screened following appropriate treatment).
- •10\) Blood transfusion or erythropoietin stimulating agents within the four weeks prior to randomisation.
Outcomes
Primary Outcomes
Not specified
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