Radium-223: evaluation of activity and surrogate response

Phase 2

Completed

• Conditions: Prostate cancer; Cancer

• Registration Number: ISRCTN17805587
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

2021 Results article in https://doi.org/10.1016/j.clgc.2021.03.020 Fracture risk (added 07/05/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37788117/ Disease response in bone (added 04/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-21
• Study Completion: 2018-12-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

1. Histologically or cytologically confirmed adenocarcinoma of the prostate.
2. Known castration resistant disease defined as:
2.1. Castrate serum testosterone level: = 50 ng/dL (2.0nM)
2.2. Bilateral orchidectomy or on maintenance androgen ablation therapy with LHRH agonist or polyestradiol phosphate throughout the study
2.3. 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 =16 years
7. ECOG performance status 0-2.
8. Life expectancy = 6 months.
9. No prior chemotherapy for CRPC (adjuvant chemotherapy for hormone naïve disease is permissible).
10. Adequate laboratory requirements:
10.1.Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L
10.2. Platelet count greater than or equal to 100 x109/L
10.3. Haemoglobin greater than or equal to 10.0 g/dL (100 g/L; 6.2 mmol/L)
10.4. Total bilirubin level less than or equal to 1.5 institutional upper limit of normal (ULN)
10.5. ASAT and ALAT less than or equal to 2.5 x ULN
10.6. Creatinine less than or equal to 1.5 x ULN
10.7. Albumin greater than 30 g/L
11. Willing and able to comply with the protocol, including all assessments, scans, procedures, followup visits and examinations
12. Must be fully informed about the study and has signed the informed consent form

Exclusion Criteria

1. Any prior radioisotope therapy
2. Surgery, radiation, chemotherapy, or other anticancer 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
11. Faecal incontinence
12. Unsuitable for MRI (patient refusal or clinical contra-indication)
13. Inadequate organ or bone marrow function
14. Any other serious illness or medical condition

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients showing bone metastases response on diffusion weighted MRI (DW-MRI). From pre-treatment to any point after 1st injection and the end of cycle 6 will be used to define response.