A phase II study assessing whether biological markers can be used to determine response to treatment with radium-223 in patients with metastatic castration resistant prostate cancer (CRPC).

Phase 1

• Conditions: Castrate resistant prostate cancer with bone metastases.; Therapeutic area: Diseases [C] - Cancer [C04]; 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)

• Registration Number: EUCTR2013-004055-20-GB
• Lead Sponsor: The Royal Marsden NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-08
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 38

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.
8) Life expectancy = 6 months.
9) No prior chemotherapy for CRPC (adjuvant chemotherapy for hormone naïve disease is permissible).
10) Adequate laboratory requirements:
a.Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L
b.Platelet count greater than or equal to 100 x109/L
c.Haemoglobin greater than or equal to 10.0 g/dL (100 g/L; 6.2 mmol/L)
d.Total bilirubin level less than or equal to 1.5 institutional upper limit of normal (ULN)
e.ASAT and ALAT less than or equal to 2.5 x ULN
f.Creatinine less than or equal to 1.5 x ULN
g.Albumin greater than 30 g/L
11) Willing and able to comply with the protocol, including all assessments, scans, procedures, follow-up visits and examinations.
12) Must be fully informed about the study and has signed the informed consent form.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 19
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19

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.
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 clinical trial of medicinal product
• Study Design: Not specified