Overview

Trial of Rad-223 Activity in Asymptomatic Patients With mCRPC While on Abiraterone or Enzalutamide Besides AR-V7 Status

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
Summary
Radium-223 is indicated for the treatment of patients with mCRPC with symptomatic bone metastases and no known visceral metastatic disease. However, very few data have been reported in patients with mCRPC who are asymptomatic or mildly symptomatic. Recently, results from an International Expanded Access Program have also suggested a benefit of radium-223 in asymptomatic patients with mCRPC. In addition, the mechanism of action of radium-223 should not be correlated with the presence/absence of the AR-V7 mutation, although this issue has not yet been evaluated. The aim of this study is to assess the efficacy of radium-223 in asymptomatic patients with mCRPC, and to establish the association between AR-V7 status and radium-223 activity.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
MedSIR
Collaborator:
Bayer
Treatments:
Abiraterone Acetate
Criteria
Inclusion Criteria:

- Subject is an adult ≥ 18 years at the time of informed consent and has signed informed
consent before any trial related activities and according to local guidelines.

- Subject has histologically confirmed adenocarcinoma of the prostate without
neuroendocrine differentiation or small cell features.

- Subject has bone metastases due to the prostate cancer and absence of visceral
metastases.

- Subject has a serum testosterone of ≤ 1.7 nmol/L (or ≤ 50 ng/dL) at screening.

- Subject must have received a minimum of 24 weeks of treatment with abiraterone acetate
or enzalutamide within its approved label indication and has discontinued use at least
four weeks prior to start of study drug at day 1.

- Prior use of docetaxel is allowed in castration-naïve patients (maximum of six
cycles).

- Subject receives and will continue to receive ongoing androgen deprivation with LHRH
analogue therapy throughout the course of the study or has had a bilateral
orchiectomy.

- Subject is asymptomatic from prostate cancer, defined as patients with the score on
brief pain inventory (short form) (BPI-SF) Question #3 must zero and no use of opiate
analgesics for prostate cancer-related pain currently or anytime within two weeks
prior to screening.

- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at
screening.

- Subject receiving bisphosphonate or other approved bone-targeting therapy must have
been on stable doses for at least four weeks prior to start of study drug at day 1.

- Subject has a life expectancy of more than or equal to 12 months.

- Subject agrees not to participate in another interventional study while on study drug.

- Subject and his female partner who is of childbearing potential must use two
acceptable methods of birth control (one of which must include a condom as a barrier
method of contraception) starting at screening and continuing throughout the study
period and for six months after final study drug administration.

Exclusion Criteria:

- Subject has received any anti-neoplastic therapy (including ketokonazol and
chemotherapy) following abiraterone acetate or enzalutamide discontinuation and prior
to start of study drug at day 1.

- Subject has known or suspected brain metastases or active leptomeningeal disease.

- Subject has concurrent disease or any clinically significant abnormality following the
investigator's review of the physical examination and safety laboratory tests at
screening, which in the judgment of the investigator would interfere with the
subject's participation in this study or evaluation of study results.

- Subject has a history of another invasive cancer within three years prior to
screening, with the exceptions of non-melanoma skin cancers or a non-infiltrating
muscle bladder cancer that have a remote probability of recurrence in the opinion of
the investigator in consultation with the medical monitor.

- Subject had major surgery within one month prior to screening.

- Subject has received investigational therapy within 28 days or 5 half lives, whichever
is longer, prior to start of study drug at day 1.

- Subject has absolute neutrophil count < 1,500/μL, platelet count < 100,000/μL, and
hemoglobin < 6.25 mmol/L (or < 10 g/dL) at screening (Note: Subjects must not have
received any growth factors or blood transfusions within seven days of the hematologic
laboratory values obtained at screening).

- Subject has total bilirubin > 1.5 times the upper limit of normal (ULN) at screening,
except for subjects with documented Gilbert's syndrome.

- Subject has creatinine > 2.5 mg/dL at screening.

- Subject has albumin ≤ 30 g/L (or ≤ 3.0 g/dL) at screening.