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Clinical Trials/ACTRN12619000097145
ACTRN12619000097145
Recruiting
Phase 2

A phase II, open label study of durvalumab (medi4736) in combination with stereotactic body radiotherapy (sbrt) in androgen-intact patients with oligo metastatic prostate cancer measuring psa response

orthern Sydney Local Health District0 sites30 target enrollmentJanuary 23, 2019
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
orthern Sydney Local Health District
Enrollment
30
Status
Recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 23, 2019
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
Male

Investigators

Sponsor
orthern Sydney Local Health District

Eligibility Criteria

Inclusion Criteria

  • •adenocarcinoma prostate treated definitively with either radiotherapy or surgery
  • •disease free interval of \> 24mths from definitive management
  • •At least 5 half\-lives since any agent causing androgen deprivation and current Testosterone of \> 5nmol/L
  • •PSMA scan within 4 weeks of enrolment
  • •PSMA detected metastases either
  • •a.1\-3 and suitable for SBRT (Lymph node \&/or bone)
  • •b.\>3 but confined to pelvis and paraaortic regions

Exclusion Criteria

  • •\-•Any concurrent use of agents that reduce androgen production or block androgen action.
  • •\-•Active or prior documented significant autoimmune or inflammatory disorders
  • •\-•Current or prior use of immunosuppressive medication within 14 days before the first dose of study treatment.

Outcomes

Primary Outcomes

Not specified

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