Combined radiotherapy and immunotherapy for men with early metastatic prostate cancer not on hormone therapy
Phase 2
Recruiting
- Conditions
- Prostate CancerCancer - Prostate
- Registration Number
- ACTRN12619000097145
- Lead Sponsor
- orthern Sydney Local Health District
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PSA progression free survival defined as time to post treatment nadir PSA + 0.2 ug/L. PSA will be assessed by monthly blood tests.[12 months post enrollment];Toxicity as assessed by CTCAE version 4 criteria [12 months post enrollment]
- Secondary Outcome Measures
Name Time Method Biochemical (PSA) response rate as assessed by serum PSA measurements[12 months post enrollment]