None listed
Conditions
Brief summary
The purpose of this study is to test the effectiveness of a medication called Durvalumab in combination with radiotherapy for prostate cancer. Who is it for? You may be eligible for this study if you are aged 18 or over and have prostate cancer and are not currently taking treatments that block male hormones. Study details All participants in this study will take Durvalumab every 4 weeks for a year. The medication is given through a needle in the arm. Additionally, participants will undergo radiotherapy one month after starting the Durvalumab. As part of this study, participants will undergo blood tests and answer questionnaires. It is hoped this research will contribute to the care of prostate cancer patients by treating the disease without the use of hormone blocking drugs.
Interventions
Durvalumab fixed dose 1500mg intravenously every 4 weeks for one year. Durvalumab will be administered in the Day Therapy Unit under direct observation by study personnel
Radiotherapy to metastases given one month after first dose of Durvalumab. Radiotherapy doses will be 30 Gray in 3 fractions to gross lymph nodes two treatmetns per week or 55 Gray in 20 fractions to gross lymph nodes and 45 Gray in 20 fractions (all fractions given daily Monday to Friday) to at risk draining lymph nodesor Ster
Durvalumab fixed dose 1500mg intravenously every 4 weeks for one year. Durvalumab will be administered in the Day Therapy Unit under direct observation by study personnel Radiotherapy to metastases given one month after first dose of Durvalumab. Radiotherapy doses will be 30 Gray in 3 fractions to gross lymph nodes two treatmetns per week or 55 Gray in 20 fractions to gross lymph nodes and 45 Gray in 20 fractions (all fractions given daily Monday to Friday) to at risk draining lymph nodesor Stereotactic Body Radiotherapy 24 Gray in two fractions given over one week
Sponsors
Northern Sydney Local Health District
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed