None listed
Conditions
Brief summary
This study assesses the usefulness of Choline and Fluro-deoxy-glucose PET scans in determining treatment for men with high risk prostate cancer planned for radical radiotherapy Who is it for? You can join this study if you are a man with high risk prostate cancer and treatment with radical radiotherapy is planned. Trial details A total of 30 participants will all undergo PET scans with radioactive markers Fluro-deoxy-glucose (FDG) and Choline (C) to evaluate whether these diagnostic tools can be used to improve planning for radiotherapy treatment. Results of the scans will be compared with standard imaging technologies (CT and MRI) to see if they provide additional information that can improve treatment. Participants undergo androgen deprivation therapy (hormone therapy) for 3 years. During this period participants also undergo normal radiotherapy treatments. Patients are monitered for 2 years after the completion of radiotherapy to assess the usefulness of the PET scans.
Interventions
30 non randomised patients with prostate cancer undergo baseline/staging assessments. This include blood analysis for prostate specific antigen (PSA) levels, 1xcomputed tomography (CT), 1xmagnetic resonance imaging (MRI), 1xbone scan, 1xFDG and 1xC PET scan, with a 24 hour time lapse betweeen the 2 PET scans. Patients then commence androgen deprivation therapy for 3 years. This involves Eligard injections (dose:22.5mg) every 3 months. 3 months into hormone therapy, patients undergo their 2nd se
30 non randomised patients with prostate cancer undergo baseline/staging assessments. This include blood analysis for prostate specific antigen (PSA) levels, 1xcomputed tomography (CT), 1xmagnetic resonance imaging (MRI), 1xbone scan, 1xFDG and 1xC PET scan, with a 24 hour time lapse betweeen the 2 PET scans. Patients then commence androgen deprivation therapy for 3 years. This involves Eligard injections (dose:22.5mg) every 3 months. 3 months into hormone therapy, patients undergo their 2nd set of assessments to evaluate initial hormone response and for planning radiotherapy treatment. This involves 1xCT, 1xMRI, 1xFDG and 1x C PET scan, with a 24 hour time lapse between the 2 PET scans. Patients undergo normal radiotherapy treatments for 8weeks, 5 days/week. About 9 months into hormone therapy (and 4 months after radiotherapy), patients undergo their 3rd set of assessments involving 1xCT, 1xMRI, 1xFDG and 1xC scan, with 24 hour time lapse between the 2 PET scans. The 4th and final set of assessments are conducted at the end of study, that is 5 years after commencement into study (ie 2 years after completing their hormone therapy). This involve blood analysis for PSA levels, 1x CT, 1xMRI, 1xFDG and 1xC scan, with a 24 hour time lapse between the 2 PET scans
Sponsors
Austin Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
PSA > 20 or Gleason score 8-10 or T stage T3a,T3b or T4 Age > 18 years Eastern Cooperative Oncology Group Performance Status (ECOG) 0 or 1 No significant medical or psychiatric illness Written informed consent Be prepared to undergo PET scanning
Exclusion criteria
Any form of prostate malignancy T1-2c prostate cancer and PSA , 10 and Gleason score < 7 Previous radical prostatectomy Known metastatic prostate cancer Contraindication to MRI Contraindication to androgen ablation Contraindication to PET Commencement of androgen depriavation therapy prior to study entry Previous pelvic radiotherapy Contraindication to radiotherapy
Outcome results
None listed