None listed
Conditions
Brief summary
Standard treatment for metastatic prostate cancer involves a course of Androgen Deprivation Therapy (ADT). ADT controls disease in about 95% of men for approximately 18 months, however, it can cause considerable side effects that decrease patients quality of life. Stereotactic Ablative Radiotherapy (SABR) has been shown to offer good cancer control rates of around 80% and progression-free survival at two to five years in the vicinity of 20-30% compared to standard RT, while offering the potential benefits of avoiding unpleasant symptoms that may arise from disease progression or side effects from ADT. In our institutions experience, SABR either as a first line therapy, or second line therapy in men who have progressed on hormone therapy, shows a substantial proportion of these patients responded very well, with some men not yet required hormone therapy or actually ceasing further hormone therapy. The TRANSFORM study is a single-institution, non-randomised, open-label, prospective phase II study that will recruit patients with radiologically confirmed hormone naïve or castration resistant oligometatstaic prostate cancer with the primary aim of measuring the proportion of patients not requiring treatment escalation at 5 and 10 years following SABR, respectively. The TRANSFORM study also aims to measure several secondary outcomesincluding time to treatment escalation, Prostate Specific Antigen (PSA) response, and grade 3 SABR related toxicities. Patients will be required to undergo a screening and follow up process (for up to ten years post treatment) that involves physical exams, blood and PSA tests, multiple scans (CT, MRI and PET) as well as questionnaires that help determine how effective the treatment(s) have been in controlling their disease and how that has impacted on their health and lifestyle.
Interventions
Enrolled patients will receive a course of stereotactic radiotherapy delivered five days a week over two weeks. The total dose of radiotherapy will be 50Gy in 10 fractions with 1 fraction delivered daily for 10 consecutive days (excluding weekends and public holidays). If there is overlap with previously delivered radiotherapy fields, an alternate fractionation schedule is acceptable given that an equivalent total dose in 2Gy fractions (EQD2) of at least 60Gy can be maintained.
Radiotherapy wi
Enrolled patients will receive a course of stereotactic radiotherapy delivered five days a week over two weeks. The total dose of radiotherapy will be 50Gy in 10 fractions with 1 fraction delivered daily for 10 consecutive days (excluding weekends and public holidays). If there is overlap with previously delivered radiotherapy fields, an alternate fractionation schedule is acceptable given that an equivalent total dose in 2Gy fractions (EQD2) of at least 60Gy can be maintained. Radiotherapy will be delivered by a radiation therapy team consisting of suitably qualified personnel and each treatment session will take approximately 10 minutes. The medical physics team is involved in planning prior to treatment to ensure accuracy of treatment delivery. A treatment delivery report will be produced and if any action level is exceeded, including significant internal organ variations or changes in the target volume that were not accommodated by prescribed treatment margins, the treatment plan will be redirected for immediate review and action by the appropriate staff.
Sponsors
Integrated Clinical Oncology Network Pty Ltd (ICON)
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
- Histologically confirmed diagnosis of prostate cancer. - Biochemical relapses of prostate cancer following radical local treatment. - Males aged 18 years to 80 years inclusive. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - N1 and M1 a/b disease on imaging, with a combined maximum of five synchronous lesions - Exclusion of local relapse. - Metastases suitable for ablative radiotherapy
Exclusion criteria
- No prior palliative radiotherapy (definitive radiotherapy as part of initial management is allowed). - Active local disease on clinical examination.
Outcome results
None listed