JimJimJimJim Posted August 7, 2013 Share Posted August 7, 2013 Jim Marshall (not a doctor) said ... Following some success with other cancers, doctors are keen to investigate whether men with just a few prostate cancer metastases will respond to an aggressive treatment to the metastases while they are in an early stage. The researcher leading such a study, Dr Farshad Foroudi, will be our guest on our next phone-in meeting. He will explain the treatment of oligometastatic disease, the trial he leads (POPSTAR, details below), and planned trials. At least one of our members is involved in the trial at Sir Peter MacCallum Department of Oncology (PeterMac) in Melbourne. That meeting will be on Friday 23 August 2013, 9:30 am eastern states, 10:00 am Adelaide, 7:30 am Perth. ... end Jim Protocol Number: 12/162 Protocol: POPSTAR: A Pilot Sudy of patients with Oligometastases from Prostate cancer treated with Stereotactic Ablative Body Radiosurgery Sponsor: Peter MacCallum Cancer Centre Investigator: Dr Farshad Foroudi Study Coordinators: Lisa Selbie (9895 7528 Wed/Fri) / (9656 3626 Tue/Thurs) firstname.lastname@example.org Hypothesis The hypothesis is that stereotactic ablative body radiosurgery (SABR) is feasible and safe for patients with oligometastatic prostate cancer. Primary Objective ➘ To assess the feasibility and tolerability of SABR in prostate cancer patients with oligometastatic prostate cancer (up to 3 bone or lymph node metastases) Secondary Objectives ➘ to assess acute toxicity to estimate effectiveness of treatment to estimate the quality of life of patients before and after SABR to estimate the pain rating before and after SABR to determine changes in PSA following SABR Exploratory/Tertiary Objective ➘ To assess Na‐18F‐PET in patient selection and response assessment to SABR Inclusion Criteria ➘ Age 18 years or older ➘ Has provided written informed consent for participation in this trial ➘ Histological or cytologically confirmed prostate cancer ➘ Primary prostate cancer controlled (or planned to be) by surgery or radical radiotherapy ➘ Bone Scan or CT Scan evidence of 1 to 3 metastases (Bone or Lymph node) ➘ Androgen sensitive and castration‐resistant prostate cancer ➘ An ECOG performance status score of 2 or less ➘ Life expectancy greater than 12 months ➘ Available for follow up Exclusion Criteria ➘ Previous high dose radiotherapy (BED>40Gy) to the area to be treated ➘ Visceral Metastases (e.g. liver, lung or brain) ➘ Chemotherapy within +/‐ 3 weeks of SABR ➘ Any change in hormonal therapy regimen within 6 weeks prior to SABR ➘ Evidence of Spinal Cord Compression ➘ Lesion involving the skull ➘ Spinal Instability Neoplastic Score ≥ 7 unless lesion reviewed by a neurosurgical service and considered stable. ➘ Long bone Mirels score ≥ 7 unless reviewed by an orthopaedic service and considered stable ➘ Surgical fixation of lesion required for stability Treatment Plan Radiation Therapy Treatment 20Gy in 1 fraction delivered to each metastatic site Chemotherapy Treatment No concurrent chemotherapy will be administered within 3 weeks of planned SABR Other Drug Treatment Hormonal therapy provided it has been instituted at least 6 weeks before SABR will be allowed. Follow-up Schedule Patients will be followed up at 1 month post treatment, then 3 monthly thereafter for 2 years. Other Comments The following assessments must be done within 8 weeks prior to Registration: Confirmation of eligibility Disease site and staging investigations CT neck/chest/abdo/pelvis Whole body bone scan CT extremity (if lesion is on extremity) Medical History ECOG Physical examination Weight/height Haematology Urea/creatinine PSA/Testosterone Spinal Instability Score &/or Mirels score if applicable The following assessments must be done within 2 weeks prior to SABR: Quality of Life Questionnaires Numerical Pain Rating Score Adverse event/toxicity Assessment Na-F18 PET scan RECIST measurements to be recorded All patients should receive their SABR treatment within 8 weeks of Registration This may not be the latest version. Please refer to full current approved version of protocol for more information. Link to comment Share on other sites More sharing options...
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