New experimental treatment for early stage metastatic prostate cancer: The POPSTAR trial: Dr Farshad Foroudi

[JimJimJimJim]

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)

lisa.selbie@petermac.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.