Health TrialsbyHealthPanel

Focal Radiotherapy for Previously Treated Prostate Cancer Patients

ConditionLocally Recurrent Prostate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorRoyal North Shore Hospital

About this trial

To examine the feasibility, safety and toxicity of focal stereotactic radiation treatment (SBRT) for locally recurrent prostate cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men > 4yrs from external beam radiotherapy (EBRT) meeting the Phoenix definition of biochemical failure or men > 5yrs from EBRT if neo-adjuvant and/or adjuvant androgen deprivation therapy (ADT) also used

Recurrence localised to less than 1 lobe of prostate on both PMSA and multi-parametric MRI (less than equal to cT2a)

Recurrence must be biopsy proven, with positive biopsies limited to the PET and MRI suspicious region.

Life expectancy at least 10yrs from time of SBRT

Disqualifiers

Recurrence in immediate proximity to rectum (unless able to have hydrogel)

Grade 3 or more toxicity from previous EBRT

Contra-indicated for fiducial insertion

GS 8,9 or 10 disease previously (relative - consider if decent disease free interval)

Trial design

Design model

Sequential

Treatments tested in this trial

  • Stereotactic Body Radiotherapy

    Radiation

    Each group will have different dose of stereotactic body radiotherapy (SBRT). Depending on which group patients are in.

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: Group 1Other 1 intervention
Group B: Group 2Other 1 intervention
Group C: group 3Other 1 intervention

Trial outcomes

Primary outcomes

1

feasibility of SBRT dose escalation. This will be assessed by the number of participants with grade 3 acute toxicity according to CTCAE version 4.3

acute toxicity will be assessed weekly during treatment period to check whether dose escalation can be achieved

Time frame
at weekly review through completion of each radiothrapy dose level, approximately one year
2

safety of SBRT dose escalation. This will be assessed by the number of participants with grade 3 acute toxicity according to CTCAE version 4.3

outcome will be assessed by reviewing toxicity weekly during the treatment period and at the end of each dose escalation

Time frame
at weekly review through completion of each radiothrapy dose level, approximately one year
3

Toxicity. This will be assessed by the number of participants with grade 3 acute toxicity according to CTCAE version 4.3 and RTOG toxicity score.

outcome will be assessed by reviewing toxicity weekly and at the end of each dose escalation

Time frame
at weekly review through completion of each radiothrapy dose level, approximately one year

Secondary outcomes

1

Tolerability of conservation dose escalation in this cohort of patients

outcome will be assessed by reviewing toxicity weekly or secondly weekly and at the end of each dose escalation

Time frame
After each group of patients have completed radiotherapy and at 12 and 24 months follow-up. Patients will have routine follow-up 6 monthly for 1 year and then yearly for 10 years post treatment. But study outcomes will only be collected for 2 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Royal North Shore Hospital

Lead sponsor

Northern Sydney and Central Coast Area Health Service

Collaborator

Source ClinicalTrials.gov
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