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Optimal Prostate Study

NAACTIVE_NOT_RECRUITING

To compare the toxicity, rate of local control, biochemical failure rate and quality of life of three different radiotherapy techniques (moderate hypofractionation, stereotactic body radiotherapy (SBRT) and standard radiotherapy plus 2 fractions of SBRT (BOOSTER).

Study details:

Participants must have histologically proven prostate adenocarcinoma, good performance status and suitable for high dose radiotherapy. There are two groups of participants:. Group 1: eligible participants will be randomised to have either moderate hypofractionation or standard radiotherapy plus SBRT (BOOSTER).

Participants in this group must be able to have MRI, prostate fiducial markers (gold markers)and hydrogel insertion. Fiducial markers will be used to locate the prostate accurately during radiation treatment. Hydrogel is a temporary gel being injected into the space between the prostate and rectum to reduce the dose of radiation received by the rectum to minimise side effects from the treatment.

Group 2: eligible participants will be randomised to have either moderate hypofractionation or SBRT. Participants will be reviewed for side effects. A Safety Committee will be formed containing multi-disciplinary team members.

All serious adverse will be reported to the principal investigator and Human Research Ethics Committee within 24 hours.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Histologically proven prostate adenocarcinoma
  2. PSA obtained within three months prior to enrolment
  3. ECOG performance status 0 to 2
  4. Ability to understand and the willingness to sign a written consent
  5. Suitable for high dose irradiation to the prostate
  6. No contraindication to MRI such as pacemaker and severe claustrophobia
  7. Patient must be able to have fiducial markers placed in the prostate
  8. Patient must be able to have hydrogel insertion at the same time as fiducial markers
  9. Must have IPSS less than 15

Exclusion criteria

  1. Previous pelvic radiotherapy
  2. Prior total prostatectomy
  3. Unwilling or unable to give informed consent

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    NA

trial

Study ID

NCT03386045

Intervention or treatment

RADIATION: Optimal SBRT

RADIATION: Optimal Booster

Conditions

  • Prostate Cancer

  • Condition: Prostate Cancer

  • RADIATION: Optimal SBRT and other drugs

  • St Leonards, New South Wales, Australia

  • Sponsor: Royal North Shore Hospital

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Research sites nearby

Closest Location:

Royal North Shore Hospital

Select from list below to view details:

  • Royal North Shore Hospital

    St Leonards, New South Wales, Australia

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Who is running the clinical trial?

RNSH

Royal North Shore Hospital

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
ACTIVE_COMPARATOR: Optimal SBRT
  • Participants in this group will be randomised to either SBRT ( 36 to 45 GY in 5 fractions) or standard radiotherapy (60 Gy in 20 fractions). The allocation is 2 to 1. This means that two thirds of the participants on the trial will get the SBRT (5 treatments) and one third will get the standard fractions.
Radiation: Optimal SBRT
    ACTIVE_COMPARATOR: Optimal Booster
    • Participants in this group will be randomised to either standard radiotherapy plus SBRT (45 Gy in 20 fractions plus 20-30 Gy in 2 fractions-Booster) or standard radiotherapy (60 Gy in 20 fractions). The allocation is 2 to 1. This means that two thirds of the participants on the trial will get the Booster arm and one third will get the standard fractions.
    Radiation: Optimal Booster

      What is the study measuring?

      Primary Outcome

      MeasureDescriptionTime Frame
      local controlthe rate of local control as determined on PSMA scanning12 months post radiotherapy

      Secondary Outcome

      MeasureDescriptionTime Frame
      Biological failure rateThe rate of biochemical failure defined as Nadir+2.0 biochemical failure defined as Nadir+2.03 year and 5 year
      late toxicityLate Gastrointestinal and Genitourinary Toxicity (modified RTOG scale)more than three months after treatment completion.
      Markerless tracking technologyMarkerless tracking algorithms will be assessed for accuracy against marker-based localisation by masking the markers and directly comparing the determined trajectoriesDuring radiotherapy treatment
      Accuracy of the various intrafraction guidance methodsAccuracy of various intrafraction guidance methods will be determined against triangulation of kilovoltage (kV) and Megavoltage (MV) projectionsDuring radiotherapy treatment
      Are you running this trial?If you're a clinic or sponsor, you can claim this study.
      Claim this trial

      References

      Clinical Trials Gov: Optimal Prostate Study

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