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NCT Number: NCT03386045

Optimal Prostate Study

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically proven prostate adenocarcinoma
  • PSA obtained within three months prior to enrolment
  • ECOG performance status 0 to 2
  • Ability to understand and the willingness to sign a written consent
  • Suitable for high dose irradiation to the prostate

To be eligible for the arm containing Stereotactic Booster alone approach patient must have the following

  • No contraindication to MRI such as pacemaker and severe claustrophobia
  • Patient must be able to have fiducial markers placed in the prostate
  • Patient must be able to have hydrogel insertion at the same time as fiducial markers
  • Must have IPSS less than 15

Exclusion criteria

  • Previous pelvic radiotherapy
  • Prior total prostatectomy
  • Unwilling or unable to give informed consent

Treatment and study plan

Optimal SBRT

Radiation

Two thirds of the participants in this group will get the SBRT (5 treatments) and one third will get standard treatment (60 Gy in 20 treatments)

Optimal Booster

Radiation

Two thirds of the participants in this group will get the two high precision radiotherapy plus 20 doses of standard external beam radiotherapy (ie the "Booster approach|") and one third will get the standard treatment (60 Gy in 20 treatments)

Primary outcomes

  1. local control

    Time frame: 12 months post radiotherapy

    the rate of local control as determined on PSMA scanning

Secondary outcomes

  1. Biological failure rate

    Time frame: 3 year and 5 year

    The rate of biochemical failure defined as Nadir+2.0 biochemical failure defined as Nadir+2.0

  2. late toxicity

    Time frame: more than three months after treatment completion.

    Late Gastrointestinal and Genitourinary Toxicity (modified RTOG scale)

  3. Markerless tracking technology

    Time frame: During radiotherapy treatment

    Markerless tracking algorithms will be assessed for accuracy against marker-based localisation by masking the markers and directly comparing the determined trajectories

  4. Accuracy of the various intrafraction guidance methods

    Time frame: During radiotherapy treatment

    Accuracy of various intrafraction guidance methods will be determined against triangulation of kilovoltage (kV) and Megavoltage (MV) projections

Sponsors and collaborators

Lead sponsor

Royal North Shore Hospital

Other

Registry information

Official study title

Optimal Prostate Fractionation Study

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Dec 29, 2017
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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