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Optimal Prostate Study

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).

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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.

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Eligibility criteria

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

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

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: Male

Things to know

Study dates

Study start: 2018-10-02

Primary completion: 2028-08-01

Study completion finish: 2028-08-01

Study type

TREATMENT

Phase

Trial 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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Find a site

Closest Location:

Royal North Shore Hospital

Research sites nearby

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Royal North Shore Hospital
St Leonards, New South Wales, Australia

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/Arm	Intervention/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 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)
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 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)

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
local control	the rate of local control as determined on PSMA scanning	12 months post radiotherapy

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Biological failure rate	The rate of biochemical failure defined as Nadir+2.0 biochemical failure defined as Nadir+2.0	3 year and 5 year
late toxicity	Late Gastrointestinal and Genitourinary Toxicity (modified RTOG scale)	more than three months after treatment completion.
Markerless tracking technology	Markerless tracking algorithms will be assessed for accuracy against marker-based localisation by masking the markers and directly comparing the determined trajectories	During radiotherapy treatment
Accuracy of the various intrafraction guidance methods	Accuracy of various intrafraction guidance methods will be determined against triangulation of kilovoltage (kV) and Megavoltage (MV) projections	During radiotherapy treatment

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References

Clinical Trials Gov: Optimal Prostate Study