The PRECISION Study: 3 Fractions of Prostate SBRT and RayPilot HypoCath Image Guidance

ConditionsLocalized Prostate Cancer Low Risk Prostate Cancer Intermediate Risk Prostate Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexMale

AgeNot listed

SponsorNHS Lothian

About this trial

The investigators want to investigate whether it is possible to reduce the number of curative radiotherapy doses from 5 to only 3 for men with localized early prostate cancer. The aim of the study is to ensure that the side effects of the 3-dose treatment are the same or potentially lower than those already published when using the 5-dose treatment as used in the UK PACE-B trial (NCT01584258). The name of this type of radiotherapy is Stereotactic Body Radiotherapy (SBRT) or participants may see it referred to as Stereotactic Ablative Radiotherapy (SABR). The study is a two-stage single arm Phase II study open to those Centres that use the RayPilot HypoCath tumour tracking system (Micropos Medical). This commercially available system was not available at the time of the original PACE-B study. The system acts like a Global Positioning Device (GPS) to continuously track the prostate position during radiotherapy. If the prostate moves more than 2mm (about 0.08 in) from its intended position during the treatment, then the radiotherapy team are alerted, and the treatment halted until the prostate moves back into the correct position. The ability to understand exactly where the prostate is throughout the treatment ensures the intended dose hits the cancer and does not accidentally increase the dose to the nearby bladder and rectum. The system is a modification of a standard urinary catheter which sits within the bladder with the GPS placed within the wall of the catheter as it passes through the prostate. The investigators are not testing the system as it is commercially available but using it to improve the accuracy of radiotherapy delivery, reducing the number of days of treatment, minimizing side effects and helping ease the burden on busy radiotherapy Departments.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

low and favorable intermediate NCCN Criteria patients

Prostate volume under 80cc

IPSS under 20

Q-max above 10cc per second and urinary residual less than 150mls

Disqualifiers

T3a or above

Gleason 4+3=7

PSA>20ng/ml

Trial design

Design model

Single group

Treatments tested in this trial

3 fractions of prostate SBRT
Radiation
Radical radiotherapy using only 3 fractions of prostate SBRT over 3 consecutive days

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: 3 fractions of prostate Stereotactic Body Radiotherapy (SBRT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

The number of patients with acute Radiation Oncology/ Toxicity Grading (RTOG) urinary toxicity

Clinician reported cumulative Grade 2 or worse RTOG acute GU toxicity from baseline up to 12 weeks post treatment (scale 0-4 with 0 being none increasing severity to grade 4).

Time frame

At 12 weeks post completion of treatment

The number of patients with acute Common Terminology for Adverse Events (CTCAE) urinary toxicity

Clinician reported cumulative Grade 2 or worse CTCAE v5.0 acute GU toxicity from baseline up to 12 weeks post treatment (scale 0-5 with increasing severity to death at grade 5)

Time frame

At 12 weeks post completion of treatment

The number of patients with acute Radiation Oncology/ Toxicity Grading (RTOG) bowel toxicity

Clinician reported cumulative Grade 2 or worse RTOG acute GI toxicity from baseline up to 12 weeks post treatment (scale 0-4 with 0 being none increasing severity to grade 4).

Time frame

At 12 weeks post treatment

The number of patients with acute Common Terminology for Adverse Events (CTCAE) bowel toxicity

Clinician reported cumulative Grade 2 or worse CTCAE v5.0 acute GI toxicity from baseline up to 12 weeks post treatment (scale 0-5 with increasing severity to death at grade 5).

Time frame

At 12 weeks

Secondary outcomes

The number of patients with late Radiation Oncology/ Toxicity Grading (RTOG) urinary toxicity

Clinician reported Grade 2 or worse RTOG late GU toxicity at 24 months (scale 0-4 with 0 being none increasing severity to grade 4).

Time frame

At 24 months post completion of radiotherapy treatment

The number of patients with late Common Terminology for Adverse Events (CTCAE) urinary toxicity

Clinician reported Grade 2 or worse CTCAE v5.0 late GU toxicity at 24 months (scale 0-5 with increasing severity to death at grade 5).

Time frame

At 24 months post completion of radiotherapy treatment

The number of patients with late Radiation Oncology/ Toxicity Grading (RTOG) bowel toxicity

Clinician reported Grade 2 or worse RTOG late GI toxicity at 24 months (scale 0-4 with 0 being none increasing severity to grade 4).

Time frame

At 24 months post completion of radiotherapy treatment

The number of patients with late Common Terminology for Adverse Events (CTCAE) bowel toxicity

Clinician reported Grade 2 or worse CTCAE v5.0 late GI toxicity at 24 months (scale 0-5 with increasing severity to death at grade 5).

Time frame

At 24 months post completion of radiotherapy treatment

Other outcomes

Urethral dose sparing and acute Radiation Oncology/ Toxicity Grading (RTOG)

HypoCath Image Guidance with RayPilot and urethral dose sparing will result in lower grade 2+ RTOG GU acute toxicity than reported in the PACE-B trial when using a standard Linear accelerator

Time frame

To be assessed at week 12 and month 24 post completion of treatment

Urethral dose sparing and acute Common Terminology for Adverse Events (CTCAE)

HypoCath Image Guidance with RayPilot and urethral dose sparing will result in lower grade 2+ CTCAE v5.0 GU acute toxicity than reported in the PACE-B trial when using a standard Linear accelerator

Time frame

To be assessed at week 12 and month 24 post completion of treatment

Urethral dose sparing late Radiation Oncology/ Toxicity Grading (RTOG)

HypoCath Image Guidance with RayPilot and urethral dose sparing will result in lower grade 2+ RTOG GU late toxicity than reported in the PACE-B trial when using a standard Linear accelerator

Time frame

To be assessed at week 12 and month 24 post completion of treatment

Urethral dose sparing late Common Terminology for Adverse Events ( CTCAE

HypoCath Image Guidance with RayPilot and urethral dose sparing will result in lower grade 2+ CTCAE v5.0 GU late toxicity than reported in the PACE-B trial when using a standard Linear accelerator

Time frame

To be assessed at week 12 and month 24 post completion of treatment

Sponsors and contacts

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

NHS Lothian

Lead sponsor

Source ClinicalTrials.gov

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