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Prostate adenocarcinoma adjuvant EBRT post radical prostatectomy

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  • Post radical prostatectomy for adenocarcinoma prostate
  • One or more of the following adverse pathological features:
    • extraprostatic extension (pT3a, pT4)
    • seminal vesicle invasion (pT3b)
    • positive resection margins
  • No evidence of lymph node (N0) or distant metastases (M0)
  • ECOG 0 - 2
  • RT ideally within 4 to 6 months of radical prostatectomy

Cautions

  • Pacemakers and Implantable Cardioverter Defibrillators (ICDs)
  • Non-rheumatoid collagen vascular disorders
  • Inflammatory bowel disease and/or history of adhesions/bowel obstruction
  • Bilateral hip replacement (associated with increased rectal toxicity)rr

Exclusions

  • Prior high dose radiation to the pelvis
  • Link to MSK nomogram – Post Radical Prostatectomy
  • To allow for maximal recovery of continence prior to radiotherapy, consider delayed RT start date ensuring commencement of treatment is within 4 to 6 months of surgery.
  • Pelvic floor exercises may be helpful - consider referral to continence nurse or physiotherapist.
Simulation Options Notes
Position
  • Supine
  
Arm/leg/head/neck/shoulder position
  • Arms on chest
  
Immobilisation and supports
  • Neck support
  • Knee supports
  • Ankle stocks
  • Vacbag (optional)
  
Organ pre-requisites
  • Bladder full
  • Rectum empty
 Bladder and rectal filling should be consistent between CT simulation and daily treatment delivery.
Contrast
  • Optional IV or bladder contrast
 Consider planning CT scan with IV contrast to assist with localising the urethro-vesicle anastomosis and delineation of the CTV.
Link to Management and guidelines for the use of IV contrast for radiotherapy planning.
Radio-opaque markers
  • Fiducial markers (optional)
  
Bolus
  • N/A
  
Other imaging
  • MRI
 Consider MRI to assist with the delineation of the CTV.
CT acquisition
  • 3DCT
 Scan from L3/L4 to 1.5cm below the ischial tuberosities.
Medications
  • N/A
  
3DCRT/IMRT/VMAT
Phase Target area Dose prescription Prescription point/ volume Beam type Beam Energy Dose/# Fractions Scheduling
#/day #/fortnight
1 Prostate bed 60 - 68Gy ICRU 50/62/83 Photons 6 - 18MV 1.8 - 2Gy 30 - 34 1 9 - 10
1 Elective Nodes (optional)** 50 - 56Gy ICRU 83 (IMRT/VMAT) Photons 6 - 18MV 1.8 - 2Gy 30 - 34 1 9 - 10

Prescription notes

  • **Elective nodal irradiation is optional and can be considered in selected high risk patients.
  • If gross disease apparent, consider to boost gross disease up to 74 Gy.

For PTV and CTV target volumes, see link to Table 6 in the FROGG​ Consensus guidelinesr

Margin ranges have been agreed by the Radiation Oncology reference committee and reflect safe clinical practice

Organ Constraints Additional information
Rectum The recommended volume irradiated should not exceed the following constraints:
  • ​V40Gy < 60% (ideally < 35%)r
  • V65Gy < 40% (ideally < 17%)
  • V70Gy < 30%
  • V75Gy < 10%
 The following rectal DVHs are largely based on voluming the rectum as follows:
  • The outer wall of the rectum is contoured superiorly from the recto-sigmoid junction (where the rectum turns horizontally into the sigmoid, usually at the caudal border of the sacro-iliac joint) to 1.5cm caudal to the inferior border of the CTV (prostate apex). Superiorly, the anorectal contours should extend at least 0.5 cm beyond the proximal margin of the PTV.
  • If unable to achieve rectal dose constraints, consider a 2 phase technique treating the above CTV (region at risk of low burden of microscopic disease) to 50 Gy and boost the high risk volume (site of positive margin/s or extra-capsular extension).
  • If still unable to meet rectal dose constraints reduce the posterior PTV margin expansion to 5 mm for the entire treatment.
Bladder The recommended volume irradiated should not exceed the following constraints:
  • 50% < 50Gyr
  • The whole of the external wall of the bladder should be contoured to the slice above the anastomosis.
  • If unable to meet this dose constraint suggest reviewing bladder filling.
  • PTV coverage should not be compromised to achieve this dose constraint.
Femoral heads
  • V35Gy < 100%
  • V45Gy < 60%
  • V60Gy < 30%
 The femoral head is defined from the acetabulum to the inferior edge of the treatment field.
Small bowel 2cc < 60Gy
100cc < 45Gy (cavity)

QUANTEC:r (Loops): V15 < 120cc and (Peritoneal Cavity) V45 < 195 cc

 Any small bowel loops which fall into the treatment field (or within 2 cm of the PTV) should be contoured.
Be aware of the location of small bowel when determining volumes. Avoid dosimetric hotspots in loops of the small bowel. Small bowel should be contoured within the PTV.
Large bowel There are no clear guidelines however departments may choose to use the constraints for rectum or small bowel for large bowel.  
Modality Frequency Match point
  • kV or
  • MV or
  • Cone beam CT
  • Daily
  • Bone
  • Soft tissue

Target verification recommendations reflect the minimum imaging required for the safe delivery of this protocol and should be considered in relation to CTV-PTV margin expansion.

Target verification notes

  • Consideration should be given to dose delivered from verification imaging and whether this needs to be accounted for in treatment planning, particularly with respect to critical OARs.

The side effects listed below are not a complete list of all possible side effects for this treatment and should only be used as a guide.

Acute: Short term side effects during or within a few weeks post radiotherapy (usually temporary)
Fatigue

Read more about fatigue
Irritative or obstructive urinary symptoms

Bladder spasms, dysuria, nocturia, frequency, incontinence, urgency, retention.
Cystitis

Read more about cystitis
Proctitis

Including diarrhoea, increased bowel frequency, rectal urgency, pain and bleeding.

Read more about Proctitis
Incontinence

Rare.

Late: Long term side effects - months post radiotherapy (may be permanent)
Sexual dysfunction - male

Including erectile dysfunction, impotence, dry/painful ejaculation, orgasmalgia. Patients should be offered sexual counselling to manage the potential late radiotherapy toxicities on sexual function.
Proctitis

Read more about proctitis
Urethral stricture
Cystitis/urethritis
Bone injury
Second malignancy
Source Study & year published Supports use
Yes/No/NA		 Is the radiation dose and fractionation consistent with the protocol? Comments
Meta-analysis Daly et al, 2011r Yes Yes  
Phase III trials Bolla et al, 2005r and 2012r Yes Yes  
Wiegel et al, 2014r Yes Yes  
Thompson et al, 2006r and 2009r Yes Yes  
Guidelines Date published/revised Supports use
Yes/No/NA		 Is the dose and regimen consistent with the protocol? Comments
NCCN V3, 2016r Yes Yes 64 - 72 Gy  
FROGG consensus guidelines 2008r Yes Yes  
ASTRO/AUA 2013r Yes Yes  

Efficacy

The evidence supporting this protocol is provided by three RCT’s comparing Post operative RT or a wait and see policy after radical prostatectomy.

In the EORTC trial 22911 between 1992 and 2001, Bolla et alr randomly assigned men to post-operative irradiation (RT, n=502) or observation/wait and see policy (WS, n=503). After a median follow up of 10.6 years, post-operative RT significantly improved biochemical PFS where 39.4% of the RT group had biochemical or clinical progression or died compared with 61.8% in the WS group [HR 0.49; CI p<0.0001]. Locoregional control was significantly better with RT than with WS group (HR 0.45 p<0.0001) and the 10 year cumulative rate of locoregional relapse was 16.6% vs 7.3% in the RT vs WS groups respectively.

The SWOG 8794 trialr also reported significant improvements in the median PSA relapse free survival of 10.3 years vs 3.1 years for RT and observation respectively (HR 0.43 p<0.001) after a median follow up of 10.6 years. Median disease recurrence free survival 13.8 years for RT vs 9.9 years for observation (HR 0.62; p<0.001). While there was a trend to improved metastasis free survival, this was not statistically significant.

At the 10 year follow up, the ARO 96-02 trialr patients were randomised to Adjuvant RT of 60Gy/30# (n=148) compared with a wait and see policy (n=159). Superior PFS outcomes for Adjuvant RT (56%) vs a wait and see policy (35%) p<0.0001 were demonstrated. Overall survival and metastases free survival was not significant improved by Adjuvant RT.

Currently the RAVES trial (TROG 08.03),r a phase III multicentre randomised trial is underway (accrual closed late 2015) comparing adjuvant radiotherapy (RT) with early salvage RT in patients with positive margins or extraprostatic disease following RP.

Biochemical progression free survival

Bolla et al 2012r

Toxicity

A summary of the most clinically significant toxicities associated with this protocol are included in the table below:

Toxicity Study/Year Incidence of event or % Comment
Early
Rectal complications e.g. proctitis/rectal bleeding Thompson et al, 2006r RT: 3.3%
Obs: 0%		 ART n= 214
Obs n= 211
Urethral stricture RT: 17.8%
Obs: 9.5%
Total urinary incontinence RT: 6.5%
Obs: 2.8%
Late
Any Grade 3 toxicity Bolla et al, 2005r RT: 4.2%
Obs: 2.6%		 5 year follow up
Grade 3 bladder Wiegal et al, 2014r RT: 3%
Obs: 0%

N= 159 (obs)
N= 148-ART
10 year follow up
Grade 4 bladder RT- 0%
Obs- 0%
Stricture RT:3%
Obs:1%
Grade 3 GI tract 0%
Grade 4 GI tract 0%
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Version 5

Date Summary of changes
28/07/2008

Previous CI-SCaT ID : 02-1161
Link to the "Post-prostatectomy radiation therapy: Consensus guidelines of the Australian and New Zealand Radiation Oncology Genito-Urinary Group" added.
20/08/2009 Reviewed and transferred to eviQ
2/12/2011

Biennial review (Dec 2011) and updated with the following changes:

Summary table 

  • Concurrent treatment - Androgen suppression statement added

Patient Population

  • amended to include the exclusion statement -  "Patients with PSA > 0.1ng/mL may be treated with salvage protocol. Click here for a link to the Post Prostatectomy Salvage protocol"

Dose Prescription

  • IMRT reporting requirements added

Efficacy

  • updated with long term results from EORTC 22911 trial - Bolla 2005 and the SWOG 8794 results Thompson 2009

Toxicity

  • updated with EORTC results

Review group 2
30/04/2017

Full protocol review at August 2016 RCM

Approved and published to eviQ

Review group 2
31/05/2017 Transferred to new eviQ website.

The information contained in this protocol is based on the highest level of available evidence and consensus of the eviQ reference committee regarding their views of currently accepted approaches to treatment. Any clinician (medical oncologist, haematologist, radiation oncologist, medical physicist, radiation therapist, pharmacist or nurse) seeking to apply or consult this protocol is expected to use independent clinical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use is subject to eviQ’s disclaimer available at www.eviQ.org.au

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https://www.eviq.org.au/p/304

22 Apr 2019