Radiotherapy - Adjuvant Versus Early Salvage

Prostate Cancer Clinical Trial

— RAVES  

Official title:

Radiotherapy - Adjuvant Versus Early Salvage. A Phase III Multi-centre Randomised Trial Comparing Adjuvant Radiotherapy (RT) With Early Salvage RT in Patients With Positive Margins or Extraprostatic Disease Following Radical Prostatectomy.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00860652
• Other study ID #: TROG 08.03
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 3, 2009
• Est. completion date: December 2026

Study information

• Verified date: November 2022
• Source: Trans Tasman Radiation Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Radical prostatectomy (RP) is the most common curative approach offered to men with newly diagnosed prostate cancer. Unfortunately, up to half of these patients will have factors placing them at high risk of their cancer recurring. Having radiotherapy after RP is known to improve cure rates, but what is not known is whether it should be given straight after the operation or only when there is a rising PSA after surgery indicating active cancer. Immediate RT may not benefit all men, and can cause serious side effects such as bladder and bowel problems and impotence. International lack of consensus on the optimal timing of RT has resulted in varied clinical practice. This phase 3 trial will compare the two approaches.

Description:

This is a prospective, multi-centre, international, randomised controlled trial with a 1:1 allocation ratio. Patients with positive margins and/or pT3 disease will be randomised to adjuvant RT (Standard Arm) or active surveillance with salvage RT delivered at early relapse (Experimental Arm). 64 Gy in 32 fractions will be delivered to the prostate bed. QoL self-assessment questionnaires, Hospital Anxiety and Depression Score and toxicity will be assessed at baseline, the end of RT and annually for 5 years. Patients will be seen by their doctor 6 monthly for the first 5 years, then annually for the next 5 years. A blood test measuring prostate specific antigen (PSA) is done 3 monthly for the first 5 years for patients randomised to early salvage RT, then 6 monthly from years 5 to 10.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 333
• Est. completion date: December 2026
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prior Radical Prostatectomy (RP) for adenocarcinoma of the prostate.
• Histological confirmation of adenocarcinoma of the prostate with the Gleason score reported (Radical Prostatectomy specimen).
• Patients must have at least one of the following risk factors: 1) Positive margins, 2) Extraprostatic extension (EPE) with or without seminal vesicle involvement (pT3a or pT3b)
• Capable of starting RT within 4 months of RP (a requirement if randomised to adjuvant RT arm)
• Most recent PSA = 0.10 ng/ml following RP and prior to randomisation
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
• Patient able to adhere to the specified follow-up schedule and complete the Quality of Life and anxiety/depression self-assessments
• Written informed consent obtained prior to randomisation
• Completion of all pre-treatment evaluations
• 18 years and older

Exclusion Criteria:

• Previous pelvic RT
• Androgen deprivation (AD) prior to or following RP
• Evidence of nodal or distant metastases
• Co-morbidities that would interfere with the completion of treatment and/or 5 years of follow-up
• Concurrent cytotoxic medication
• Hip prosthesis

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Adjuvant Radiotherapy
Adjuvant RT (ART) commenced within 4 months of Radical Prostatectomy. 64Gy in 32 fractions to the prostate bed.
• Early Salvage Radiotherapy
Active surveillance with early Salvage RT (SRT). SRT - 64Gy in 32 fractions to the prostate bed. RT should commence no later than 4 months following the first PSA measurement = 0.2ng/mL.

Locations

Country	Name	City	State
Australia	Campbelltown Hopsital	Campbelltown	New South Wales
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Coffs Harbour Health Campus, NCCI	Coffs Harbour	New South Wales
Australia	Radiation Oncology Associates	Darlinghurst	New South Wales
Australia	St Vincent's Clinic	Darlinghurst	New South Wales
Australia	Peter MacCallum Cancer Centre	East Melbourne	Victoria
Australia	Radiation Oncology Gold Coast	Gold Coast	Queensland
Australia	Austin Hospital	Heidelberg West	Victoria
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Nepean Hospital	Kingswood	New South Wales
Australia	St George Hospital	Kogarah	New South Wales
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	The Alfred/WBRC	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Oceania Oncology	Nambour	Queensland
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Calvary Mater Newcastle	Newcastle	New South Wales
Australia	Central West Cancer Services (Orange Health)	Orange	New South Wales
Australia	Perth Radiation Oncology	Perth	Western Australia
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Port Macquarie Base Hospital, NCCI	Port Macquarie	New South Wales
Australia	Radiation Oncology - Mater Centre	South Brisbane	Queensland
Australia	Royal North Shore Hospital	St Leonards	New South Wales
Australia	Toowoomba Cancer Research Centre	Toowoomba	Queensland
Australia	Townsville Hospital	Townsville	Queensland
Australia	Premion	Tugun	Queensland
Australia	Riverina Cancer Care Centre	Wagga Wagga	New South Wales
Australia	Sydney Adventist Hospital	Wahroonga	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
New Zealand	Auckland Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Dunedin Hospital	Dunedin
New Zealand	Auckland Radiation Oncology	Epsom	Auckland
New Zealand	Wellington Hospital	Newtown	Wellington
New Zealand	Palmerston North Hospital	Palmerston North

Sponsors (3)

Lead Sponsor	Collaborator
Trans Tasman Radiation Oncology Group	Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Urological Society of Australia and New Zealand (USANZ)

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical failure: PSA = 0.4 ng/ml and rising following RT		After 160 events have been observed, expected to be 5 years after recruitment closes
Secondary	Quality of Life		Final Analysis will be after 160 events, estimated to be five years after the end of accrual
Secondary	Toxicity		Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Secondary	Anxiety/Depression		Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Secondary	Biochemical failure-free survival		Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Secondary	Overall survival		Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Secondary	Disease-specific survival		Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Secondary	Time to distant failure		Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Secondary	Time to local failure		Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Secondary	Time to the initiation of androgen ablation		Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Secondary	Quality adjusted life years		Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Secondary	Cost-utility		Final analysis will be after 160 events, estimated to be 5 years after end of accrual.

External Links

•   Trans Tasman Radiation Oncology Group