Radiotherapy - Adjuvant Versus Early Salvage (RAVES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Trans-Tasman Radiation Oncology Group (TROG)
Sponsor:
Collaborators:
Urological Society of Australia and New Zealand (USANZ)
Australian & New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00860652
First received: March 10, 2009
Last updated: August 12, 2015
Last verified: August 2015
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Radiation: Adjuvant Radiotherapy
Radiation: Early Salvage Radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:
  • Biochemical failure: PSA ≥ 0.4 ng/ml and rising following RT [ Time Frame: After 160 events have been observed, expected to be 5 years after recruitment closes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Final Analysis will be after 160 events, estimated to be five years after the end of accrual ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ] [ Designated as safety issue: Yes ]
  • Anxiety/Depression [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ] [ Designated as safety issue: No ]
  • Biochemical failure-free survival [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ] [ Designated as safety issue: No ]
  • Disease-specific survival [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ] [ Designated as safety issue: No ]
  • Time to distant failure [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ] [ Designated as safety issue: No ]
  • Time to local failure [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ] [ Designated as safety issue: No ]
  • Time to the initiation of androgen ablation [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ] [ Designated as safety issue: No ]
  • Quality adjusted life years [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ] [ Designated as safety issue: No ]
  • Cost-utility [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ] [ Designated as safety issue: No ]

Estimated Enrollment: 470
Study Start Date: March 2009
Estimated Study Completion Date: December 2026
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adjuvant Radiotherapy (RT)
Adjuvant Radiotherapy (64Gy in 32 Fractions to the prostate bed)
Radiation: Adjuvant Radiotherapy
Adjuvant RT (ART) commenced within 4 months of Radical Prostatectomy. 64Gy in 32 fractions to the prostate bed.
Other Name: ART, Radiation
Experimental: Active Surveillance with Early SalvageRT
Active Surveillance with Early Salvage Radiotherapy
Radiation: 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.
Other Name: SRT, Surveillance, Radiation

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860652

Contacts
Contact: Carol Fraser-Browne +64 9 307 4949 ext 23044 carolFB@adhb.govt.nz

  Show 39 Study Locations
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Urological Society of Australia and New Zealand (USANZ)
Australian & New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)
Investigators
Study Chair: Maria Pearse, MBChB Trans-Tasman Radiation Oncology Group (TROG)
Study Chair: Andrew Kneebone Trans-Tasman Radiation Oncology Group (TROG)
  More Information

Additional Information:
No publications provided

Responsible Party: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT00860652     History of Changes
Other Study ID Numbers: TROG 08.03
Study First Received: March 10, 2009
Last Updated: August 12, 2015
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Oncology
Prostate Cancer
Radiotherapy
Radical Prostatectomy
Prior Radical Prostatectomy (RP)
Histological Confirmation of adenocarcinoma of the prostate
Positive margins and/or extraprostatic extension (EPE)

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on September 03, 2015