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Radiotherapy - Adjuvant Versus Early Salvage (RAVES)

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ClinicalTrials.gov Identifier: NCT00860652
Recruitment Status : Active, not recruiting
First Posted : March 12, 2009
Last Update Posted : March 13, 2020
Sponsor:
Collaborators:
Urological Society of Australia and New Zealand (USANZ)
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)

Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Adjuvant Radiotherapy Radiation: Early Salvage Radiotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 333 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Actual Study Start Date : March 3, 2009
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: Final Analysis will be after 160 events, estimated to be five years after the end of accrual ]
  2. Toxicity [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ]
  3. Anxiety/Depression [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ]
  4. Biochemical failure-free survival [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ]
  5. Overall survival [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ]
  6. Disease-specific survival [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ]
  7. Time to distant failure [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ]
  8. Time to local failure [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ]
  9. 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. ]
  10. Quality adjusted life years [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ]
  11. Cost-utility [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860652


Locations
Show Show 36 study locations
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Urological Society of Australia and New Zealand (USANZ)
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Investigators
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Study Chair: Maria Pearse, MBChB Trans-Tasman Radiation Oncology Group (TROG)
Study Chair: Andrew Kneebone Trans-Tasman Radiation Oncology Group (TROG)
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT00860652    
Other Study ID Numbers: TROG 08.03
First Posted: March 12, 2009    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
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:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases