Radiotherapy following radical prostatectomy - Adjuvant Versus Early Salvage

• Register: ANZCTR
• Last refreshed on: 22 February 2013
• Main ID: ACTRN12611000781943
• Date of registration: 26/07/2011
• Primary sponsor: Other Collaborative groups Trans Tasman Radiation Oncology Group (TROG)
• Public title: Radiotherapy following radical prostatectomy - Adjuvant Versus Early Salvage RAVES
• Scientific title: Trans Tasman Radiation Oncology Group (TROG) 08.03 - A Phase III Multi-Centre Randomised Trial Comparing biochemical failure following Adjuvant Radiotherapy (RT) versus Early Salvage RT in Patients With Positive Margins or Extraprostatic Disease Following Radical Prostatectomy.
• Date of first enrolment: 30/03/2009
• Target sample size: 470
• Recruitment status: Recruiting
• URL: http://www.anzctr.org.au/ACTRN12611000781943.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Parallel

Countries of recruitment

Australia,Outside, New Zealand

Contacts

• Name: Ms Carol Fraser-Browne

• Name: A/Prof Andrew Kneebone

Key inclusion & exclusion criteria

Inclusion criteria: 1. Prior radical prostatectomy (RP) for adenocarcinoma of the prostate. 2. Histological confirmation of adenocarcinoma of the prostate with Gleason score reported (RP specimen). 3. Patients must have at least one of the following risk factors: a) positive margins, b) extraprostatic extension (EPE) with or without seminal vesicle involvement (pT3a or pT3b). 4. Capable of starting RT within 4 months of RP (a requirement if randomised to adjuvant RT arm). 5. Most recent PSA <= 0.1ng/ml following RP and prior to randomisation. 6. European Cooperative Oncology Group (ECOG) performance status 0-1. 7. Patient able to adhere to the specified follow-up schedule and complete the Quality Of Life and anxiety/depression self assessments. 8. Written informed consent obtained prior to randomisation. 9. Completion of all pre-treatment evaluations. 10. 18 years or older.
Exclusion criteria: 1. Previous pelvic RT. 2. Concurrent or previous malignancy 5 years prior to randomisation (except non-melanomatous skin cancer). 3. Androgen deprivation (AD) prior to or following RP. 4. Evidence of nodal or distant metastases. 5. Co-morbidities that would interfere with the completion of treatment or 5 years of follow-up. 6. Concurrent cytotoxic medication. 7. Hip prothesis

Age minimum: 18 Years
Age maximum: 0 No limit
Gender: Males

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Arm 1: Standard Arm - Adjuvant Radiotherapy. Radiation: Adjuvant radiation therapy (ART) commenced within 4 months of Radical Prostatectomy (RP). 64Gy in 32 fractions to the prostate bed, radiotherapy will be delivered 1 fraction/day over approx 6.5 weeks.

Primary Outcome(s)

Biochemical failure: PSA >=0.4ng/ml and rising following RT. PSA will be measured through blood tests.

Secondary Outcome(s)

Anxiety/Depression. Measured using the Hospital Anxiety and Depression Scale (HADS).

Biochemical Failure free survival. Measured from date of randomisation to date of biochemical failure or death from any cause. Measured via Blood PSA tests.

Diseaese specific survival. Measured from the date of randomisation to date of death due to prostate cancer. Data linkage to medical records

Overall Survival. Measured from date of randomisation to date of death from any cause. Local sites are responsible for reporting patient survival status. A patient will not be reported to have died unless there is source data confirming the patient?s death. Examples of potential source data are the patient?s medical records, obituaries, public records, death certificate, or information provided by a GP, hospice staff, or patient family members. If a patient is lost to follow-up, death will not be assumed unless confirmatory source data is available. The trial forms have been designed to allow sites to report lost to follow-up and death as separate events.

Quality Adjusted Life Years. Assessing efficacy and Quality of Life.

Quality of Life. European Organisation for Research and Treatment of Cancer (EORTC) core quality of Life questionnaire (QLQ-C30) and EORTC (prostate Cancer module) QLQ-PR25 questionnaires

Time to distant failure. Measured from date of randomisation to date of documented regional, nodal or distant failure. Nodal failure - diagnosed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) of pelvis/abdomen.
Bone Metastases - confirmed on x-ray, bone scan, CT/MRI.

Time to initiation of androgen ablation. Measured from date of randomisation to the date of initiaion of androgen deprivation.

Time to local failure. Measured from date of randomisation to date of documented palpable or biopsy-proven local failure.

Toxicity. Measured using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Effects (CTCAE) v 3.0

Secondary ID(s)

ClinicalTrials.gov ID NCT00860652

Source(s) of Monetary Support

Auckland City Hospital

Australian National Health and Research Council

New Zealand Health and Research Council

Royal Australian and New Zealand College of Radiologists

Cancer Council NSW

Cancer Council Victoria

Trans Tasman Radiation Oncology Group