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Radiotherapy - Adjuvant Versus Early Salvage

NCT00860652 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 333

Last updated 2022-11-18

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

Adjuvant Radiotherapy

Adjuvant RT (ART) commenced within 4 months of Radical Prostatectomy. 64Gy in 32 fractions to the prostate bed.

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.

Sponsors & Collaborators

  • Urological Society of Australia and New Zealand (USANZ)

    collaborator UNKNOWN

  • Australian and New Zealand Urogenital and Prostate Cancer Trials Group

    collaborator OTHER

  • Trans Tasman Radiation Oncology Group

    lead OTHER

Principal Investigators

  • Maria Pearse, MBChB · Trans Tasman Radiation Oncology Group

  • Andrew Kneebone · Trans Tasman Radiation Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-03
Primary Completion
2022-12-31
Completion
2026-12-31

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00860652 on ClinicalTrials.gov