CompletedPhase 3ACTRN12607000097448

A randomised trial investigating the effect on biomedical (PSA) control and survival of different durations of adjuvant androgen deprivation in association with definite radiation treatment for localised carcinoma of the prostate (RADAR)

Trans Tasman Radiation Oncology Group (TROG) 03.04 - A randomised trial investigating the effect on biomedical (Prostate Specific Antigen- PSA) control and survival of different durations of adjuvant androgen (Leuprorelin acetate and zoledronic acid)deprivation in association with definite radiation treatment for localised carcinoma of the prostate (The RADAR trial)


Sponsor

Trans Tasman Radiation Oncology Group (TROG)

Enrollment

1,000 participants

Start Date

Oct 23, 2003

Study Type

Interventional

Conditions

Summary

Six months of hormone treatment improves the results of radiotherapy for men with early prostate cancer. This trial will determine if adding another 12 months of hormone treatment after radiotherapy is even better. Bones are often affected by prostate cancer and can also be damaged by prolong hormone treatment. Bisphosphonates are drugs that make bones stronger. This trial will also determine if treatment with a bisphosphonate can help prevent these bone problems.


Eligibility

Sex: MalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This trial (called RADAR) studies how different durations of hormone therapy combined with radiation treatment affect outcomes in men with localized prostate cancer. It is for men with confirmed prostate adenocarcinoma at moderate to advanced stages who have no evidence of cancer spread. Participants receive radiation along with varying lengths of androgen deprivation therapy.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Androgen deprivation: artificial drugs create a depression in the production of sex hormones. Arm A: Androgen deprivation (AD): 6 months Luteinising Hormone - Releasing Hormone (LH-RH) analogue (Leu

Androgen deprivation: artificial drugs create a depression in the production of sex hormones. Arm A: Androgen deprivation (AD): 6 months Luteinising Hormone - Releasing Hormone (LH-RH) analogue (Leuprorelin acetate 22.5mg) depot injected every 3 months, at 0 and 3 months. Radiation begins after 5 months AD. Arm B: Androgen deprivation: 6 months LH-RH analogue (Leuprorelin acetate 22.5mg) depot injected every 3 months, at 0 and 3 months. Radiation begins after 5 months AD. Bisphosphonate therapy (Zoledronic acid 4mg) every 3 months for 18 months by IV. Arm C: Androgen deprivation: 18 months LH-RH analogue (Leuprorelin acetate 22.5mg) depot injected every 3 months at 0, 3, 6, 9, 12 and 15 months. Radiation treatment begins after 5 months AD. Arm D: Andorgen deprivation: 18 months LH-RH analogue (Leuprorelin acetate 22.5mg) depot injected every 3 months at 0, 3, 6, 9, 12 and 15 months. Radiation treatment begins after 5 months AD. Bisphosphonate therapy (Zoledronic acid 4mg) every 3 months for 18 months by IV. Radiation will be 66Gy in 33 fractions of 2gy in all cases for a period of 8 weeks.


Locations(1)

New Zealand

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12607000097448