Prostatic Neoplasms, Locally Advanced Clinical Trial
Official title:
Comparative Efficacy and Safety of Combined Radiotherapy and Adjuvant Hormone Therapy (Leuprorelin SR 11.25 mg) and Hormone Therapy Alone (Leuprorelin SR 11.25 mg) in Locally Advanced Prostate Cancer (T3-T4 or pT3 on Biopsy, N0, M0)
The purpose of this study is to compare the efficacy and safety of combined radiotherapy and hormone therapy and hormone therapy alone in the treatment of clinically locally advanced prostate cancer (T3-T4 or pT3 on biopsy, N0, M0).
The drug being tested in this study is called leuprorelin SR. Leuprorelin SR is being tested
to treat people who have prostate cancer. This study will look at the overall survival of
people who take leuprorelin SR in addition to radiation therapy compared to those who take
only leuprorelin SR.
The study will enroll approximately 273 patients. Participants will be randomly assigned to
one of the two treatment groups.
- Combined Radiotherapy and Hormone Therapy
- Hormone Therapy alone. All participants will receive leuprorelin injection every 3
months and flutamide tablets thrice daily for first 30 days as part of hormone therapy.
Participants randomized to combined radiotherapy and hormone therapy group, will also
receive radiotherapy 70 +/- 4 Gy in 35 fractions at a rate of 5 fractions of 2 Gy per
week.
This multi-center trial will be conducted in France and Tunisia. The overall time to
participate in this study is 8 years. The scheduled duration of hormone therapy was 3 years
in both arms, with an additional treatment-free follow-up period of 2 years i.e. a total
follow-up period of 5 years. Post-protocol collection of information relative to survival
will be performed after the end the 5-year follow-up period.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment