Androgen Deprivation and Localized Radiotherapy to Metastases in Patients With Oligometastatic Hormone - Sensitive Prostate Cancer
- To evaluate the time to PSA relapse in patients with oligometastatic (i.e., ≤ 5
lesions) hormone-sensitive prostate cancer treated with 36 weeks of androgen
deprivation therapy and localized radiotherapy to all known tumor sites.
- To assess the PSA and objective tumor response rate in patients treated with this
- To assess the toxicity of this regimen in these patients.
- To evaluate the feasibility and toxicities of using helical tomotherapy image-guided
intensity-modulated radiotherapy to treat oligometastatic sites in these patients.
OUTLINE: Patients are stratified according to androgen-deprivation therapy status at time of
study entry (currently receiving or planning to receive vs completed or almost completed).
Patients who are not currently androgen deprivation therapy at the time of enrollment
receive 36 weeks of androgen deprivation therapy comprising goserelin subcutaneously or
leuprolide acetate intramuscularly once every 4-12 weeks and oral bicalutamide once daily
for 36 weeks. Patients who are already receiving androgen deprivation therapy at the time of
enrollment will continue treatment until they have received a total of 36 weeks of therapy.
All patients undergo helical tomotherapy image-guided intensity-modulated radiotherapy
beginning at the time they achieve PSA normalization (i.e., stable or declining PSA level ≤
4 ng/mL or stable or declining PSA level ≤ pretreatment level, whichever is smaller) on two
consecutive measurements taken after androgen deprivation therapy is initiated. All known
metastatic sites are irradiated for 2-7 weeks during or after completion of androgen
Patients remain off treatment until PSA relapse, defined as an increase in the PSA level to
the pre-androgen deprivation therapy level or > 10 ng/mL, whichever is smaller. Once the
patient meets the criteria for re-treatment with androgen deprivation therapy, they are
removed from study.
After completion of study therapy, patients are followed periodically.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to PSA relapse
One year from the end of treatment
Przemyslaw W. Twardowski, MD
Beckman Research Institute
United States: Institutional Review Board
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|City of Hope Medical Group||Pasadena, California 91105|