Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Androgen Deprivation Therapy for Metastatic Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00544830|
Recruitment Status : Active, not recruiting
First Posted : October 16, 2007
Last Update Posted : December 2, 2017
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy, such as goserelin, leuprolide, or bicalutamide, may lessen the amount of androgens made by the body. Giving intensity-modulated radiation therapy together with androgen deprivation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well intensity-modulated radiation therapy works in treating patients undergoing androgen deprivation therapy for metastatic prostate cancer.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: bicalutamide Drug: goserelin Drug: leuprolide acetate Radiation: intensity-modulated radiation therapy Radiation: tomotherapy||Phase 2|
- 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 regimen.
- 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 deprivation therapy.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Androgen Deprivation and Localized Radiotherapy to Metastases in Patients With Oligometastatic Hormone - Sensitive Prostate Cancer|
|Actual Study Start Date :||July 18, 2006|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
Experimental: Androgen Deprivation and Radiation Therapy
Androgen deprivation subcutaneously with goserelin or leuprolide, radiation therapy to all known metastatic sites.
50 mg orally every day for a total of 36 weeks (+/- 2 weeks)Drug: goserelin
3.6 mg subcutaneously every 4 weeks or 10.8 mg subcutaneously every 12 weeks for a total of 36 weeks (+/- 2 weeks)Drug: leuprolide acetate
22.5 mg intramuscularly every 12 weeks for a total of 36 weeks (+/- 2 weeks)Radiation: intensity-modulated radiation therapy
All sites will be treated using one of the following fractionation schemes: 1) 300 cGy/day to 3000 cGy; 2) 250 cGy/day to 3750 cGy; 3) 200 cGy/day to 4000 cGy.Radiation: tomotherapy
All sites will be treated using one of the following fractionation schemes: 1) 300 cGy/day to 3000 cGy; 2) 250 cGy/day to 3750 cGy; 3) 200 cGy/day to 4000 cGy.
- Time to PSA relapse [ Time Frame: One year from the end of treatment ]
- PSA response to treatment [ Time Frame: One year from the end of treatment ]
- Safety as assessed by NCI CTCAE v3.0 [ Time Frame: One year from the end of treatment ]
- Feasibility [ Time Frame: One year from the end of treatment ]
- Tolerability as assessed by NCI CTCAE v3.0 [ Time Frame: One year from the end of treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544830
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010-3000|
|City of Hope Medical Group|
|Pasadena, California, United States, 91105|
|Principal Investigator:||Cy Stein, MD, PhD||City of Hope Comprehensive Cancer Center|