Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer

Sponsor
City of Hope Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00544830
Collaborator
National Cancer Institute (NCI) (NIH)
29
2
1
197.5
14.5
0.1

Study Details

Study Description

Brief Summary

This phase II trial studies how well hormone therapy and intensity-modulated radiation therapy work in treating patients with prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Anti-hormone therapy using goserelin, leuprolide acetate, or bicalutamide, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. 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. Giving hormone therapy and intensity-modulated radiation therapy may work better in treating patients with prostate cancer.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bicalutamide
  • Drug: Goserelin Acetate
  • Radiation: Intensity-Modulated Radiation Therapy
  • Other: Laboratory Biomarker Analysis
  • Drug: Leuprolide Acetate
Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. To evaluate the time to prostate-specific antigen (PSA) relapse in patients with oligometastatic (=< 5 lesions) hormone-sensitive prostate cancer treated with 36 weeks of androgen deprivation therapy and localized radiotherapy to all known tumor sites.

  2. To assess the prostate-specific-antigen (PSA) and objective response rate to treatment with 36 weeks of androgen deprivation and localized radiotherapy in patients with oligometastatic hormone-sensitive prostate cancer.

  3. To assess the toxicity of 36 weeks of androgen deprivation and localized radiation therapy to oligometastases in patients with oligometastatic hormone-sensitive prostate cancer.

  4. In appropriate situations evaluate the feasibility and toxicities of using helical tomotherapy image-guided intensity-modulated radiation therapy (IMRT) to treat oligometastatic sites.

OUTLINE:

ANDROGEN DEPRIVATION THERAPY (ADT): Patients not currently on ADT receive goserelin acetate subcutaneously (SC) or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide orally (PO) once daily (QD). Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy.

RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.

After completion of study treatment, patients are followed up every 4 weeks for 2 years, then every 3 months after year 2, and then every 6 months thereafter.

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Androgen Deprivation and Localized Radiotherapy to Metastases in Patients With Oligometastatic Hormone - Sensitive Prostate Cancer
Actual Study Start Date :
Jul 18, 2006
Actual Primary Completion Date :
Mar 16, 2011
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (androgen therapy, radiation therapy)

ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy. RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.

Drug: Bicalutamide
Given PO
Other Names:
  • Casodex
  • Cosudex
  • ICI 176,334
  • ICI 176334
  • Drug: Goserelin Acetate
    Given SC
    Other Names:
  • ZDX
  • Zoladex
  • Radiation: Intensity-Modulated Radiation Therapy
    Undergo IMRT
    Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
  • Other: Laboratory Biomarker Analysis
    Correlative studies

    Drug: Leuprolide Acetate
    Given via injection
    Other Names:
  • A-43818
  • Abbott 43818
  • Abbott-43818
  • Carcinil
  • Depo-Eligard
  • Eligard
  • Enanton
  • Enantone
  • Enantone-Gyn
  • Ginecrin
  • LEUP
  • Leuplin
  • Leuprorelin Acetate
  • Lucrin
  • Lucrin Depot
  • Lupron
  • Lupron Depot
  • Lupron Depot-3 Month
  • Lupron Depot-4 Month
  • Lupron Depot-Ped
  • Procren
  • Procrin
  • Prostap
  • TAP-144
  • Trenantone
  • Uno-Enantone
  • Viadur
  • Outcome Measures

    Primary Outcome Measures

    1. Time to Prostate-specific Antigen (PSA) Relapse [End-of-therapy until PSA reached pre-treatment level or 10 (whichever was lower)]

      Time from the date of the last dose of bicalutamide or the last day of radiation therapy (whichever comes later) until the date criteria are met for PSA relapse. PSA relapse after completion of initial 36 weeks of androgen deprivation therapy is defined as an increase in PSA value to above pre-therapy level, or to > 10, whichever is smaller. For example, a patient with pre-treatment PSA level of 40 will resume androgen deprivation therapy when PSA level is > 10, while a patient with pre-treatment PSA level of 3 will resume androgen deprivation therapy when PSA level is > 3.

    Secondary Outcome Measures

    1. Patients Who Achieved PSA Nadir of < 0.2 at 36 Weeks. [During the time period between on-study PSA to off-study PSA, up to 36 weeks.]

      Number of Patients who achieved PSA nadir of < 0.2 at 36 weeks.

    2. Rate of Treatment Failure (no PSA Threshold Below 4 ng/dl, or no PSA Below Baseline Level Before LHRH Treatment). [Off-treatment PSA measurement date minus on-study PSA measurement date, up to 36 weeks.]

      Treatment failures: Count and percent of patients NOT reaching PSA concentration in serum either below 4 ng/dl or below baseline before LHRH treatment .

    3. Length of Follow-up [Patients are evaluated for disease on day 1 of each of three 12-week cycles. After the last cycle of anti-androgen therapy, patients are assessed every four weeks until PSA relapse occurs, up to 61.4 months]

      Length of follow-up in weeks to off-study date. Patients are treated for 36 weeks (+/- 2 weeks) with androgen deprivation therapy. Patients are evaluated for disease on day 1 of each of three 12-week cycles. After the last cycle of anti-androgen therapy, patients are assessed every four weeks until PSA relapse occurs, up to 264.8 weeks (61.4 months; 5.1 years). Patients will remain off-treatment until they meet the criteria for re-treatment with androgen deprivation therapy, whereupon they will be taken off of the protocol. After patients are taken off protocol, we will do a chart review for long-term outcomes.

    4. Count of Patients Remaining Off of Therapy [after 36 week LHRH treatment window.]

      Patients who remained off of therapy, in remission, out of the number of patients with metastases limited to pelvic lymph nodes.

    5. Follow-up of the 8 Patients With Metastases Limited to Pelvic Lymph Nodes. [Patients are followed on day one of each of three 12-week periods. After completion of therapy, patients are followed every four weeks until PSA relapse, up to 46.4 months.]

      Length of follow-up of the 8 patients with metastases limited to pelvic lymph nodes, months. Patients are followed on day one of each of three 12-week periods. After completion of therapy, patients are followed every four weeks until PSA relapse, up to 46.4 months.

    6. CR Without ADT in Patients With Metastases Limited to Pelvic Lymph Nodes. [after 36 weeks of LHRH therapy.]

      Number of patients remaining in complete remission without androgen deprivation therapy in patients with metastases limited to pelvic lymph nodes.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with histologically proven diagnosis of adenocarcinoma of the prostate stage N1, N2, N3, M1a, M1b, M1c with =< 5 metastatic lesions; if the diagnosis of metastasis in the lymph node is based solely on imaging computed tomography (CT) scan or magnetic resonance imaging (MRI), the longitudinal diameter of the lymph node has to be >= 2.0 cm; if the lymph node is positive on positron emission tomography (PET) or ProstaScint scan, the longitudinal diameter of the lymph node on CT scan or MRI has to be >= 1.5 cm

    • Patients who have measurable disease must have had X-rays, scans or physical examination used for tumor measurement completed within 28 days prior to registration; patients must have non-measurable disease assessed within 42 days prior to registration

    • Patients must have had documented PSA of > 2 prior to onset of androgen deprivation

    • Patients might have received up to 36 weeks of adjuvant androgen deprivation therapy and up to 36 weeks of androgen deprivation therapy for metastatic disease prior to enrollment to this study; patients may be on androgen deprivation for metastatic disease at the time of enrollment to the protocol; adjuvant therapy must have been completed at least 2 years before androgen deprivation for metastatic disease and patients must remain hormone sensitive

    • Prior radiation therapy for metastatic disease is not allowed

    • Prior chemotherapy for metastatic disease is not allowed; prior neoadjuvant and adjuvant chemotherapy is allowed; patients must have recovered from all acute side-effects related to previous systemic therapy

    • Patients are allowed to receive one prior systemic non-chemotherapeutic treatment (i.

    1. immunotherapy, receptor tyrosine kinase inhibitor, antiangiogenic agent, differentiation agent) for recurrent or metastatic disease; patients must have recovered from all acute side-effects related to previous systemic therapy
    • Use of bisphosphonates is allowed at the discretion of treating physician

    • Patients must be capable of understanding the nature of the trial and must give written informed consent

    • Patients must have a World Health Organization (WHO) performance status of 0, 1, or 2

    Exclusion Criteria:
    • Patients with unstable or severe intercurrent medical conditions or active, uncontrolled infection

    • Patients with a history of orchiectomy

    • Patients undergoing therapy with other investigational agents; patients must have recovered from all acute effects of previously administered investigational agents and sufficient time must have elapsed since last administration to ensure the drug interactions not occur during this study

    • Patients with a history of brain metastases or who currently have treated or untreated brain metastases

    • Patients who have demonstrated refractoriness to hormone therapy with luteinizing hormone-releasing hormone (LHRH) agonist; refractoriness is defined as occurrence of one of the following while on therapy with LHRH agonist: increase in PSA by 25% over baseline (to at least > 2 ng/ml) on two consecutive PSA measurements, 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, clear worsening of any non-measurable disease, reappearance of any lesion that had disappeared, appearance of any new lesion

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Medical Center Duarte California United States 91010
    2 City of Hope South Pasadena South Pasadena California United States 91030

    Sponsors and Collaborators

    • City of Hope Medical Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Cy A Stein, City of Hope Medical Center

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT00544830
    Other Study ID Numbers:
    • 05190
    • NCI-2010-00425
    • 05190
    • P30CA033572
    First Posted:
    Oct 16, 2007
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Apr 1, 2022
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details The first patient was consented on July 18, 2006. The last eligible patient was consented on August 25, 2010. Patients were recruited at City of Hope National Medical Center.
    Pre-assignment Detail
    Arm/Group Title Treatment (Androgen Therapy, Radiation Therapy)
    Arm/Group Description ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy. RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy. Bicalutamide: Given PO Goserelin Acetate: Given SC Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given via injection
    Period Title: Overall Study
    STARTED 29
    COMPLETED 29
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Treatment (Androgen Therapy, Radiation Therapy)
    Arm/Group Description ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy. RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy. Bicalutamide: Given PO Goserelin Acetate: Given SC Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given via injection
    Overall Participants 29
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    10
    34.5%
    >=65 years
    19
    65.5%
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    66.9
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    Male
    29
    100%
    Region of Enrollment (Count of Participants)
    United States
    29
    100%
    Baseline Prostate Specific Antigen (PSA) (ng/ml) [Median (Full Range) ]
    Median (Full Range) [ng/ml]
    11.4
    Metastases limited to pelvic lymph nodes (Count of Participants)
    Count of Participants [Participants]
    8
    27.6%

    Outcome Measures

    1. Primary Outcome
    Title Time to Prostate-specific Antigen (PSA) Relapse
    Description Time from the date of the last dose of bicalutamide or the last day of radiation therapy (whichever comes later) until the date criteria are met for PSA relapse. PSA relapse after completion of initial 36 weeks of androgen deprivation therapy is defined as an increase in PSA value to above pre-therapy level, or to > 10, whichever is smaller. For example, a patient with pre-treatment PSA level of 40 will resume androgen deprivation therapy when PSA level is > 10, while a patient with pre-treatment PSA level of 3 will resume androgen deprivation therapy when PSA level is > 3.
    Time Frame End-of-therapy until PSA reached pre-treatment level or 10 (whichever was lower)

    Outcome Measure Data

    Analysis Population Description
    Metastatic prostate cancer patients treated with androgen deprivation.
    Arm/Group Title Treatment (Androgen Therapy, Radiation Therapy)
    Arm/Group Description ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy. RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy. Bicalutamide: Given PO Goserelin Acetate: Given SC Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given via injection
    Measure Participants 29
    Median (95% Confidence Interval) [month]
    16.5
    2. Secondary Outcome
    Title Patients Who Achieved PSA Nadir of < 0.2 at 36 Weeks.
    Description Number of Patients who achieved PSA nadir of < 0.2 at 36 weeks.
    Time Frame During the time period between on-study PSA to off-study PSA, up to 36 weeks.

    Outcome Measure Data

    Analysis Population Description
    Patients who achieved PSA nadir of < 0.2 at 36 weeks.
    Arm/Group Title Treatment (Androgen Therapy, Radiation Therapy)
    Arm/Group Description ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy. RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy. Bicalutamide: Given PO Goserelin Acetate: Given SC Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given via injection
    Measure Participants 29
    Count of Participants [Participants]
    25
    86.2%
    3. Secondary Outcome
    Title Rate of Treatment Failure (no PSA Threshold Below 4 ng/dl, or no PSA Below Baseline Level Before LHRH Treatment).
    Description Treatment failures: Count and percent of patients NOT reaching PSA concentration in serum either below 4 ng/dl or below baseline before LHRH treatment .
    Time Frame Off-treatment PSA measurement date minus on-study PSA measurement date, up to 36 weeks.

    Outcome Measure Data

    Analysis Population Description
    Metastatic prostate cancer patients treated with androgen deprivation therapy.
    Arm/Group Title Treatment (Androgen Therapy, Radiation Therapy)
    Arm/Group Description ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy. RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy. Bicalutamide: Given PO Goserelin Acetate: Given SC Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given via injection
    Measure Participants 29
    Count of Participants [Participants]
    15
    51.7%
    4. Secondary Outcome
    Title Length of Follow-up
    Description Length of follow-up in weeks to off-study date. Patients are treated for 36 weeks (+/- 2 weeks) with androgen deprivation therapy. Patients are evaluated for disease on day 1 of each of three 12-week cycles. After the last cycle of anti-androgen therapy, patients are assessed every four weeks until PSA relapse occurs, up to 264.8 weeks (61.4 months; 5.1 years). Patients will remain off-treatment until they meet the criteria for re-treatment with androgen deprivation therapy, whereupon they will be taken off of the protocol. After patients are taken off protocol, we will do a chart review for long-term outcomes.
    Time Frame Patients are evaluated for disease on day 1 of each of three 12-week cycles. After the last cycle of anti-androgen therapy, patients are assessed every four weeks until PSA relapse occurs, up to 61.4 months

    Outcome Measure Data

    Analysis Population Description
    Patients with hormone sensitive prostate cancer
    Arm/Group Title Treatment (Androgen Therapy, Radiation Therapy)
    Arm/Group Description ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy. RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy. Bicalutamide: Given PO Goserelin Acetate: Given SC Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given via injection
    Measure Participants 29
    Median (Full Range) [week]
    111.4
    5. Secondary Outcome
    Title Count of Patients Remaining Off of Therapy
    Description Patients who remained off of therapy, in remission, out of the number of patients with metastases limited to pelvic lymph nodes.
    Time Frame after 36 week LHRH treatment window.

    Outcome Measure Data

    Analysis Population Description
    Patients with metastases limited to pelvic lymph nodes
    Arm/Group Title Treatment (Androgen Therapy, Radiation Therapy)
    Arm/Group Description ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy. RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy. Bicalutamide: Given PO Goserelin Acetate: Given SC Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given via injection
    Measure Participants 8
    Count of Participants [Participants]
    7
    24.1%
    6. Secondary Outcome
    Title Follow-up of the 8 Patients With Metastases Limited to Pelvic Lymph Nodes.
    Description Length of follow-up of the 8 patients with metastases limited to pelvic lymph nodes, months. Patients are followed on day one of each of three 12-week periods. After completion of therapy, patients are followed every four weeks until PSA relapse, up to 46.4 months.
    Time Frame Patients are followed on day one of each of three 12-week periods. After completion of therapy, patients are followed every four weeks until PSA relapse, up to 46.4 months.

    Outcome Measure Data

    Analysis Population Description
    Patients with metastases limited to pelvic lymph nodes.
    Arm/Group Title Treatment (Androgen Therapy, Radiation Therapy)
    Arm/Group Description ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy. RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy. Bicalutamide: Given PO Goserelin Acetate: Given SC Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given via injection
    Measure Participants 8
    Median (Full Range) [month]
    14.7
    7. Secondary Outcome
    Title CR Without ADT in Patients With Metastases Limited to Pelvic Lymph Nodes.
    Description Number of patients remaining in complete remission without androgen deprivation therapy in patients with metastases limited to pelvic lymph nodes.
    Time Frame after 36 weeks of LHRH therapy.

    Outcome Measure Data

    Analysis Population Description
    Patients with metastases limited to pelvic lymph nodes.
    Arm/Group Title Treatment (Androgen Therapy, Radiation Therapy)
    Arm/Group Description ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy. RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy. Bicalutamide: Given PO Goserelin Acetate: Given SC Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given via injection
    Measure Participants 8
    Count of Participants [Participants]
    4
    13.8%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Treatment (Androgen Therapy, Radiation Therapy)
    Arm/Group Description ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy. RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy. Bicalutamide: Given PO Goserelin Acetate: Given SC Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given via injection
    All Cause Mortality
    Treatment (Androgen Therapy, Radiation Therapy)
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Treatment (Androgen Therapy, Radiation Therapy)
    Affected / at Risk (%) # Events
    Total 1/29 (3.4%)
    Gastrointestinal disorders
    10012727 -- Diarrhea 1/29 (3.4%) 1
    Psychiatric disorders
    10010300 -- Confusion 1/29 (3.4%) 1
    Other (Not Including Serious) Adverse Events
    Treatment (Androgen Therapy, Radiation Therapy)
    Affected / at Risk (%) # Events
    Total 28/29 (96.6%)
    Blood and lymphatic system disorders
    10019483 -- Hemoglobin decreased 20/29 (69%) 20
    10019483 -- Hemoglobin decreased 1/29 (3.4%) 1
    Cardiac disorders
    10003658 -- Atrial fibrillation 1/29 (3.4%) 1
    10003668 -- Atrial tachycardia 1/29 (3.4%) 1
    10040741 -- Sinus bradycardia 6/29 (20.7%) 6
    Ear and labyrinth disorders
    10019246 -- Hearing loss 1/29 (3.4%) 1
    Endocrine disorders
    10014695 -- Endocrine disorder 1/29 (3.4%) 1
    Gastrointestinal disorders
    10000081 -- Abdominal pain 1/29 (3.4%) 1
    10010774 -- Constipation 3/29 (10.3%) 3
    10012727 -- Diarrhea 15/29 (51.7%) 15
    10013950 -- Dysphagia 2/29 (6.9%) 2
    10015461 -- Esophagitis 1/29 (3.4%) 1
    10016766 -- Flatulence 3/29 (10.3%) 3
    10017944 -- Gastrointestinal disorder 4/29 (13.8%) 4
    10018286 -- Gingival pain 1/29 (3.4%) 1
    10019611 -- Hemorrhoids 8/29 (27.6%) 8
    10028813 -- Nausea 4/29 (13.8%) 4
    10036774 -- Proctitis 1/29 (3.4%) 1
    10036787 -- Proctoscopy abnormal 1/29 (3.4%) 1
    10038064 -- Rectal hemorrhage 2/29 (6.9%) 2
    10038072 -- Rectal pain 1/29 (3.4%) 1
    10047700 -- Vomiting 2/29 (6.9%) 2
    10056848 -- Ear, nose and throat examination abnormal 1/29 (3.4%) 1
    10065709 -- Rectal necrosis 1/29 (3.4%) 1
    10012727 -- Diarrhea 2/29 (6.9%) 2
    10028813 -- Nausea 1/29 (3.4%) 1
    General disorders
    10008479 -- Chest pain 2/29 (6.9%) 2
    10016256 -- Fatigue 14/29 (48.3%) 14
    10016558 -- Fever 1/29 (3.4%) 1
    10033371 -- Pain 1/29 (3.4%) 1
    10050068 -- Edema limbs 4/29 (13.8%) 4
    90004082 -- Pain 3/29 (10.3%) 3
    10008531 -- Chills 1/29 (3.4%) 1
    10016558 -- Fever 1/29 (3.4%) 1
    90004082 -- Pain 1/29 (3.4%) 1
    Immune system disorders
    10020751 -- Hypersensitivity 1/29 (3.4%) 1
    Infections and infestations
    10021789 -- Infection 1/29 (3.4%) 1
    90031098 -- Upper respiratory infection 1/29 (3.4%) 1
    90031102 -- Urinary tract infection 1/29 (3.4%) 1
    Injury, poisoning and procedural complications
    10061103 -- Dermatitis radiation 3/29 (10.3%) 3
    10065892 -- Small intestinal anastomotic leak 1/29 (3.4%) 1
    10061103 -- Dermatitis radiation 1/29 (3.4%) 1
    Investigations
    10001551 -- Alanine aminotransferase increased 6/29 (20.7%) 6
    10001675 -- Alkaline phosphatase increased 1/29 (3.4%) 1
    10003481 -- Aspartate aminotransferase increased 9/29 (31%) 9
    10011349 -- Creatine phosphokinase increased 2/29 (6.9%) 2
    10011368 -- Creatinine increased 2/29 (6.9%) 2
    10025256 -- Lymphocyte count decreased 18/29 (62.1%) 18
    10029366 -- Neutrophil count decreased 2/29 (6.9%) 2
    10035528 -- Platelet count decreased 12/29 (41.4%) 12
    10040190 -- Serum cholesterol increased 2/29 (6.9%) 2
    10047896 -- Weight gain 2/29 (6.9%) 2
    10048552 -- Leukocyte count decreased 18/29 (62.1%) 18
    10024384 -- Leukopenia 2/29 (6.9%) 2
    10025327 -- Lymphopenia 1/29 (3.4%) 1
    10035528 -- Platelet count decreased 1/29 (3.4%) 1
    Metabolism and nutrition disorders
    10002646 -- Anorexia 2/29 (6.9%) 2
    10005557 -- Blood glucose increased 10/29 (34.5%) 10
    10012174 -- Dehydration 1/29 (3.4%) 1
    10040123 -- Serum albumin decreased 1/29 (3.4%) 1
    10040175 -- Serum calcium increased 6/29 (20.7%) 6
    10040268 -- Serum glucose decreased 2/29 (6.9%) 2
    10040336 -- Serum magnesium decreased 1/29 (3.4%) 1
    10040378 -- Serum potassium decreased 1/29 (3.4%) 1
    10040379 -- Serum potassium increased 2/29 (6.9%) 2
    10040405 -- Serum sodium increased 1/29 (3.4%) 1
    10040424 -- Serum triglycerides increased 2/29 (6.9%) 2
    10054863 -- Serum sodium decreased 2/29 (6.9%) 2
    10021018 -- Hypokalemia 1/29 (3.4%) 1
    Musculoskeletal and connective tissue disorders
    10003246 -- Arthritis 4/29 (13.8%) 4
    10003988 -- Back pain 7/29 (24.1%) 7
    10006002 -- Bone pain 1/29 (3.4%) 1
    10023222 -- Joint pain 2/29 (6.9%) 2
    10028411 -- Myalgia 1/29 (3.4%) 1
    10028836 -- Neck pain 2/29 (6.9%) 2
    10031282 -- Osteoporosis 3/29 (10.3%) 3
    10033425 -- Pain in extremity 2/29 (6.9%) 2
    Nervous system disorders
    10013573 -- Dizziness 2/29 (6.9%) 2
    10019211 -- Headache 2/29 (6.9%) 2
    10029298 -- Neurological disorder NOS 1/29 (3.4%) 1
    10034620 -- Peripheral sensory neuropathy 3/29 (10.3%) 3
    Psychiatric disorders
    10002855 -- Anxiety 4/29 (13.8%) 4
    10012378 -- Depression 1/29 (3.4%) 1
    10022437 -- Insomnia 2/29 (6.9%) 2
    10024419 -- Libido decreased 2/29 (6.9%) 2
    Renal and urinary disorders
    10011781 -- Cystitis 1/29 (3.4%) 1
    10019591 -- Hemorrhage urinary tract 4/29 (13.8%) 4
    10037020 -- Protein urine positive 2/29 (6.9%) 2
    10038435 -- Renal failure 1/29 (3.4%) 1
    10046461 -- Urethral pain 4/29 (13.8%) 4
    10046539 -- Urinary frequency 22/29 (75.9%) 22
    10046543 -- Urinary incontinence 6/29 (20.7%) 6
    10046555 -- Urinary retention 4/29 (13.8%) 4
    10046694 -- Urogenital disorder 2/29 (6.9%) 2
    10046694 -- Urogenital disorder 1/29 (3.4%) 1
    Reproductive system and breast disorders
    10034310 -- Penile pain 1/29 (3.4%) 1
    10036968 -- Prostatic pain 1/29 (3.4%) 1
    10061461 -- Erectile dysfunction 10/29 (34.5%) 10
    10018801 -- Gynecomastia 1/29 (3.4%) 1
    Respiratory, thoracic and mediastinal disorders
    10011224 -- Cough 1/29 (3.4%) 1
    10013963 -- Dyspnea 1/29 (3.4%) 1
    10034844 -- Pharyngolaryngeal pain 1/29 (3.4%) 1
    10035598 -- Pleural effusion 1/29 (3.4%) 1
    10047681 -- Voice alteration 1/29 (3.4%) 1
    Skin and subcutaneous tissue disorders
    10001760 -- Alopecia 2/29 (6.9%) 2
    10013786 -- Dry skin 3/29 (10.3%) 3
    10037087 -- Pruritus 1/29 (3.4%) 1
    10037853 -- Rash desquamating 5/29 (17.2%) 5
    10040831 -- Skin disorder 1/29 (3.4%) 1
    10040865 -- Skin hyperpigmentation 2/29 (6.9%) 2
    Vascular disorders
    10020407 -- Hot flashes 18/29 (62.1%) 18
    10020772 -- Hypertension 1/29 (3.4%) 1
    10021097 -- Hypotension 1/29 (3.4%) 1
    10020407 -- Hot flashes 1/29 (3.4%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Cy Stein
    Organization City of Hope
    Phone 626-359-8111
    Email
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT00544830
    Other Study ID Numbers:
    • 05190
    • NCI-2010-00425
    • 05190
    • P30CA033572
    First Posted:
    Oct 16, 2007
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Apr 1, 2022