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Trial record 1 of 1 for:    RTOG0924
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Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Radiation Therapy Oncology Group
Sponsor:
Collaborators:
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01368588
First received: June 7, 2011
Last updated: November 13, 2014
Last verified: November 2014
  Purpose

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells.

PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.


Condition Intervention Phase
Prostate Cancer
Radiation: radiation therapy
Radiation: Whole-pelvic radiotherapy (WPRT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: From date of randomization to the date of death. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cause-specific survival [ Time Frame: From date of randomization to the date of death due to prostate cancer. ] [ Designated as safety issue: No ]
  • Distant metastasis-free survival [ Time Frame: From date of randomization to the date of first documented distant metastasis or date of first clinical and/or radiographic appearance of disseminated disease. ] [ Designated as safety issue: No ]
  • Biochemical failure by the Phoenix definition (PSA ≥ 2 ng/mL over the nadir PSA) [ Time Frame: From date of randomization to the date of first biochemical failure by phoenix definition within 5 years of randomization. ] [ Designated as safety issue: No ]
  • Incidence of "acute" adverse events as assessed by the Common Toxicity Criteria for Adverse Effects (CTCAE) current version [ Time Frame: From protocol treatment start date to the date of first occurrence of worst severity of the adverse event </= 30 days from completion of radiation therapy. ] [ Designated as safety issue: Yes ]
  • Time to "late" grade 3+ adverse events as assessed by CTCAE current version [ Time Frame: From protocol treatment start date to the date of the first late grade 3+ adverse event occurring more than 30 days after the completion of radiation therapy. ] [ Designated as safety issue: Yes ]
  • Prostate cancer-specific HRQOL change as measured by the EPIC-26 (bowel or urinary domain) [ Time Frame: Date when baseline EPIC-26 completed to 6 months post radiation therapy, 1 year post radiation therapy and 5 years post radiation therapy. ] [ Designated as safety issue: No ]
  • Fatigue status as measured by the Patient-Reported Outcome Measurement Information System (PROMIS) fatigue-domain change score [ Time Frame: From the date when the baseline PROMIS is completed to the last week of treatment. ] [ Designated as safety issue: No ]
  • Assessment and comparison of Quality Adjusted Life Years (QALYs) [ Time Frame: From the baseline QALYs assessment to the last week of radiation therapy (RT), 3 months post RT, 6 months post RT, 1 year post RT and 5 years post RT. ] [ Designated as safety issue: No ]

Estimated Enrollment: 2580
Study Start Date: July 2011
Estimated Primary Completion Date: July 2027 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients undergo high-dose radiotherapy of the prostate and seminal vesicles using intensity-modulated radiotherapy (IMRT)* or 3D-conformal radiation therapy (3D-CRT)* once daily, 5 days a week, for approximately 9 weeks. Patients may also undergo permanent prostate implant (PPI) brachytherapy or high-dose rate brachytherapy (I 125 or Pd 103 may be used as the radioisotope).
Radiation: radiation therapy
Undergo RT using IMRT or 3D-CRT
Experimental: Arm II
Patients undergo whole-pelvic radiotherapy (WPRT)* (3D-CRT or IMRT) once daily, 5 days a week, for approximately 9 weeks. Patients may also undergo brachytherapy as in arm I.
Radiation: Whole-pelvic radiotherapy (WPRT)
Undergo whole-pelvic radiotherapy (WPRT)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate- to high-risk for recurrence as determined by one of the following combinations:

    • Gleason score 7-10 + T1c-T2b (palpation) + prostate-specific antigen (PSA) < 50 ng/mL (includes intermediate- and high-risk patients)
    • Gleason score 6 + T2c-T4 (palpation) + PSA < 50 ng/mL OR
    • Gleason score 6 + >= 50% (positive) biopsies + PSA < 50 ng/ml
    • Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/mL Patients previously diagnosed with low risk prostate cancer undergoing active surveillance who are re-biopsied and found to have unfavorable intermediate risk disease or favorable high risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure.
  • History and/or physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration
  • Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal CT or MR), (but not by nodal sampling, or dissection) within 90 days prior to registration

    • Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm
    • Patients status post a negative lymph node dissection are not eligible
  • No evidence of bone metastases (M0) on bone scan within 120 days prior to registration (Na F PET/CT is an acceptable substitute)

    • Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis
  • Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 120 days prior to registration
  • Study entry PSA should not be obtained during the following time frames:

    • Ten-day period following prostate biopsy
    • Following initiation of hormonal therapy
    • Within 30 days after discontinuation of finasteride
    • Within 90 days after discontinuation of dutasteride

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin (Hgb) ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable)
  • No prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 3 years (1,095 days) and not in the pelvis

    • E.g., carcinoma in situ of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed
    • No prior hematological (e.g., leukemia, lymphoma, or myeloma) malignancy
    • No previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
    • No previous pelvic irradiation, prostate brachytherapy or bilateral orchiectomy
    • No previous hormonal therapy, such as LHRH agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate), estrogens (e.g., DES), or surgical castration (orchiectomy)
  • Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 45 days prior to the date of registration.
  • No severe, active co-morbidity, defined as any of the following:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • Transmural myocardial infarction within the last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects or severe liver dysfunction
    • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition

      • Protocol-specific requirements may also exclude immuno-compromised patients
      • HIV testing is not required for entry into this protocol
  • No patients who are sexually active and not willing/able to use medically acceptable forms of contraception
  • No prior allergic reaction to the hormones involved in this protocol

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer
  • No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
  • No prior hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate), estrogens (e.g., diethylstilbestrol (DES) ), or surgical castration (orchiectomy)
  • No prior pharmacologic androgen ablation for prostate cancer unless the onset of androgen ablation is ≤ 45 days prior to the date of registration
  • No finasteride within 30 days prior to registration
  • No dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration
  • No prior or concurrent cytotoxic chemotherapy for prostate cancer

    • Prior chemotherapy for a different cancer is allowable
  • No prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368588

  Show 150 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
NRG Oncology
Investigators
Principal Investigator: Mack Roach, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01368588     History of Changes
Other Study ID Numbers: RTOG-0924, CDR0000701128, NCI-2011-02674
Study First Received: June 7, 2011
Last Updated: November 13, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
adenocarcinoma of the prostate
stage I prostate cancer
stage IIA prostate cancer
stage IIB prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014