This study is in progress, not accepting new patients

Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

a study on Prostate Cancer Androgen Deprivation Therapy

Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at Merced, California and other locations
Dates
study started
study ends around

Description

Summary

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.

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

Details

OBJECTIVES:

Primary

  • Demonstrate that prophylactic, neoadjuvant androgen-deprivation therapy (NADT) combined with whole-pelvic radiation therapy (WPRT) improves overall survival (OS) compared with NADT combined with prostate and seminal vesicle radiation therapy (RT), with both arms receiving a high-dose prostate boost delivered by intensity-modulated RT (IMRT), external-beam RT (EBRT), high-dose-rate (HDR) brachytherapy, or permanent prostate implant (PPI).

Secondary

  • Demonstrate that prophylactic WPRT improves biochemical control.
  • Determine the distant metastasis (DM)-free survival.
  • Determine the cause-specific survival (CSS).
  • Compare acute and late treatment-adverse events between patients receiving NADT and WPRT versus NADT, P, and SV RT.
  • Determine whether health-related quality of life (HRQOL), as measured by the Expanded Prostate Cancer Index Composite (EPIC), significantly worsens with increasing aggressiveness of treatment (i.e., Arm 2, NADT + WPRT).
  • Determine whether more aggressive treatment (Arm 2, NADT + WPRT) is associated with a greater increase in fatigue (PROMIS Fatigue Short Form) from baseline to last week of treatment, and a greater increase in circulating inflammatory markers (IL-1, IL-1ra, IL-6, tumor necrosis factor (TNF)-alpha, and C-reactive protein).
  • Demonstrate an incremental gain in OS and CSS with more aggressive therapy that outweighs any detriments in the primary generic domains of HRQOL (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
  • Determine whether changes in fatigue from baseline to the next three time points (week prior to RT, last week of treatment, and 3 months after treatment) are associated with changes in circulating cytokines, mood, sleep, and daily activities across the same time points.
  • Collect paraffin-embedded tissue blocks, plasma, whole blood, and urine for planned and future translational research analyses.

OUTLINE: This is a multicenter study. Patients are stratified according to moderate- to high-risk groups as listed in the Disease Characteristics of this abstract, type of radiotherapy boost (IMRT vs brachytherapy [Low-dose rate (LDR) using PPI or HDR]), and duration of androgen-deprivation therapy (short-term [4-6 months] vs long-term [32 months]). Patients are randomized to 1 of 2 treatment arms.

All patients receive neoadjuvant androgen-deprivation therapy comprising bicalutamide orally (PO) once daily or flutamide PO thrice daily for 4-6 months, and luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy comprising leuprolide acetate, goserelin acetate, buserelin, triptorelin, or degarelix subcutaneously (SC) or intramuscularly (IM) every 1 to 3 months beginning 2 months prior to radiotherapy and continuing for 4-6 or 32 months.

Radiotherapy begins within 8 weeks after beginning LHRH agonist/antagonist injection.

Patients may undergo blood and urine sample collection for correlative studies. Primary tumor tissue samples may also be collected.

Patients may complete the Expanded Prostate Cancer Index Composite (EPIC), the PROMIS-Fatigue Short Form, and the EuroQol (EQ-5D) quality-of-life (QOL) questionnaires at baseline and periodically during treatment. Patients who participate in the QOL portion of the study must also agree to periodic blood collection.

After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 3 years, and then yearly thereafter.

Keywords

Prostate Cancer, adenocarcinoma of the prostate, stage I prostate cancer, stage IIA prostate cancer, stage IIB prostate cancer, stage III prostate cancer, Prostatic Neoplasms, Conformal Radiotherapy, Intensity-Modulated Radiotherapy, Brachytherapy, Androgen Antagonists, Gonadotropin-Releasing Hormone, three-dimensional conformal radiotherapy, intensity modulated radiotherapy, Anti-androgen, luteinizing hormone-releasing hormone (LHRH) agonist or antagonist

Eligibility

For males ages 18 years and up

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) + PSA < 50 ng/ml (includes intermediate and high risk patients);

  • Gleason score 6 + T2c-T4 (palpation) + PSA < 50 ng/ml

    -ORGleason 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/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 ± 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.

    *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: (1) 10- day period following prostate biopsy; (2) following initiation of hormonal therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days after discontinuation of dutasteride.
    • Zubrod Performance Status 0-1(unless otherwise specified);
    • Age ≥ 18;
    • CBC/differential obtained within 60 days prior to registration on study, with adequate bone marrow function defined as follows:
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3;
  • Platelets ≥ 100,000 cells/mm3;
  • Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.);
    • Patient must be able to provide study specific informed consent prior to study entry.

Locations

  • Mercy UC Davis Cancer Center
    Merced California 95340 United States
  • University of California Davis Comprehensive Cancer Center
    Sacramento California 95817 United States
  • Mercy Cancer Center - Sacramento
    Sacramento California 95816 United States
  • Sutter Medical Center Sacramento
    Sacramento California 95816 United States
  • Sutter Cancer Centers Radiation Oncology Services-Vacaville
    Vacaville California 95687 United States
  • South Sacramento Cancer Center
    Sacramento California 95823 United States
  • Mercy San Juan Medical Center
    Carmichael California 95608 United States
  • Kaiser Permanente-Rancho Cordova Cancer Center
    Rancho Cordova California 95670 United States
  • The Permanente Medical Group-Roseville Radiation Oncology
    Roseville California 95678 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Radiation Therapy Oncology Group
ID
NCT01368588
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 2590 people participating
Last Updated