Intensity Modulated Radiation Therapy with Stereotactic Radiosurgery Boost and Hormone Therapy in Treating Patients with Prostate Cancer

Status: Active

Description

This phase I trial studies intensity modulated radiation therapy (IMRT) with stereotactic radiosurgery boost and hormone therapy in treating patients with prostate cancer. Specialized radiation therapy, such as IMRT and stereotactic radiosurgery, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Androgen hormones can cause the growth of prostate cancer cells and antihormone therapy drugs, such as leuprolide acetate, goserelin acetate, and bicalutamide, may lessen the amount of androgens made by the body. Giving IMRT with stereotactic radiosurgery boost and androgen deprivation therapy may be an effective treatment for prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • 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) < 75 ng/ml (includes intermediate and high risk patients) * Gleason score 6 + T2c-T4 (palpation) or > 50% (positive) biopsies + PSA < 75 ng/ml * Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/ml
  • 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 computed tomography [CT] or magnetic resonance imaging [MRI]), (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 =< 2.0 cm
  • No evidence of bone metastases (M0) on bone scan within 90 days prior to registration
  • Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis
  • Baseline serum PSA value performed with an Food and Drug Administration (FDA)-approved assay (e.g., Abbott, Hybritech) within 12 weeks (90 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 0-2
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
  • Platelets >= 100,000 cells/mm^3
  • Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
  • Patient must be able to provide study specific informed consent prior to study entry

Exclusion Criteria

  • Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 2 years
  • Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
  • Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
  • Previous 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)
  • Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation is =< 60 days prior to the date of registration
  • Use of finasteride within 30 days prior to registration
  • Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration
  • Previous or concurrent cytotoxic chemotherapy for prostate cancer; note that prior chemotherapy for a different cancer is allowable
  • Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields
  • Severe, active co-morbidity, defined as follows: * 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 * Hepatic insufficiency resulting in clinical jaundice and/or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x upper limit of normal
  • Patients who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Prior allergic reaction to the hormones involved in this protocol
  • Patients status-post a negative lymph node dissection are not eligible

Locations & Contacts

California

Sacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Contact: Megan Eileen Daly
Phone: 916-734-5428
Email: megan.daly@ucdmc.ucdavis.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To assess the feasibility and safety of a treatment strategy incorporating whole pelvic IMRT followed by an stereotactic body radiation therapy (SBRT) (stereotactic radiosurgery [SRS]) boost to the prostate with neoadjuvant, concurrent, and adjuvant androgen deprivation for a total of 28 months for men with unfavorable intermediate or high risk localized prostate cancer.

SECONDARY OBJECTIVES:

I. To assess biochemical control at 24 months following the experimental treatment strategy by the “Phoenix definition”.

II. To assess toxicity of the experimental treatment approach as scored by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

III. To assess motion of the prostate during the protracted delivery of hypofractionated radiotherapy as assessed by implanted electromagnetic (EM) transponder beacons.

OUTLINE:

Beginning 2 months prior to start of IMRT, patients receive leuprolide acetate intramuscularly (IM) or goserelin acetate subcutaneously (SC) monthly for 28 months. Patients also receive bicalutamide orally (PO) daily for 6 months in the absence of disease progression or unacceptable toxicity. Patients undergo IMRT 5 days a week on weeks 8-13. Within 7 days following IMRT, patients undergo stereotactic radiosurgery boosts in 2 fractions.

After completion of study treatment, patients are followed up every 6 months for 3 years and then yearly for 2 years.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
University of California Davis Comprehensive Cancer Center

Principal Investigator
Megan Eileen Daly

Trial IDs

Primary ID CCRO025
Secondary IDs NCI-2014-01486, 421870
Clinicaltrials.gov ID NCT02064036