Trial Search Results

High-Dose Brachytherapy in Treating Patients With Prostate Cancer

This phase I/II trial studies the side effects and how well high-dose brachytherapy works in treating patients with prostate cancer that has not spread to other parts of the body. Brachytherapy is a type of radiation therapy in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor and may be a better treatment in patients with prostate cancer.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Radiation: Internal Radiation Therapy
  • Drug: Bicalutamide
  • Drug: Leuprolide Acetate
  • Drug: Goserelin Acetate
  • Drug: Triptorelin Pamoate
  • Drug: Degarelix
  • Other: Laboratory Biomarker Analysis
  • Other: Quality-of-Life Assessment

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - Documented pathologic confirmation of prostate adenocarcinoma

   - Clinical T-classification T1-3

   - PSA < 150 ng/mL

   - Gleason score 6-10

   - No evidence of distant metastasis based on a history/physical examination (to include
   at least digital rectal examination of the prostate and assessment of the abdomen and
   skeletal system)

   - Clinically negative lymph nodes as established by abdomino-pelvic CT, no more than 90
   days prior toregistration; CT only for clinical classification of > T3- (with contrast
   if renal function is acceptable; a non-contrast CT is permitted if the patient is not
   a candidate for contrast) or magnetic resonance imaging (MRI), nodal sampling, or
   dissection. Patients with lymph nodes equivocal or questionable by imaging are
   eligible if the nodes are <1 cm in short axis.

   - No evidence of bone metastases (M0) on bone scan (sodium fluoride [NaF] positron
   emission tomography [PET]/CT is an acceptable substitute) performed no more than 120
   days prior to registration; equivocal bone scan findings are allowed if plain films
   and/or MRI are negative for definite metastases

   - American Urological Association Symptom Index (AUA SI) =< 15

   - No prior transurethral resection of prostate (TURP)

Exclusion Criteria:

   - Clinical T4 disease

   - N1 patients are ineligible, as are those with pelvic lymph nodes >= 1 cm in short axis
   diameter, defined as pathologically enlarged per Response Evaluation Criteria in Solid
   Tumors (RECIST) 1.1, by CT or MRI of the abdomen and pelvis, unless the enlarged lymph
   nodes are negative after sampling

   - PSA >= 150 ng/mL

   - AUA SI > 15

   - History of radical prostatectomy, external beam radiotherapy (EBRT), or BT for
   prostate cancer

   - Prior invasive malignancy (except non-melanoma skin cancer), unless disease-free for
   at least 3 years; no patient with a history of pelvic or hematologic malignancy is
   eligible, regardless of disease-free interval

   - Previous chemotherapy for any malignancy, if given within three years of registration

   - Past history of other investigational agents

   - History of rectal surgery

   - History of rectal fistula

   - History of inflammatory bowel disease

   - Severe, active co-morbidity, defined as follows:

      - Unstable angina and/or congestive heart failure requiring hospitalization within
      the last six months

      - Transmural myocardial infarction within the last six 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

      - Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C liver
      disease

      - Human immunodeficiency virus (HIV)-positivity with cluster of differentiation
      (CD)4 count < 200 cells/microliter; note that HIV-positive patients are eligible,
      provided they are under treatment with highly active antiretroviral therapy
      (HAART) and have a CD4 count >= 200 cells/microliter no more than 30 days prior
      to registration; note also that HIV testing is not required for eligibility on
      this protocol

   - End-stage renal disease (i.e., any patient requiring or advised to undergo dialysis)

   - Prior allergic reaction to the study drug(s) involved in this protocol

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

Male

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Matt Morales
650-721-4072
Recruiting