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RTOG 0815: Randomized Trial With or Without Short-Term Androgen Deprivation for Intermediate-Risk Prostate Cancer

Conditions

Prostate | Prostate Cancer

Trial Phase

Phase III

Trial Purpose and Description

Trial Purpose

The purpose of this study is to compare the effects of dose-escalated radiation therapy with or without hormone therapy on your prostate cancer. Prior studies have suggested possible advantages to the administration of hormonal therapy with radiation. However, those studies were performed with radiation techniques that do not match those commonly used in clinical practice today (that is, dose-escalated radiotherapy). Therefore, we will be testing to see if similar benefits for hormonal therapy are seen when used with current radiation therapy techniques.


Participation Guidelines

Age:
18 Years and older
Gender:
Male

Eligibility Criteria

Inclusion Criteria:

  • Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma, at intermediate risk for recurrence, within 180 days prior to registration as determined by having one or more of the following intermediate-risk features: Gleason Score 7 PSA >10 but &le20 Clinical Stage T2b-T2c. Patients previously diagnosed with low risk (Gleason score < 6, clinical stage < T2a, and PSA < 10) prostate cancer undergoing active surveillance who are re-biopsied and found to have intermediate risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure.
  • Clinically negative lymph nodes as established by imaging (pelvic +/- abdominal CT or MRI), nodal sampling, or dissection within 60 days prior to registration.
  • Patients with a single intermediate risk factor only do not require abdominopelvic imaging, but these studies may be obtained at the discretion of the treating physician. Patients with 2 or 3 risk factors are required to undergo pelvic +/- abdominal CT or MRI.
  • Patients with lymph nodes equivocal or questionable by imaging are eligible without biopsy if the nodes are &le1.5 cm any node larger than this on imaging will require negative biopsy for eligibility.
  • No evidence of bone metastases (M0) on bone scan within 60 days prior to registration.
  • Bone scan is not required for patients enrolled with a single intermediate risk factor only, but this scan may be obtained at the discretion of the treating physician. Patients with 2 or 3 risk factors will require a negative bone scan for eligibility.
  • Equivocal bone scan findings are allowed if plain film x-rays are negative for metastasis.
  • History/physical examination (to include, at a minimum, digital rectal examination of the prostate and examination of the skeletal system and abdomen, and formal comorbidity assessment via the ACE-27 instrument) within 60 days prior to registration. Note: The ACE-27 is posted on the 0815 protocol information page on the RTOG web site, http://www.rtog.org. Institutions may access a web-based Comorbidity Calculator at ttp://oto2.wustl.edu/clinepi/comorbid.html.
  • Zubrod Performance Status 0-1
  • Age &ge 18
  • Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 60 days prior to registration.
  • Study entry PSA must not be obtained during the following time frames: (1) 10-day period following prostate biopsy (2) following initiation of ADT (3) within 30 days after discontinuation of finasteride or (4) within 90 days after discontinuation of dutasteride.
  • For patients undergoing brachytherapy only: CBC/differential obtained within 60 days prior to registration, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) &ge 1,800 cells/mm3 Platelets &ge 100,000 cells/mm3 Hemoglobin &ge 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb &ge8.0 g/dl is acceptable.)
  • Patient must be able to provide study-specific informed consent prior to study entry.

Exclusion Criteria:

  • Patients with Gleason Score &ge 8 PSA > 20 OR Clinical Stage &ge T3 are ineligible for this trial.
  • Should findings of extracapsular extension or seminal vesicle invasion be noted on prostate MRI, this study, if used, will not render patients ineligible for accrual to this protocol. Primary tumor staging for eligibility purposes is to be based on palpable or core biopsy evidence only with respect to extracapsular extension or seminal vesicle involvement.
  • Patients with all three intermediate risk factors who also have &ge 50% of the number of their biopsy cores positive for cancer are ineligible for this trial.
  • Prior invasive malignancy (except non-melanomatous skin cancer) or hematological (e.g., leukemia, lymphoma, myeloma) malignancy unless disease free for a minimum of 5 years (prior diagnoses of carcinoma in situ are permitted).
  • Prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery for prostate cancer.
  • Prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy.
  • Use of finasteride within 30 days prior to registration.
  • Use of dutasteride within 90 days prior to registration.
  • Any patient undergoing brachytherapy must have transrectal ultrasound confirmation of prostate volume <60 cc, AUA score &le15 within 60 days of registration, and no history of prior transurethral resection of the prostate (TURP) prior TURP is permitted for patients who receive EBRT only).


3.2.10.2

Sponsor:
Radiation Therapy Oncology Group
Dates:
05/03/2013
Last Updated:
Study HIC#:
1210010957