Whole-Pelvic Radiotherapy With a Stereotactic Body Radiotherapy Boost and Long-Term Androgen Deprivation for Unfavorable-Intermediate and High Risk Localized Adenocarcinoma of the Prostate.
Condition: Adenocarcinoma of the Prostate
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT02064036
Sponsor: University of California, Davis
- Age: minimum 18 Years maximum N/A
- Gender: Male
- Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence
- 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 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 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
- Complete blood count (CBC)/differential obtained within 2 weeks (14 days) prior to registration on study, with adequate bone marrow function
- Patient must be able to provide study specific informed consent prior to study entry.
- 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
- 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. See Section 3.2.
- Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields
- Severe, active co-morbidity including heart issues, infection and liver problems
- 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
View trial on ClinicalTrials.gov