Status:
COMPLETED
Internal Radiation Therapy With or Without External-Beam Radiation Therapy in Treating Patients With Localized Prostate Cancer
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the t...
Detailed Description
OBJECTIVES: Primary * Evaluate the tolerability of 2 radiotherapeutic regimens (high dose-rate brachytherapy \[HDR\] with or without image-guided intensity-modulated hypofractionated external beam r...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate, meeting one of the following criteria:
- Low-risk disease (T1-T2a, Gleason score ≤ 6, and PSA \< 10 ng/mL)
- Low intermediate-risk disease (T1-T2c, Gleason score ≤ 6, and PSA \< 20 ng/mL OR T1-T2a, Gleason score 7, and PSA \< 10 ng/mL)
- No known nodal (N0 or NX) or distant (M0 or MX) metastases
- No pubic arch interference, as defined by either of the following:
- Maximum transrectal ultrasound-determined anterior-posterior (z-axis) dimension \< 4.3 cm
- No more than 25% prostate volume blocked (by pubic arch) on CT scan simulation at A10°I beam's eye view
- Prostate planimetry volume ≤ 60 cc as determined by step-section transrectal ultrasound
- American Urological Association voiding symptom index ≤ 12
- Peak uroflow rate (Q\_max) ≥ 12 cc/second
- Post-void ultrasound bladder residual volume ≤ 100 cc
- PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- Life expectancy ≥ 5 years
- WBC \> 2,000/μL
- Platelet count \> 100,000/μL
- PT \< 1.5 times upper limit of normal
- No diabetes mellitus associated with vascular ulcers or wound-healing problems
- No blood dyscrasias
- No inflammatory bowel disease
- No connective tissue disorder
- No other prior or concurrent invasive malignancy (except nonmelanoma skin cancer) or lymphomatous or hematological malignancy (except chronic lymphocytic leukemia/lymphoma) unless patient has been continually disease-free for ≥ 5 years
- No medical or psychiatric condition that would preclude giving informed consent or complying with study treatment
- Able to undergo anesthesia
- PRIOR CONCURRENT THERAPY:
- No prior transurethral resection of the prostate
- No prior prostatic cryoablation or high-intensity focused ultrasound
- No prior prostatectomy
- No prior prostatic enucleation
- No prior pelvic external beam radiotherapy
- No prior radionuclide prostate brachytherapy
- No prior hemi- or total hip arthroplasty
- Neoadjuvant androgen suppression therapy allowed provided it was initiated 2-6 months prior to study entry and its total duration is ≤ 6 months
- No concurrent anticoagulation therapy, including heparin or coumadin
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00714753
Start Date
August 1 2008
End Date
December 1 2013
Last Update
August 7 2019
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905