Prostate Cancer Clinical Trial

Internal Radiation Therapy With or Without External-Beam Radiation Therapy in Treating Patients With Localized Prostate Cancer

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 tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase II trial is studying the side effects of internal radiation therapy when given with or without external-beam radiation therapy and to see how well it works in treating patients with localized prostate cancer.

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Full 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 radiotherapy [EBRT]), as measured by the Common Terminology Criteria for Adverse Events (CTCAE v3.0), in patients with localized prostate cancer.

Secondary

Identify any associations between dose-volume parameters for organs at risk and the rate and severity of genitourinary or gastrointestinal adverse events.
Evaluate patient preference with regard to selection of a second treatment (a second HDR brachytherapy session or an EBRT session).
Evaluate patient-reported health-related quality of life (HRQOL) as measured by validated HRQOL instruments for 5 years.
Describe the probability of freedom from biochemical and clinical failure.
Describe the probability of freedom from salvage androgen suppression.

OUTLINE: Patients undergo high dose-rate (HDR) brachytherapy (2 fractions ≥ 5 hours apart). Beginning 2-4 weeks after completion of the first HDR brachytherapy session, patients undergo either a second session of HDR brachytherapy (2 fractions ≥ 5 hours apart) OR image-guided intensity-modulated hypofractionated external beam radiotherapy once daily 5 days a week for 3 weeks.

Quality of life is assessed at baseline, prior to the second treatment session, at 1 and 6 months after completion of treatment, every 6 months for 3 years, and then annually for 2 years.

After completion of study treatment, patients are followed at 1 and 6 months, every 6 months for 3 years, and then annually for 2 years.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

5

Study ID:

NCT00714753

Recruitment Status:

Completed

Sponsor:

Mayo Clinic

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There is 1 Location for this study

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Mayo Clinic
Rochester Minnesota, 55905, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

5

Study ID:

NCT00714753

Recruitment Status:

Completed

Sponsor:


Mayo Clinic

How clear is this clinincal trial information?

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