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

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Radiation: hypofractionated radiation therapy; Radiation: intensity-modulated radiation therapy; Radiation: image-guided radiation therapy; Radiation: brachytherapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00714753

P30CA015083 (U.S. NIH Grant/Contract)

CDR0000600446

MC0652 (Other Identifier)

08-001451 (Other Identifier)

Details and patient eligibility

About

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.

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.

Enrollment: 5 patients

Sex: Male

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Intervention Group

Experimental group

Description:

Protocol treatment consists of either two high dose-rate (HDR) brachytherapy implantation sessions or one HDR brachytherapy session followed by external beam radiotherapy (EBRT). Each HDR session consists of two 9.5Gy fractions. After the first HDR session of two fractions, patients express a preference for: (1) a second HDR brachytherapy implantation session, or (2) EBRT. The second HDR session or EBRT will begin 2-4 weeks after the first HDR brachytherapy session.

Treatment:

Radiation: brachytherapy

Radiation: image-guided radiation therapy

Radiation: intensity-modulated radiation therapy

Radiation: hypofractionated radiation therapy