Clinical trial NCT00714753: Internal Radiation Therapy With or Without External-Beam Radiation Therapy in Treating Patients With Localized Prostate Cancer
Official title: Pilot Evaluation of High Dose-Rate Brachytherapy ± Image-Guided Intensity Modulated Hypofractionated External Radiotherapy for Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: stage I prostate cancer
stage II prostate cancer
adenocarcinoma of the prostate
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-07-14
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 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.

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

Primary outcomes:
measure: Treatment Tolerance (Genitourinary [GU] or Gastrointestinal [GI] Adverse Events)
timeFrame: From baseline to 3 years after registration
Secondary outcomes:
measure: Association Between Dose-volume Limitations for Organs at Risk and Rate and Severity of GU or GI Adverse Events
timeFrame: From baseline to 5 years after registration
measure: Patient Preference for a Second Treatment (a Second High Dose-rate Brachytherapy Session or an External Beam Radiotherapy Session)
timeFrame: From baseline until the end of the first treatment
measure: Changes in Health-related Quality of Life Scores
timeFrame: From baseline to 5 years after registration
measure: Freedom From Biochemical and Clinical Failure
timeFrame: From baseline to 5 years after registration
measure: Freedom From Salvage Androgen Suppression Treatment
timeFrame: From baseline to 5 years after registration
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Thomas M. Pisansky, MD
role: PRINCIPAL_INVESTIGATOR
References: