Phase 2 N=5 Treatment

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

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00714753 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2018

Primary outcome: Primary: Treatment Tolerance (Genitourinary [GU] or Gastrointestinal [GI] Adverse Events) — 3 events

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: brachytherapy (Radiation); hypofractionated radiation therapy (Radiation); image-guided radiation therapy (Radiation); intensity-modulated radiation therapy (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Mayo Clinic
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Tolerance (Genitourinary [GU] or Gastrointestinal [GI] Adverse Events)	3	—
SECONDARY Association Between Dose-volume Limitations for Organs at Risk and Rate and Severity of GU or GI Adverse Events	—	—
SECONDARY Patient Preference for a Second Treatment (a Second High Dose-rate Brachytherapy Session or an External Beam Radiotherapy Session)	—	—
SECONDARY Changes in Health-related Quality of Life Scores	—	—
SECONDARY Freedom From Biochemical and Clinical Failure	—	—
SECONDARY Freedom From Salvage Androgen Suppression Treatment	—	—

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.

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00714753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.