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Internal Radiation Therapy in Treating Patients With Low-Risk Prostate Cancer

This study has been withdrawn prior to enrollment.
(no participants enrolled)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01859689
First Posted: May 22, 2013
Last Update Posted: January 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
  Purpose
This phase II trial studies how well internal radiation therapy works in treating patients with low-risk prostate cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells.

Condition Intervention Phase
Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Radiation: brachytherapy Radiation: image-guided radiation therapy Other: laboratory biomarker analysis Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Targeted Brachytherapy for Low Risk Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Biochemical PSA control using the Phoenix definition of PSA nadir + 2 [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Grade 3-5 acute toxicity genitourinary (GU) and gastrointestinal (GI) toxicity, graded based on NCI CTCAE v4.0 [ Time Frame: 3 months ]
  • Grade 3-5 late toxicity GU and GI toxicity, graded based on NCI CTCAE v4.0 [ Time Frame: 6 months ]
  • Changes in health related quality of life (HR-QOL) as determined by EPIC scores [ Time Frame: Up to 24 months ]
  • Changes in HR-QOL as determined by IIEF scores [ Time Frame: Up to 24 months ]
  • Changes in HR-QOL as determined by IPSS scores [ Time Frame: Up to 24 months ]

Enrollment: 0
Study Start Date: March 2012
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (image-guided HDR brachytherapy)
Patients undergo 3 fractions of image-guided HDR brachytherapy over 2 days.
Radiation: brachytherapy
Undergo image-guided HDR brachytherapy
Other Names:
  • low-LET implant therapy
  • radiation brachytherapy
  • therapy, low-LET implant
Radiation: image-guided radiation therapy
Undergo image-guided HDR brachytherapy
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine long term 5 year prostate specific cancer (PSA) biochemical control using the Phoenix definition of PSA nadir + 2 of targeted hemi-gland brachytherapy.

SECONDARY OBJECTIVES:

I. To assess acute and late toxicity outcomes following targeted brachytherapy according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

II. To determine changes from baseline in health-related quality of life indicators using the validated Expanded Prostate Cancer Index Composite (EPIC) questionnaire, International Index of Erectile Function (IIEF) questionnaire, and International Prostate Symptom Score (IPSS) questionnaire.

III. To assess the potential value of multiparametric magnetic resonance imaging, including dynamic contrast enhancement perfusion imaging and diffusion tensor neurovascular tactographic imaging in predicting the development of equivocal disease (ED) following radiation treatment.

OUTLINE:

Patients undergo 3 fractions of image-guided high-dose rate (HDR) brachytherapy over 2 days.

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
  • Unilateral prostate cancer as determined by prostate biopsy
  • Less than or equal to 3 positive biopsy cores
  • No biopsy core >= 50% positive for cancer
  • Karnofsky performance status (KPS) >= 70
  • At least a 12 core prostate biopsy; if this was not performed then it will be repeated here at University of California at Los Angeles (UCLA)
  • Artemis guided biopsy of any suspicious target lesions as identified on multiparametric (mp)-magnetic resonance imaging (MRI)
  • Clinical stage T1c or T2a
  • PSA < 10 ng/ml
  • Gleason score 3+3=6

Exclusion Criteria:

  • Patients who have previously received radiation therapy to the pelvis
  • Refusal to sign the informed consent
  • Patients who are participating in a concurrent treatment protocol
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859689


Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Mitchell Kamrava Jonsson Comprehensive Cancer Center
  More Information

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01859689     History of Changes
Other Study ID Numbers: 11-003235
NCI-2013-00647 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: April 4, 2013
First Posted: May 22, 2013
Last Update Posted: January 29, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type


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