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

This study has been withdrawn prior to enrollment.
(no participants enrolled)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01859689
First received: April 4, 2013
Last updated: January 27, 2014
Last verified: January 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
  • Grade 3-5 late toxicity GU and GI toxicity, graded based on NCI CTCAE v4.0 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Changes in health related quality of life (HR-QOL) as determined by EPIC scores [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Changes in HR-QOL as determined by IIEF scores [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Changes in HR-QOL as determined by IPSS scores [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01859689

Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Mitchell Kamrava Jonsson Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01859689     History of Changes
Other Study ID Numbers: 11-003235, NCI-2013-00647
Study First Received: April 4, 2013
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

ClinicalTrials.gov processed this record on July 28, 2014