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A Phase II Study of Targeted Brachytherapy for Low Risk Prostate Cancer Patients


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

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Trial Information

A Phase II Study of Targeted Brachytherapy for Low Risk Prostate Cancer Patients


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Biochemical PSA control using the Phoenix definition of PSA nadir + 2

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Mitchell Kamrava

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

11-003235

NCT ID:

NCT01859689

Start Date:

March 2012

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Recurrent Prostate Cancer
  • Stage I Prostate Cancer
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

Name

Location
Jonsson Comprehensive Cancer Center Los Angeles, California  90095