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Study of 4-Fraction Split-Course Stereotactic Ablative Radiation Therapy of the Treatment of Patients With Low and Low-Intermediate Risk Adenocarcinoma of the Prostate


N/A
18 Years
N/A
Open (Enrolling)
Both
Prostate Adenocarcinoma, Stage I Prostate Cancer

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Trial Information

Study of 4-Fraction Split-Course Stereotactic Ablative Radiation Therapy of the Treatment of Patients With Low and Low-Intermediate Risk Adenocarcinoma of the Prostate


PRIMARY OBJECTIVES:

I. To evaluate, in terms of late toxicity, the safety of stereotactic radiation therapy
using the proposed fractionation schedule.

SECONDARY OBJECTIVES:

I. To evaluate, in terms of acute toxicity, the safety of stereotactic radiation therapy
using the proposed fractionation schedule.

II. To determine stereotactic treatment efficacy through biochemical failure (Phoenix
criteria).

III. To determine the protocol completion rate.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo standard daily fractions of stereotactic body radiation therapy
(SBRT) over 7-8.5 weeks.


Inclusion Criteria:



- Patients must have low or low-intermediate risk adenocarcinoma of the prostate as
defined by:

- Histopathology score (Gleason sum) =< 6, and T-stage (per current American Joint
Committee on Cancer [AJCC] staging criteria): T1c-T2a, and prostate-specific
antigen (PSA) < 10; or

- Histopathology score (Gleason sum) 3+4 = 7 in =< 2 cores, and =< 30% involvement
of any core, and T-stage (per current AJCC staging criteria): T1c, and PSA < 10

- No perineural or lymphovascular invasion present in biopsy specimen

- Charlson index of comorbidity score =< 4

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients with history of inflammatory bowel disease, or who require steroid or
cytotoxic therapy for collagen vascular disease

- Patients with a history of cancer other than skin cancer within 5 years of the
initiation of protocol treatment

- Patients with a history of pelvic irradiation for any reason

- Life expectancy < 10 years - Prior treatment with an anti-androgen, luteinizing
hormone-releasing hormone (LHRH) agonist, or a combination of the two

- Prior radiation therapy, brachytherapy, or cryotherapy

- Prior surgical procedure involving peri-rectal and peri-prostatic area

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Late toxicity greater than or equal to grade 2 as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria

Outcome Description:

Will be tested using a continuity corrected chi-square test

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Mitchell Anscher, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Commonwealth University

Authority:

United States: Institutional Review Board

Study ID:

MCC-14712

NCT ID:

NCT01737151

Start Date:

March 2013

Completion Date:

December 2016

Related Keywords:

  • Prostate Adenocarcinoma
  • Stage I Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

Name

Location
Virginia Commonwealth University, Massey Cancer Center Richmond, Virginia  23298