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Study of Hypofractionated Intensity Modulated External Beam Therapy for the Treatment of Patients With Adenocarcinoma of the Prostate


N/A
N/A
N/A
Open (Enrolling)
Male
Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer

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Trial Information

Study of Hypofractionated Intensity Modulated External Beam Therapy for the Treatment of Patients With Adenocarcinoma of the Prostate


PRIMARY OBJECTIVES:

I. To demonstrate that patients can safely receive IMRT teletherapy using the proposed IMRT
fractionation schedule without experiencing a treatment limiting toxicity.

SECONDARY OBJECTIVES:

I. To assess treatment efficacy through the surrogate measures of PSA nadir and biochemical
failure-free survival.

OUTLINE: Patients undergo hypofractionated intensity modulated radiotherapy once daily, 5
days a week, for 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients with intermediate- and high-risk disease may also receive concurrent and adjuvant
or long-term androgen deprivation therapy for up to 36 months. After completion of study
treatment, patients are followed at 4-6 weeks, every 4 months for 3 years, every 6 months
for 2 years, and then annually until year 5.


Inclusion Criteria:



- Patients with biopsy-proven adenocarcinoma of the prostate are eligible for protocol
enrollment when the following criteria are met; patients must have low, intermediate
or high-risk adenocarcinoma of the prostate, as defined by the National Comprehensive
Cancer Network (NCCN) criteria

- A diagnostic CT scan of the abdomen and pelvis will be obtained to rule out regional
disease (maximum of 60 days prior to registration) for high-risk patients only

- A bone scan showing no evidence of metastatic disease is also required for patients
whose prostate-specific antigen (PSA) is greater than 20 ng/ml, Gleason's sum is
greater than 7, or T-stage is greater than T2b

- Alkaline phosphatase within 1.5 x upper limit of normal (ULN) is required for all
patients beginning hormone therapy

- AST within 1.5 x ULN is required for all patients beginning hormone therapy

- Bilirubin within 1.5 x ULN is required for all patients beginning hormone therapy

- Karnofsky Performance score >= 80

- Prior to registration, patients having received no more than three months treatment
with anti-androgen, luteinizing hormone-releasing hormone (LHRH) agonist, or a
combination of the two remain eligible for protocol treatment; the qualifying PSA for
these patients will be the value recorded prior to the initiation of the hormone
therapy

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 five years of the
initiation of protocol treatment

- Patients with a history of pelvic irradiation for any reason

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) v3 criteria

Outcome Time Frame:

At 2 years

Safety Issue:

Yes

Principal Investigator

Michael G. Chang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Commonwealth University

Authority:

United States: Institutional Review Board

Study ID:

MCC-12870

NCT ID:

NCT01117935

Start Date:

May 2010

Completion Date:

August 2018

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Stage I Prostate Cancer
  • Stage II Prostate Cancer
  • Stage III Prostate Cancer
  • Stage IV Prostate Cancer
  • IMRT
  • prostate cancer
  • radiation therapy
  • external beam
  • recurrent prostate cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

Name

Location

Virginia Commonwealth UniversityRichmond, Virginia  
Hunter Holmes McGuire Veterans Administration Medical CenterRichmond, Virginia  23249