Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer - Full Text View

Purpose

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Radiation: stereotactic body radiation therapy	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I and II Study of Stereotactic Body Radiation Therapy (SBRT) for Low and Intermediate Risk Prostate Cancer (SBRT Prostate)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Maximum tolerated dose (MTD) or a dose of 50 Gy total (whichever comes first) [ Designated as safety issue: Yes ]
Late severe genitourinary (GU) and gastrointestinal (GI) toxicity defined as grade 3-5 toxicity occurring between 270-540 days (i.e., 9-18 months) from the start of the protocol treatment as assessed by CTCAE v3.0 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Acute severe GU and GI toxicity defined as grade 3-5 toxicity occurring prior to 270 days from the start of protocol treatment as assessed by CTCAE v3.0 [ Designated as safety issue: Yes ]
Non-GU and non-GI toxicity [ Designated as safety issue: Yes ]
Biochemical failure defined as a rise in the PSA level by more than 2 ng/mL above the lowest level (nadir) achieved after treatment [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Disease-specific survival [ Designated as safety issue: No ]
Clinical progression including local/regional and distant relapse [ Designated as safety issue: No ]

Estimated Enrollment:	97
Study Start Date:	July 2006
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To escalate the dose of stereotactic body radiotherapy (SBRT) to a tumoricidal dose without exceeding the maximum tolerated dose in patients with organ-confined prostate cancer. (Phase I)
To determine the late, severe grade 3-5 genitourinary and gastrointestinal toxicity occurring between 270-540 days (i.e., 9-18 months) from the start of the protocol treatment as assessed by CTCAE v3.0. (Phase II)

Secondary

To determine the dose-limiting toxicity of SBRT in these patients. (Phase I)
To determine the 2-year biochemical (PSA) control (freedom from PSA failure), disease-free and overall survival, local control, freedom from distant metastases, and the incidence of high-grade adverse events of any type in patients treated with this therapy in order to determine if the therapy is promising enough for further clinical investigation. (Phase II)

OUTLINE: This is a multicenter, phase I dose-escalation study followed by a phase II open-label study.

Phase I: Patients undergo 5 treatments of stereotactic body radiotherapy (SBRT).
Phase II: Patients undergo SBRT at the maximum tolerated dose as in phase I. After completion of study treatment, patients are followed at 1.5, 3, 6, 9, and 12 months, every 6 months for 5 years, and then once a year for years 5-10.

PROJECTED ACCRUAL: A total of 97 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the prostate
- Stage T1a, T1b, T1c disease
- Stage T2a or T2b
No direct evidence of regional or distant metastases
No T2c, T3, or T4 tumors
Gleason score ≤ 7
Must meet the following criteria:
- Prostate-specific antigen (PSA) ≤ 20 ng/mL prior to starting hormonal therapy (if given) for patients with a Gleason score of 2-6
- PSA ≤ 15 ng/mL prior to starting hormonal therapy (if given) for patients with a Gleason score of 7
- Risk of pelvic lymph node involvement < 20% according to Roach formula
Ultrasound-based volume estimation of the prostate gland ≤ 60 g

PATIENT CHARACTERISTICS:

Zubrod performance status 0-2
Fertile patients must use effective contraception
No prior invasive malignancy, except for nonmelanoma skin cancer, unless disease-free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are allowed)
No significant urinary obstructive symptoms
- American Urological Association (AUA) score of ≤ 15 (alpha blockers allowed)
No history of inflammatory colitis (including Crohn disease and ulcerative colitis)
No history of significant psychiatric illness
No severe, active comorbidity including any of the following:
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  - Laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
- AIDS (based on current CDC definition) or other immunocompromising condition
  - HIV testing is not required for entry into this protocol

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
More than 9 months since prior hormonal therapy as neoadjuvant therapy or to downsize the prostate gland
No prior pelvic radiotherapy
No prior chemotherapy or surgery for prostate cancer
No prior transurethral resection of the prostate (TURP) or cryotherapy to the prostate
No plans for other concurrent post-treatment, adjuvant, antineoplastic therapy including surgery, cryotherapy, conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy as part of the treatment for prostate cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547339

Locations

United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Recruiting
Dallas, Texas, United States, 75390
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097

Sponsors and Collaborators

Simmons Cancer Center

Investigators

Study Chair:

Robert D. Timmerman, MD

Simmons Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Regulatory Affairs Associate, University of Texas Southwestern Medical Center at Dallas
ClinicalTrials.gov Identifier:	NCT00547339 History of Changes
Other Study ID Numbers:	CDR0000571546, SCCC-062006-010, SCCC-0604122, UMN-2006UC048
Study First Received:	October 19, 2007
Last Updated:	February 18, 2011
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013