Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer

NCT00547339 | Completed Phase 1 Results DMC

• 4 other identifiers: SCCC-0604122; STU 072010-019SCCC-062006-010CDR0000571546UMN-2006UC048
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Dose Limiting Toxicity (Phase 1 Only)

  Dose-limiting toxicity (DLT) was defined as grade 3 to 5 GI, genito urinary, sexual, or neurologic toxicity attributed to therapy occurring within 90 days of registration using Common Terminology Criteria of Adverse Events(version 3)

  90 days after start of treatment

• No. of Late Severe GU Toxicity (for Phase 2 Only)

  To determine late severe GU toxicity defined as grade 3-5 occurring between 279-540 days (i.e., 9-18 months) from the start of protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.

  18 months

• No. of Late Severe GI Toxicity (for Phase 2 Only)

  To determine late severe GI toxicity defined as grade 3-5 occurring between 279-540 days (i.e., 9-18 months) from the start of protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.

  18 months

Secondary Outcomes (8)

• GU Toxicity (Only Phase 2)

  9 months from start of treatment

• GI Toxicity

  9 months from start of treatment

• Non-GU Toxicity

  60 months

• Non-GI Toxicity

  60 months

• Freedom From Biochemical Failure

  36 months

Study Arms (4)

Phase 1: Stereotactic Body Radiation Therapy (SBRT) 45 Gy

EXPERIMENTAL

The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated - 45 Gy

Radiation: stereotactic body radiation therapy (SBRT)- 45 Gy

Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 47.5 Gy

EXPERIMENTAL

The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated- 47.5 Gy

Radiation: stereotactic body radiation therapy (SBRT) - 47.5 Gy

Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy

EXPERIMENTAL

The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated- 50 Gy

Radiation: stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1)

Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy

EXPERIMENTAL

The dose of SBRT is escalated - 50 Gy in Phase 2

Radiation: stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2)

Interventions

stereotactic body radiation therapy (SBRT)- 45 Gy RADIATION

Dose of SBRT - 45 Gray (Gy) in five fractions

Phase 1: Stereotactic Body Radiation Therapy (SBRT) 45 Gy

stereotactic body radiation therapy (SBRT) - 47.5 Gy RADIATION

Dose of SBRT - 47.5 Gray (Gy) in five fractions

Also known as: Dose of SBRT - 47.5 Gy in five fractions

Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 47.5 Gy

stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1) RADIATION

Also known as: Dose of SBRT - 50 Gray (Gy) in five fractions

Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy

stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2) RADIATION

Also known as: Dose of SBRT - 50 Gray (Gy) in five fractions

Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (5)

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, 80045, United States

Location

MD Anderson Cancer Center Orlando Florida

Orlando, Florida, 32806, United States

Location

University of Minnesota Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Prairie Lakes Cancer Center

Watertown, South Dakota, 57201, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Robert Timmerman
• Organization: University of Texas Southwestern Medical Center Dallas

Robert.Timmerman@UTSouthwestern.edu

214-645-8525

Study Officials

• Robert D. Timmerman, MD

  Simmons Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 19, 2007
• First Posted: October 22, 2007
• Study Start: July 1, 2006
• Primary Completion: July 20, 2014
• Study Completion: November 28, 2022
• Last Updated: December 7, 2022
• Results First Posted: March 24, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)