Prostate CancerPhase 1/2NCT00547339
Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
A Phase 1/2 study testing stereotactic body radiation therapy (SBRT)- 45 Gy, stereotactic body radiation therapy (SBRT) - 47.5 Gy and stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1) in people with Prostate Cancer, run by University of Texas Southwestern Medical Center at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- stereotactic body radiation therapy (SBRT)- 45 Gy, stereotactic body radiation therapy (SBRT) - 47.5 Gy and stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2006to 28 Nov 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, 80045
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
University of Minnesota Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
MD Anderson Cancer Center Orlando Florida
Orlando, Florida, 32806
Prairie Lakes Cancer Center
Watertown, South Dakota, 57201
About this study
Official title: A Phase I and II Study of Stereotactic Body Radiation Therapy (SBRT) for Low and Intermediate Risk Prostate Cancer (SBRT Prostate)
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- stereotactic body radiation therapy (SBRT)- 45 Gy, stereotactic body radiation therapy (SBRT) - 47.5 Gy, stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1), stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2)
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic body radiation therapy (SBRT)- 45 GyRadiation
Dose of SBRT - 45 Gray (Gy) in five fractions
stereotactic body radiation therapy (SBRT) - 47.5 GyRadiation
Also called Dose of SBRT - 47.5 Gy in five fractions
Dose of SBRT - 47.5 Gray (Gy) in five fractions
stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1)Radiation
Also called Dose of SBRT - 50 Gray (Gy) in five fractions
stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2)Radiation
Also called Dose of SBRT - 50 Gray (Gy) in five fractions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Radiation: stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 18 months
Secondary outcomes (8)
GU Toxicity (Only Phase 2)
To determine acute severe GU toxicity is defined as grade 3-5 occurring prior to 270 days from the start of the 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.
Measured: 9 months from start of treatment
GI Toxicity
To determine acute severe GI toxicity is defined as grade 3-5 occurring prior to 270 days from the start of the 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.
Measured: 9 months from start of treatment
Non-GU Toxicity
To determine non-GU (genitourinary) toxicity is defined as grade 3-5. 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.
Measured: 60 months
Non-GI Toxicity
To determine non-GI (gastrointestinal) toxicity is defined as grade 3-5. 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.
Measured: 60 months
Freedom From Biochemical Failure
Biochemical failure RTOG (Radiation Therapy Oncology Group)-ASTRO (American Society for Therapeutic Radiology and Oncology) definition (also known as Phoenix definition). Thus, when the PSA rises by more than 2 ng/ml above the lowest level (nadir) achieved after treatment, biochemical failure has occurred and the date of the failure is recorded at the time the nadir plus 2 ng/ml level is reached.
Measured: 36 months
Overall Survival
The survival time will be measured from the date of accession to the date of death.
Measured: 60 months
Disease Specific Survival
Disease-Specific Survival Disease-specific survival will be measured from the date of study entry to the date of death due to prostate cancer as the percentage of participants who survived the prostrate cancer disease.
Measured: 60 months
Clinical Progression Including Local/Regional and Distant Relapse
Clinical progression including local/regional and distant relapse is measured using Kaplan-Meier method
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2007 (estimated)
- Study startJul 2006
- Primary completion20 Jul 2014
- Study completion28 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Timmerman, University of Texas Southwestern Medical Center
- Investigators
- Robert D. Timmerman, MD, Study chair, Simmons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547339
- Sponsor's protocol ID
- SCCC-0604122; STU 072010-019
- Other IDs
- SCCC-062006-010, CDR0000571546, UMN-2006UC048
- Status last verified
- Dec 2022
- First submitted
- 19 Oct 2007
- Last updated
- 7 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I and II Study of Stereotactic Body Radiation Therapy (SBRT) for Low and Intermediate Risk Prostate Cancer (SBRT Prostate)
- ClinicalTrials.gov ID
- NCT00547339
- Acronym / sponsor ID
- SCCC-0604122; STU 072010-019
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jul 2006 (actual)
- Primary completion
- 20 Jul 2014 (actual)
- Study completion
- 28 Nov 2022 (actual)
- First posted
- 22 Oct 2007 (estimated)
- Results
- Posted 24 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Stereotactic Body Radiation Therapy (SBRT) 45 Gy | Experimental | Radiation: stereotactic body radiation therapy (SBRT)- 45 GyThe Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated - 45 Gy |
| Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 47.5 Gy | Experimental | Radiation: stereotactic body radiation therapy (SBRT) - 47.5 GyThe Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated- 47.5 Gy |
| Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy | Experimental | Radiation: stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1)The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated- 50 Gy |
| Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy | Experimental | Radiation: stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2)The dose of SBRT is escalated - 50 Gy in Phase 2 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stereotactic body radiation therapy (SBRT)- 45 GyDose of SBRT - 45 Gray (Gy) in five fractions | Radiation | Phase 1: Stereotactic Body Radiation Therapy (SBRT) 45 Gy |
| stereotactic body radiation therapy (SBRT) - 47.5 GyAlso: Dose of SBRT - 47.5 Gy in five fractionsDose of SBRT - 47.5 Gray (Gy) in five fractions | Radiation | Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 47.5 Gy |
| stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1)Also: Dose of SBRT - 50 Gray (Gy) in five fractions | Radiation | Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy |
| stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2)Also: Dose of SBRT - 50 Gray (Gy) in five fractions | Radiation | Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy |
Primary outcome
Number of Participants With Dose Limiting Toxicity (Phase 1 Only)
Time frame: 90 days after start of treatment
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)
No. of Late Severe GU Toxicity (for Phase 2 Only)
Time frame: 18 months
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.
No. of Late Severe GI Toxicity (for Phase 2 Only)
Time frame: 18 months
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.
8 secondary outcomes
GU Toxicity (Only Phase 2)
Time frame: 9 months from start of treatment
GI Toxicity
Time frame: 9 months from start of treatment
Non-GU Toxicity
Time frame: 60 months
Non-GI Toxicity
Time frame: 60 months
Freedom From Biochemical Failure
Time frame: 36 months
Overall Survival
Time frame: 60 months
Disease Specific Survival
Time frame: 60 months
Clinical Progression Including Local/Regional and Distant Relapse
Time frame: 60 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D. Timmerman, MD study chair
Simmons Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing stereotactic body radiation therapy (SBRT)- 45 Gy, stereotactic body radiation therapy (SBRT) - 47.5 Gy and stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1) in people with Prostate Cancer, run by University of Texas Southwestern Medical Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose Limiting Toxicity (Phase 1 Only) (time frame: 90 days after start of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.