Prostate CancerNCT00977860
Hypofractionated SBRT For Prostate Cancer
A study testing Stereotactic Body Radiation Therapy in people with Prostate Cancer, run by Adam Olson at 1 site in United States.
Trial summary
The purpose of this study is to determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher gastrointestinal and genitourinary toxicity observed during a 24 month follow up and to estimate the rate of biochemical Disease-Free Survival, Phoenix and American Society for… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2010to 8 Jul 2022
- Phase
- Interventional
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven prostate adenocarcinoma
- Gleason score 2-7
- Biopsy within one year of date of registration
- Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)
- T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI)
- M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases.
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- PSA ≤ 20 ng/dL
- Patients belonging in one of the following risk groups:
- Low: CS T1b-T2a and Gleason 2-6 and PSA ≤ 10, or
- Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10, or CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/dL, or Gleason 7 and PSA ≤ 10 ng/dL
- Prostate volume: ≤ 100 cc
- Determined using: volume = π/6 x length x height x width
- Measurement from CT or ultrasound ≤90 days prior to registration.
- ECOG performance status 0-1
- Completion of patient questionnaires:FACT-G questionnaire, AUA questionnaire, EPIC-26 questionnaire, SHIM questionnaire, Utilization of Sexual Medications/Devices questionnaire
- Consent signed.
Who cannot join
- Prior prostatectomy or cryotherapy of the prostate
- Prior radiotherapy to the prostate or lower pelvis
- Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
- Chemotherapy for a malignancy in the last 5 years.
- History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.
- Hormone ablation for two months prior to enrollment, or during treat
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Hillman Cancer Center - Shadyside Radiation Oncology
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Prospective Evaluation Of Hypofractionated Stereotactic Body Radiotherapy For Low And Intermediate Risk Prostate Cancer
The purpose of this study is to determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher gastrointestinal and genitourinary toxicity observed during a 24 month follow up and to estimate the rate of biochemical Disease-Free Survival, Phoenix and American Society for Therapeutic Radiology and Oncology definitions, at 2 years following hypofractionated stereotactic body radiation therapy for low and intermediate risk prostate cancer.
Read the detailed description
Radiosurgery should be ideal for treating prostate cancer because:
- targeting accuracy for static targets is excellent, with an error of about 1mm,
- it can adjust for intra-fractional organ motion, reducing the volume of the target PTV and therefore the dose to surrounding organs,
- by using over one-hundred non-conplanar beams, the dose gradient between the prostate and surrounding tissues may be superior to that achieved with conventional linear accelerators,
- the radiobiology of prostate cancer may favor large dose per fractions.
- Conditions
- Prostate Cancer
- Being tested
- Stereotactic Body Radiation Therapy
- Keywords
- Prostate, Stereotactic, Radiosurgery
- 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 TherapyRadiation
Also called CyberKnife, Trilogy, True Beam, Radiosurgery
36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period
| Study group | Role | What they receive |
|---|---|---|
| SBRT | Other | Not described Receives: Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Acute Grade 3 or Higher GI and GU Toxicities
Number of patients experiencing acute grade 3 or higher GI and GU toxicities. Acute toxicities are those occurring within 90 days of start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0.
Measured: Up to 90 days
Rate of Late Grade 3 or Higher GI and GU Toxicities
Number of patients experiencing late grade 3 or higher GI and GU toxicities. Late toxicities are those occurring after 90 days post start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0.
Measured: After 90 days post-treatment, up to 5 years per patient
Biochemical Disease-Free Survival Rate (bDFS)
Biochemical Disease-Free Survival (bDFS) as defined by Phoenix and ASTRO. Biochemical progression-free survival events were defined as PSA of ≥ 0.4 ng/mL following postoperative radiotherapy, PSA > 2.0 ng/mL at any time, clinical progression, initiation of non-protocol hormone therapy, and death from any cause.
Measured: Up to 5 years
Secondary outcomes (5)
Rate of Local Failure
Proportion of patients with 'local failure', which is defined as clinical evidence local recurrence. Clinical failure includes a palpable abnormality that has increased in size, failure of regression of a palpable abnormality, or redevelopment of a prostate abnormality after complete response, further confirmed by prostate biopsy.
Measured: Up to 5 years
Rate of Distant Failure
Proportion of patients with 'distant failure' (includes regional failure) which is defined as documented clinically via bone scan, CT or other imaging study that shows metastatic disease (disease located distant from the prostate area).
Measured: Up to 5 years
5-year Overall Survival (OS)
Percentage of patients that remained alive 5 years after start of study treatment. Deaths were from any cause.
Measured: At 5 years
Quality of Life (QoL) - FACT-G - Prior to Therapy
The Functional Assessment of Cancer Therapy- General (FACT-G) is a self-administered 27-item questionnaire designed to measure four domains of HRQOL in cancer patients. It is comprised of physical (PWB), social (SWB), emotional (EWB), and functional (FWB) well-being subscales: (PWB; 7-items, score range 0-28), (SWB; 7-items, score range 0-28), (EWB; 6-items, score range 0-24), (FWB; 7-items, score range 0-28). The FACT-G generates an overall score of 0-108). All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much) and asks information regarding the patients last 7 days.
Measured: Prior to start of therapy
Quality of Life (QoL) - FACT-G - At 24 Months
The Functional Assessment of Cancer Therapy- General (FACT-G) is a self-administered 27-item questionnaire designed to measure four domains of HRQOL in cancer patients. It is comprised of physical (PWB), social (SWB), emotional (EWB), and functional (FWB) well-being subscales: (PWB; 7-items, score range 0-28), (SWB; 7-items, score range 0-28), (EWB; 6-items, score range 0-24), (FWB; 7-items, score range 0-28). The FACT-G generates an overall score of 0-108). All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much) and asks information regarding the patients last 7 days.
Measured: At 24 months (post-start of therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study start7 Oct 2010
- Primary completion8 Jul 2022
- Study completion8 Jul 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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adam Olson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adam Olson, University of Pittsburgh
- Investigators
- Adam Olson, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977860
- Sponsor's protocol ID
- HCC 09-031
- Status last verified
- Apr 2024
- First submitted
- 15 Sep 2009
- Last updated
- 2 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation Of Hypofractionated Stereotactic Body Radiotherapy For Low And Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT00977860
- Acronym / sponsor ID
- HCC 09-031
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Stereotactic, Radiosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Adam OlsonUniversity, hospital or other
- Study start
- 7 Oct 2010 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 16 Sep 2009 (estimated)
- Results
- Posted 2 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher gastrointestinal and genitourinary toxicity observed during a 24 month follow up and to estimate the rate of biochemical Disease-Free Survival, Phoenix and American Society for Therapeutic Radiology and Oncology definitions, at 2 years following hypofractionated stereotactic body radiation therapy for low and intermediate risk prostate cancer.
Detailed description
Radiosurgery should be ideal for treating prostate cancer because:
- targeting accuracy for static targets is excellent, with an error of about 1mm,
- it can adjust for intra-fractional organ motion, reducing the volume of the target PTV and therefore the dose to surrounding organs,
- by using over one-hundred non-conplanar beams, the dose gradient between the prostate and surrounding tissues may be superior to that achieved with conventional linear accelerators,
- the radiobiology of prostate cancer may favor large dose per fractions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT | Other | Radiation: Stereotactic Body Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically proven prostate adenocarcinoma
- Gleason score 2-7
- Biopsy within one year of date of registration
- Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)
- T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI)
Key exclusion criteria (6 listed)
- Prior prostatectomy or cryotherapy of the prostate
- Prior radiotherapy to the prostate or lower pelvis
- Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
- Chemotherapy for a malignancy in the last 5 years.
- History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.
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 TherapyAlso: CyberKnife, Trilogy, True Beam, Radiosurgery36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period | Radiation | SBRT |
Primary outcome
Rate of Acute Grade 3 or Higher GI and GU Toxicities
Time frame: Up to 90 days
Number of patients experiencing acute grade 3 or higher GI and GU toxicities. Acute toxicities are those occurring within 90 days of start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0.
Rate of Late Grade 3 or Higher GI and GU Toxicities
Time frame: After 90 days post-treatment, up to 5 years per patient
Number of patients experiencing late grade 3 or higher GI and GU toxicities. Late toxicities are those occurring after 90 days post start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0.
Biochemical Disease-Free Survival Rate (bDFS)
Time frame: Up to 5 years
Biochemical Disease-Free Survival (bDFS) as defined by Phoenix and ASTRO. Biochemical progression-free survival events were defined as PSA of ≥ 0.4 ng/mL following postoperative radiotherapy, PSA > 2.0 ng/mL at any time, clinical progression, initiation of non-protocol hormone therapy, and death from any cause.
5 secondary outcomes
Rate of Local Failure
Time frame: Up to 5 years
Rate of Distant Failure
Time frame: Up to 5 years
5-year Overall Survival (OS)
Time frame: At 5 years
Quality of Life (QoL) - FACT-G - Prior to Therapy
Time frame: Prior to start of therapy
Quality of Life (QoL) - FACT-G - At 24 Months
Time frame: At 24 months (post-start of therapy)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- 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.
Adam Olson, MD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation Therapy in people with Prostate Cancer, run by Adam Olson at 1 site 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?
The sponsor lists 16 inclusion and 6 exclusion criteria. 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 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2024). 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?
Rate of Acute Grade 3 or Higher GI and GU Toxicities (time frame: Up to 90 days). 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 2 May 2024; AzTrials last refreshed its copy on 29 Oct 2026.