Prostate Cancer
Conditions
Keywords
Prostate, Stereotactic, Radiosurgery
Brief 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 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.
Interventions
RADIATIONStereotactic Body Radiation Therapy
36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period
Sponsors
Adam Olson
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Acute Grade 3 or Higher GI and GU Toxicities | 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 | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QoL) - FACT-G - Prior to Therapy | Prior to start of 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. |
| Rate of Local Failure | Up to 5 years | 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. |
| Quality of Life (QoL) - FACT-G - At 24 Months | At 24 months (post-start of 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. |
| Rate of Distant Failure | Up to 5 years | 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). |
| 5-year Overall Survival (OS) | At 5 years | Percentage of patients that remained alive 5 years after start of study treatment. Deaths were from any cause. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SBRT Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period | 163 |
| Total | 163 |
Baseline characteristics
| Characteristic | SBRT |
|---|---|
| Age, Continuous | 67.80 years STANDARD_DEVIATION 6.929 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 162 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 148 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 163 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 15 / 163 |
| other Total, other adverse events | 9 / 163 |
| serious Total, serious adverse events | 2 / 163 |
Outcome results
Primary
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.
Time frame: Up to 5 years
Population: All enrolled patients that received SBRT therapy with PSA assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SBRT | Biochemical Disease-Free Survival Rate (bDFS) | 7 Participants |
Primary
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.
Time frame: Up to 90 days
Population: Patients that received SBRT therapy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SBRT | Rate of Acute Grade 3 or Higher GI and GU Toxicities | 2 Participants |
Primary
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.
Time frame: After 90 days post-treatment, up to 5 years per patient
Population: All enrolled patients that received SBRT therapy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SBRT | Rate of Late Grade 3 or Higher GI and GU Toxicities | 0 Participants |
Secondary
5-year Overall Survival (OS)
Percentage of patients that remained alive 5 years after start of study treatment. Deaths were from any cause.
Time frame: At 5 years
Population: All patients that received SBRT therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SBRT | 5-year Overall Survival (OS) | 93.87 percentage of participants |
Secondary
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.
Time frame: At 24 months (post-start of therapy)
Population: Patients that received SBRT therapy, that completed quality of life assessments Prior to therapy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SBRT | Quality of Life (QoL) - FACT-G - At 24 Months | EWB | 21.25 score on a scale | Standard Deviation 3.37 |
| SBRT | Quality of Life (QoL) - FACT-G - At 24 Months | FWB | 22.85 score on a scale | Standard Deviation 5.824 |
| SBRT | Quality of Life (QoL) - FACT-G - At 24 Months | FACTG | 93.15000 score on a scale | Standard Deviation 14.605211 |
| SBRT | Quality of Life (QoL) - FACT-G - At 24 Months | PWB | 26.10 score on a scale | Standard Deviation 2.791 |
| SBRT | Quality of Life (QoL) - FACT-G - At 24 Months | SWB | 21.95238 score on a scale | Standard Deviation 6.645819 |
Secondary
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.
Time frame: Prior to start of therapy
Population: Patients that received SBRT therapy, that completed quality of life assessments Prior to therapy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SBRT | Quality of Life (QoL) - FACT-G - Prior to Therapy | SWB | 23.70186 score on a scale | Standard Deviation 3.641432 |
| SBRT | Quality of Life (QoL) - FACT-G - Prior to Therapy | EWB | 19.58 score on a scale | Standard Deviation 4.449 |
| SBRT | Quality of Life (QoL) - FACT-G - Prior to Therapy | FACTG | 92.78983 score on a scale | Standard Deviation 12.323307 |
| SBRT | Quality of Life (QoL) - FACT-G - Prior to Therapy | PWB | 26.06019 score on a scale | Standard Deviation 2.716213 |
| SBRT | Quality of Life (QoL) - FACT-G - Prior to Therapy | FWB | 23.44 score on a scale | Standard Deviation 5.417 |
Secondary
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).
Time frame: Up to 5 years
Population: Data were not collected.
Secondary
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.
Time frame: Up to 5 years
Population: Data were not collected.