Prostate Adenocarcinoma
Conditions
Keywords
Prostate neoplasm, Prostate Cancer
Brief summary
The primary objective of this study is to document the effectiveness of Cyberknife stereotactic body radiotherapy (SBRT) in the treatment of intermediate and high-risk localized prostate cancer defined by biochemical Disease-Free Survival (bDFS), using Phoenix and American Society of Therapeutic Radiation and Oncology (ASTRO) definitions, at 5 years. During the prostate-specific antigen era, an ever-increasing percentage of men with prostate cancer have presented with clinically localized, potentially curable disease. Although conventional treatment options are potentially curative in selected patients, these treatments also have drawbacks, including the risk of negative long-term quality of life consequences and serious complications. The CyberKnife® system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. Intermediate risk patients will be treated with either CyberKnife® Stereotactic Body Radiation Therapy (SBRT) monotherapy or CyberKnife® SBRT boost followed by Intensity Modulated Radiation Therapy (IMRT). High risk patients will be treated with CyberKnife® SBRT boost followed by IMRT. Treatment will last 4-7 days. Patients will complete the QOL questionnaires before treatment. Questionnaires will also be completed during follow-up visits at 1, 3 , 6, 12, 18, 24, 30 and 36 months then every 12 months until year 5.
Detailed description
The purpose of this project is to evaluate the efficacy and Health-Related Quality of Life (HRQOL) in intermediate and high-risk prostate cancer patients treated with SBRT as monotherapy or as a boost in combination with IMRT.
Interventions
RADIATIONCyberKnife
OTHERAndrogen Deprivation Therapy (ADT)
RADIATIONIntensity Modulated radiation therapy (IMRT)
Per current standard of care
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be ≥ 18 years of age. * Histologically proven prostate adenocarcinoma * Gleason score 2-10 (reviewed by reference lab) * Biopsy within one year of date of registration * Clinical stage T1b-T4, N0-Nx, M0-Mx (AJCC 7th Edition) * T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI; see section 4.5) * M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases. * PSA ≤ 50 ng/ml, CBC, platelets, BUN, creatinine prior to treatment * Patients belonging in one of the following risk groups: * Intermediate: CS T2b-c and Gleason \<6 and PSA ≤ 10, or CS T1b-T2b, and Gleason 7 and PSA ≤ 10 ng/ml, or Gleason \<6 and PSA 11-20 ng/ml * High: CS T3-4, Gleason score \>7and PSA\<50 * Prostate volume: ≤ 100 cc * Determined using: volume = π/6 x length x height x width * Measurement from MRI, CT or ultrasound prior to registration. * ECOG performance status 0-1 * No prior prostatectomy or cryotherapy of the prostate * No prior radiotherapy to the prostate or lower pelvis * No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion. * No chemotherapy for a malignancy in the last 5 years. * No history of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical Disease-Free Survival (bDFS), Using Phoenix and ASTRO Definitions | 3 years | Phoenix definition: Biochemical recurrence of prostate cancer (PCa) after curative radiotherapy defined as a prostate-specific antigen (PSA) rise of ≥2 ng/ml above the nadir. Astro definition: Biochemical failure in prostate cancer defined as three consecutive rises in prostate-specific antigen (PSA) after a nadir. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure the Rates of Acute and Late Grade 3-5 Gastrointestinal and Genitourinary Toxicity | 3 years | Acute toxicity is graded based upon Common Terminology Criteria for Adverse Events (CTCAE). The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 is a standardized system used to classify and grade the severity of adverse events (AEs) experienced by cancer patients during treatment, with a grading scale ranging from 1 (mild) to 5 (death). |
| Expanded Prostate Cancer Index Composite Epic-26 | 3 years | The 26-item version of EPIC, also known as EPIC Short Form or EPIC-26, contains five symptom domains (urinary incontinence, urinary irritative/obstructive, sexual, bowel, hormonal), scored from 0 (worst) to 100 (best). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intermediate Risk Short term (4-6 months) androgen deprivation therapy (ADT) per current standard of care + CyberKnife 21 Gy (7 Gy x 3) and Prostate/SV Intensity Modulated radiation therapy (IMRT) 45-50.4 Gy
OR
Short term (4-6 months)androgen deprivation therapy + CyberKnife 36.35 Gray (7.27 Gray x 5)
CyberKnife
Androgen Deprivation Therapy (ADT)
Intensity Modulated radiation therapy (IMRT): Per current standard of care | 53 |
| High Risk Short or Long term (6 months - 3 years) androgen deprivation therapy (ADT) + 45-50.4 Gy and Pelvis Intensity Modulated radiation therapy (IMRT) per current standard of care + 21 Gy (7 Gy x 3) CyberKnife boost
CyberKnife
Androgen Deprivation Therapy (ADT)
Intensity Modulated radiation therapy (IMRT): Per current standard of care | 30 |
| Total | 83 |
Baseline characteristics
| Characteristic | High Risk | Total | Intermediate Risk |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 19 Participants | 58 Participants | 39 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 25 Participants | 14 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 30 Participants | 83 Participants | 53 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 30 Participants | 83 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 30 |
| other Total, other adverse events | 0 / 53 | 0 / 30 |
| serious Total, serious adverse events | 0 / 53 | 0 / 30 |
Outcome results
Primary
Biochemical Disease-Free Survival (bDFS), Using Phoenix and ASTRO Definitions
Phoenix definition: Biochemical recurrence of prostate cancer (PCa) after curative radiotherapy defined as a prostate-specific antigen (PSA) rise of ≥2 ng/ml above the nadir. Astro definition: Biochemical failure in prostate cancer defined as three consecutive rises in prostate-specific antigen (PSA) after a nadir.
Time frame: 3 years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intermediate Risk | Biochemical Disease-Free Survival (bDFS), Using Phoenix and ASTRO Definitions | Phoenix Definition | 46 Participants |
| Intermediate Risk | Biochemical Disease-Free Survival (bDFS), Using Phoenix and ASTRO Definitions | Astro Definition | 45 Participants |
| High Risk | Biochemical Disease-Free Survival (bDFS), Using Phoenix and ASTRO Definitions | Astro Definition | 27 Participants |
| High Risk | Biochemical Disease-Free Survival (bDFS), Using Phoenix and ASTRO Definitions | Phoenix Definition | 27 Participants |
Secondary
Expanded Prostate Cancer Index Composite Epic-26
The 26-item version of EPIC, also known as EPIC Short Form or EPIC-26, contains five symptom domains (urinary incontinence, urinary irritative/obstructive, sexual, bowel, hormonal), scored from 0 (worst) to 100 (best).
Time frame: 3 years
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Intermediate Risk | Expanded Prostate Cancer Index Composite Epic-26 | 78.73 units on a scale |
| High Risk | Expanded Prostate Cancer Index Composite Epic-26 | 78.73 units on a scale |
Secondary
Measure the Rates of Acute and Late Grade 3-5 Gastrointestinal and Genitourinary Toxicity
Acute toxicity is graded based upon Common Terminology Criteria for Adverse Events (CTCAE). The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 is a standardized system used to classify and grade the severity of adverse events (AEs) experienced by cancer patients during treatment, with a grading scale ranging from 1 (mild) to 5 (death).
Time frame: 3 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intermediate Risk | Measure the Rates of Acute and Late Grade 3-5 Gastrointestinal and Genitourinary Toxicity | 2 Participants |
| High Risk | Measure the Rates of Acute and Late Grade 3-5 Gastrointestinal and Genitourinary Toxicity | 5 Participants |