Prostate Cancer
Conditions
Keywords
Prostate Cancer, Proton Radiation
Brief summary
The purpose of this study is to see what effects, good and/or bad, proton based radiation combined with low dose chemotherapy and hormonal therapy, has on patients and their cancer.
Interventions
RADIATION< 15% risk of + LN
Total of 54 Cobalt gray equivalent (CGE) over 30 treatments to prostate + seminal vesicles (SV), then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during radiation therapy (RT) followed by androgen deprivation therapy for 6 months.
RADIATION> 15% risk of + LN
Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.
Sponsors
University of Florida
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
\* Adenocarcinoma of the prostate.
Exclusion criteria
* Previous prostate cancer treatment such as chemotherapy and/or pelvic radiation. * Active inflammatory bowel disease (diverticulitis, Crohn's disease or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed.) * History of hip replacement. * Prior intrapelvic surgery. This includes the following: * Transrectal or rectal surgery other than polypectomy or hemorrhoid removal or banding * Transabdominal pelvic surgery * Bladder surgery * Prior myocardial infarction (MI) or congestive heart failure (CHF). * Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Grade 3 or Higher Treatment-related Toxicity Rate. | 6 months after the completion of radiation therapy | Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria. |
Secondary
| Measure | Time frame |
|---|---|
| Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters. | After radiation: every 6 months for 3 years, then annually for 20 years |
| Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes. | After radiation: every 6 months for 3 years, then annually for 20 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HR-A \< 15% risk of + LN
\< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months. | 58 |
| HR-B \> 15% risk of + LN
\> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months. | 19 |
| Total | 77 |
Baseline characteristics
| Characteristic | HR-B | HR-A | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 42 Participants | 57 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 16 Participants | 20 Participants |
| Age, Continuous | 69 years | 68 years | 68 years |
| Region of Enrollment United States | 19 participants | 58 participants | 77 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 19 Participants | 58 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 58 | 11 / 19 |
| serious Total, serious adverse events | 1 / 58 | 3 / 19 |
Outcome results
Primary
Acute Grade 3 or Higher Treatment-related Toxicity Rate.
Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria.
Time frame: 6 months after the completion of radiation therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HR-A | Acute Grade 3 or Higher Treatment-related Toxicity Rate. | 1 participants |
| HR-B | Acute Grade 3 or Higher Treatment-related Toxicity Rate. | 3 participants |
p-value: <0.0001Chi-squared
Secondary
Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters.
Time frame: After radiation: every 6 months for 3 years, then annually for 20 years
Secondary
Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes.
Time frame: After radiation: every 6 months for 3 years, then annually for 20 years