Prostate Cancer
Conditions
Keywords
Prostate Cancer, Radiation, Radiotherapy, Intensity Modulated Radiotherapy, IMRT, Hypofractionated Intensity Modulated Radiotherapy, HIMRT
Brief summary
The goal of this clinical research study is to compare using external beam radiotherapy with intensity modulated beams for fewer days at a higher dose per day to the same type of therapy for more days at a lower dose per day in the treatment of prostate cancer. The safety of these treatments will also be studied and compared.
Detailed description
Patients in this study will be randomly picked (as in the toss of a coin) to be in one of two treatment groups. There is an equal chance of being in either group. Patients in Group 1 will be treated with intensity modulated radiotherapy (IMRT). These patients will receive 42 treatments, 5 days per week, over 8.5 weeks. This method has become the standard treatment at M.D. Anderson Cancer Center. Patients in Group 2 will also be treated with IMRT. However, these patients will only receive 30 treatments, 5 days per week, over 6 weeks. The dose per day for Group 2 patients is higher than for Group 1 and has the possibility of killing more tumor cells. Each external beam treatment requires about 10-20 minutes. However, patients can expect to spend 20 - 30 minutes on the treatment table because imaging measurements of prostate position will be done before each treatment. The total time in the radiation department each treatment day will be about an hour. After the radiotherapy is completed, patients will have a PSA blood test every 3 months for 2 years, then every 6 months for Years 3 - 5, then annually. They will be examined every 6 months during the first 2 years beginning 3 months after the completion of treatment, then annually. A needle biopsy of the prostate will be performed if these tests suggest recurrence. This is an investigational study. 225 patients will take part in this study. This study will take place at M. D. Anderson and possibly some affiliated hospitals.
Interventions
RADIATIONConventional Fractionated Intensity Modulated Radiotherapy
A total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV).
A total dose of 72 Gy will be delivered in 30 fractions to the PTV.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
1. Biopsy proof of adenocarcinoma of the prostate. 2. Bone scan (If PSA \>10 ng/ml or T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation. 3. CT-scan of pelvis (If Stage T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation. 4. Suitable medical condition; Zubrod \<2. 5. Pretreatment PSA \</=20 ng/ml. If PSA \<4, must have Gleason greater than or equal to 7 and/or Stage T2b-T2c. PSA within 30 days of signing protocol consent. If neoadjuvant androgen ablation has been given, then the preandrogen ablation PSA should be used for stratification. 6. Clinical (palpable) Stage T1b - T3b disease (1992 AJCC staging system). 7. While a transrectal ultrasound will be obtained before treatment, the staging will not be based on these findings. If palpable T3 disease is present, then must have Gleason score \<8 and pretreatment PSA less than or equal to 10 ng/ml 8. Gleason score \<10. 9. If Gleason score 8 or 9, then must have stage T1/T2 disease and pretreatment PSA less than or equal to 10 ng/ml. 10. The patient must be able to understand the protocol and adhere to follow-up at 6-month intervals for the first 2 years and at yearly intervals thereafter. 11. Informed consent must be given. 12. Patients randomized to Arm 1 may also participate in protocol 2004-0428.
Exclusion criteria
1. Prior pelvic radiotherapy. 2. Greater than 4 months of prior hormone ablation therapy. 3. Prior or planned radical prostate surgery. 4. Clinical, radiographic or pathologic evidence of nodal or distant metastatic disease. 5. Concurrent, active malignancy, other than nonmetastatic skin cancer or early stage -chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for greater than or equal to 5 yr then the patient is eligible. 6. Zubrod status greater than or equal to 2. 7. Pretreatment PSA \>20 ng/ml. 8. Gleason score of 10. 9. Palpable stage T3c (seminal vesicle involvement) or T4 disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conventional Radiotherapy (CIMRT) Versus Hypofractionated Radiotherapy (HIMRT) | 8.5 years | To determine the progression of the number of participants who failed treatment after receiving (CIMRT) versus (HIMRT). PSA measured on (CIMRT) and (HIMRT) for each participant on both arms. Failure was defined as Prostate-specific antigen (PSA) failure using the Phoenix definition of nadir plus 2 ng/ml, or initiation of salvage therapy. |
Countries
United States
Participant flow
Recruitment details
Patients referred for radiotherapy with histologically proven adenocarcinoma of the prostate with clinical stage T1b-T3b disease and without clinical radiographic evidence of metastasis from 2001-2010.
Pre-assignment details
225 patient enrolled on the trial, 222 patients met criteria and participated to be randomized on trial. 203 patients were deemed evaluable.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: (CIMRT) Conventional Radiotherapy Patients' radiotherapy plan includes 75.6 Gy in 1.8-Gy fractions delivered over 8.4 weeks | 111 |
| Arm 2: (HIMRT) Hypofractionated Radiotherapy Patients' radiotherapy plan includes 72 Gy in 2.4 Gy fractions delivered over 6 weeks | 111 |
| Total | 222 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Ineligible after SIM | 0 | 2 |
| Overall Study | Proceed with other treatment | 3 | 3 |
| Overall Study | Withdrawal by Subject | 6 | 3 |
Baseline characteristics
| Characteristic | Arm 1: (CIMRT) Conventional Radiotherapy | Arm 2: (HIMRT) Hypofractionated Radiotherapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 62 Participants | 73 Participants | 135 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 38 Participants | 87 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 7 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 100 Participants | 104 Participants | 204 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 5 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 13 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 85 Participants | 93 Participants | 178 Participants |
| Region of Enrollment United States | 111 participants | 111 participants | 222 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 111 Participants | 111 Participants | 222 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 101 | 1 / 102 |
| other Total, other adverse events | 56 / 101 | 79 / 102 |
| serious Total, serious adverse events | 0 / 101 | 0 / 102 |
Outcome results
Primary
Conventional Radiotherapy (CIMRT) Versus Hypofractionated Radiotherapy (HIMRT)
To determine the progression of the number of participants who failed treatment after receiving (CIMRT) versus (HIMRT). PSA measured on (CIMRT) and (HIMRT) for each participant on both arms. Failure was defined as Prostate-specific antigen (PSA) failure using the Phoenix definition of nadir plus 2 ng/ml, or initiation of salvage therapy.
Time frame: 8.5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: (CIMRT) Conventional Radiotherapy | Conventional Radiotherapy (CIMRT) Versus Hypofractionated Radiotherapy (HIMRT) | 21 Participants |
| Arm 2: (HIMRT) Hypofractionated Radiotherapy | Conventional Radiotherapy (CIMRT) Versus Hypofractionated Radiotherapy (HIMRT) | 10 Participants |