Prostate Adenocarcinoma
Conditions
Keywords
Locally confined
Brief summary
Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a and PSA \<10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total of 40 Gy. Intermediate risk patients (T2b or PSA \>10 ng/ml orGleason Score 7) will receive 1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy.
Detailed description
Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a and PSA \<10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total of 40 Gy. Intermediate risk patients (T2b or PSA \>10 ng/ml orGleason Score 7) will receive 1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy. All patients will be assessed for toxicity at periodic time points following completion of treatment.
Interventions
RADIATIONSBRT
8.0 Gy per fraction for 5 fractions for a total of 40 Gy
Sponsors
GenesisCare USA
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Histologically determined adenocarcinoma is required. * All other histologies are excluded. * Tissue for diagnosis must be obtained by transrectal ultrasound biopsy. * Gleason scoring classification of the biopsy specimen is required and must be greater than or equal to 7. * 2002 AJCC clinical cancer stage as determined by either urologist or radiation oncologist must be T1c - T2b, N0, M0. * N0 stage may be assigned following either negative imaging or negative pathologic assessment. * Prostate volume as assessed by TRUS must be less than 60 cc. 3.1.5. * PSA must be less than 20 ng/ml. , * Age ≥ 18, * IPSS voiding symptoms score must be less than 18, * Study consent form must be signed by the patient.
Exclusion criteria
* Gleason score of 8 - 10, * Clinical stage T3 - T4, * Age ≤ 18, * Any evidence of nodal (N1) or distant (M1) disease, * Prostate volume as assessed by TRUS \> 60 cc, * PSA \> 20 ng/ml, * IPSS voiding symptoms score \> 18, * Prior TURP, * Prior pelvic radiotherapy or chemotherapy, * Prior prostatectomy, * Prior cancer other than basal cell or squamous cell skin carcinoma unless free of disease for \> 5 years, * Current medical or psychiatric illness that may interfere with treatment completion and followup, * Hip prosthesis, * Unable or unwilling to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To estimate the rate of chronic grade 3 - 5 genitourinary (GU) and gastrointestinal (GI) toxicity of SBRT either as a boost following conventionally fractionated IMRT or as a monoradiotherapy | Periodical (baseline, during treatment, and at 1 month, 3 months, 6 months, 9 months, and 12 months post treatment. For the second and third years after therapy completion, follow-up visits will be every 6 months. Then annually for ____ years. | At baseline, during treatment, and at 1 month, 3 months, 6 months, 9 months, and 12 months post treatment. For the second and third years after therapy completion, follow-up visits will be every 6 months. After the third year after therapy completion, follow-up visits will be annually for life, up to 10 years. |
Countries
United States
Outcome results
None listed