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.
Title
- Brief Title: Phase II Trial of SBRT + or - IMRT in Treatment of Patients With Clinically Confined Prostate Adenocarcinoma
- Official Title: A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) With or Without Intensity Modulated Radiation Therapy (IMRT) in the Treatment of Patients With Clinically Confined Prostate Adenocarcinoma
Clinical Trial IDs
- ORG STUDY ID:
21C-2006-01
- NCT ID:
NCT02339948
Conditions
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
SBRT only | Active Comparator | Patients assigned to this arm receive 8.0 Gy per fraction for 5 fractions for a total of 40 Gy | |
IMRT plus SBRT Boost | Active Comparator | Patients assigned to this arm receive 1.8 Gy per fraction for 25 fractions over 5 weeks for a total of 45.0 Gy followed by an SBRT boost of 5.5 Gy per fraction for 4 fractions after IMRT for a total of 22.0 Gy | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | Accepts Healthy Volunteers |
Primary Outcome Measures
Measure: | 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 |
Time Frame: | 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. |
Safety Issue: | |
Description: | 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. |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | GenesisCare USA |
Trial Keywords
Last Updated
January 13, 2020