Phase II Trial of SBRT + or - IMRT in Treatment of Patients With Clinically Confined Prostate Adenocarcinoma



Status:Recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/11/2019
Start Date:June 2006
End Date:December 2020
Contact:Rudi Ross, BS, CCRC
Email:rudi.ross@21co.com
Phone:239-938-9366

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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

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.

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.

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
We found this trial at
4
sites
Myrtle Beach, South Carolina 29577
Principal Investigator: Patrick Francke, MD
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Myrtle Beach, SC
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Farmington Hills, Michigan 48334
Principal Investigator: Jeffrey Forman, MD
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Farmington Hills, MI
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Fort Myers, Florida 33907
Principal Investigator: Constantine Mantz, MD
Phone: 239-344-2232
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Fort Myers, FL
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Plantation, Florida 33324
Principal Investigator: Eduardo Fernandez, MD
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from
Plantation, FL
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