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

Not Applicable

Completed

• Conditions: Prostate Adenocarcinoma
• Interventions: Radiation: SBRT

• Registration Number: NCT02339948
• Lead Sponsor: GenesisCare USA

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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-15
• Study First Posted: 2015-01-16
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 279

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SBRT only	SBRT	Patients assigned to this arm receive 8.0 Gy per fraction for 5 fractions for a total of 40 Gy
IMRT plus SBRT Boost	SBRT	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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Century Oncology; 🇺🇸 Myrtle Beach, South Carolina, United States

21st Century Oncology; 🇺🇸 Farmington Hills, Michigan, United States