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

NCT ID: NCT02339948

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 279 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2019-10-31

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.

Conditions

Prostate Adenocarcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SBRT only

Patients assigned to this arm receive 8.0 Gy per fraction for 5 fractions for a total of 40 Gy

Group Type: ACTIVE_COMPARATOR

SBRT

Intervention Type: RADIATION

8.0 Gy per fraction for 5 fractions for a total of 40 Gy

IMRT plus SBRT Boost

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

Group Type: ACTIVE_COMPARATOR

SBRT

Intervention Type: RADIATION

8.0 Gy per fraction for 5 fractions for a total of 40 Gy

Interventions

SBRT

8.0 Gy per fraction for 5 fractions for a total of 40 Gy

Intervention Type: RADIATION

Other Intervention Names

SBRT only

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

GenesisCare USA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Constantine Mantz, MD

Role: PRINCIPAL_INVESTIGATOR

GenesisCare USA

Locations

21st Century Oncology

Fort Myers, Florida, United States

21st Century Oncology

Plantation, Florida, United States

21st Century Oncology

Farmington Hills, Michigan, United States

Century Oncology

Myrtle Beach, South Carolina, United States

Countries

United States

Other Identifiers

21C-2006-01

Identifier Type: -

Identifier Source: org_study_id