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

Prostate Adenocarcinoma Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT02339948
• Other study ID #: 21C-2006-01
• Status: Completed
• Phase: N/A
• Start date: June 2006
• Est. completion date: October 2019

Study information

• Verified date: January 2020
• Source: 21st Century Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostatic Neoplasms

Intervention

Radiation:
• SBRT
8.0 Gy per fraction for 5 fractions for a total of 40 Gy

Locations

Country	Name	City	State
United States	21st Century Oncology	Farmington Hills	Michigan
United States	21st Century Oncology	Fort Myers	Florida
United States	Century Oncology	Myrtle Beach	South Carolina
United States	21st Century Oncology	Plantation	Florida

Sponsors (1)

Lead Sponsor	Collaborator
21st Century Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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.