Clinical trial NCT02339948: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Adenocarcinoma
Keywords: Locally confined
Lead sponsor: GenesisCare USA
Sponsor class: OTHER
First posted: 2015-01-16
Enrollment: 279
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
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
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: 21st Century Oncology
state: Florida
city: Plantation
country: United States
facility: 21st Century Oncology
state: Florida
city: Farmington Hills
country: United States
facility: 21st Century Oncology
state: Michigan
city: Myrtle Beach
country: United States
facility: Century Oncology
state: South Carolina
Study officials:
affiliation: GenesisCare USA
name: Constantine Mantz, MD
role: PRINCIPAL_INVESTIGATOR
References: