Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate

Prostate Cancer Clinical Trial

Official title:

Phase II Study of Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate for Treatment of Localized, Non-Metastatic, High Risk Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01508390
• Other study ID #: H-29665
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2011
• Est. completion date: December 2027

Study information

• Verified date: July 2023
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, participants will have standard Androgen Deprivation Therapy and undergo standard external beam radiation therapy to the prostate and at-risk lymph nodes by Intensity Modulated Radiation Therapy. The subsequent *boost* radiation therapy to the prostate alone will be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation Therapy. This study will also see how CyberKnife affects the quality of the participant's life.

Description:

In this study, participants will have standard androgen deprivation therapy and undergo standard radiation therapy to the prostate and at-risk lymph nodes by intensity-modulated radiation therapy (IMRT). The subsequent *boost* radiation therapy to the prostate alone will be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation Therapy. This study will also see how CyberKnife affects the quality of the participant's life.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically proven adenocarcinoma of the prostate

1. Gleason score (2-10)

2. Biopsy within six months of date of registration

3. Patient age >18 years

2. Clinical stage (American Joint Committee on Cancer 7th Edition)

a. T-stage determined by physical exam (Digital Rectal Exam Required)

i. MRI findings (e.g. extracapsular extension) can be used to determine T-staging

b. N-stage determined using abdominopelvic CT scan and/or MRI

c. M-stage determined by physical exam, CT and/or MRI, and bone scan (must be M0, excepting Lymph nodes)

Please note: a SPECT bone scan including a CT of the abdomen and pelvis or an F18 Fluciclovine PET/CT fulfills protocol criteria for both the abdominopelvic CT and bone scan.

3. Patients must belong to one of the following risk groups:

• PSA > 20 and < 150 and/or

• Gleason 8-10 and/or

• > clinical T3a and/or

• Clinical N1

OR

• PSA 10 - 20 AND

• Gleason 7 AND

• Clinical T2b - T2c

4. Patient is receiving, or planning to receive standard androgen deprivation therapy and initial IMRT to the prostate and positive or at-risk lymph nodes.

5. Prostate volume greater than 20 cc and less than 100 cc

6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1

7. Patient has agreed to complete questionnaires

8. Signed IRB approved informed consent

9. Patient eligible to have an MRI

10. Must be able to tolerate the confinement of an MRI procedure

Exclusion Criteria:

1. No prior prostate surgery (including TURP) or prostate cancer treatment with the exception of androgen deprivation therapy

2. No prior radiotherapy to the pelvis

3. No implanted hardware (including metal) or other material that would prohibit appropriate treatment planning or treatment delivery

4. No metastatic disease, with the exception of lymph node positive disease

5. No chemotherapy for a malignancy in the last 5 years.

6. No history of an invasive malignancy (other than basal or squamous skin cancers) in the last 5 years.

7. No heart pacemaker, No metallic foreign body (metal sliver) in the eye, No aneurysm clip in the brain

8. No history of a pelvic or horseshoe kidney

9. No diagnosis of inflammatory bowel disease

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• CyberKnife Boost
21 Gy in 7 Gy per day, 3 fractions, Every other day

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Document rate of biochemical Disease-Free Survival (bDFS)	To document the rate of biochemical Disease-Free Survival (bDFS), American Society for Radiation Oncology definitions	5 years
Secondary	Rate of local failure	Rate of local failure	5 years
Secondary	Rate of distant failure	Rate of distant failure	5 years
Secondary	disease-free survival	disease-free survival	5 years
Secondary	Rate of disease-specific survival	Rate of disease-specific survival	5 years
Secondary	Rate of overall survival	Rate of overall survival	5 years
Secondary	Estimate the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity	rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity following combination androgen deprivation therapy, External Beam Radiation Therapy and CyberKnife radiosurgery as a boost	5 years