Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: CyberKnife Boost

• Registration Number: NCT01508390
• Lead Sponsor: Boston Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-12-09
• Study First Submitted QC: 2012-01-11
• Study First Posted: 2012-01-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Boost	CyberKnife Boost	CyberKnife Boost 21 Gy in 7 Gy per day, 3 fractions, Every other day

Primary Outcome Measures

Name	Time	Method
Document rate of biochemical Disease-Free Survival (bDFS)	5 years	To document the rate of biochemical Disease-Free Survival (bDFS), American Society for Radiation Oncology definitions

Secondary Outcome Measures

Name	Time	Method
Rate of local failure	5 years	Rate of local failure
Rate of distant failure	5 years	Rate of distant failure
disease-free survival	5 years	disease-free survival
Rate of disease-specific survival	5 years	Rate of disease-specific survival
Rate of overall survival	5 years	Rate of overall survival
Estimate the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity	5 years	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

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States