Hypofractionated Stereotactic Body Radiation Therapy (SBRT)

NCT01288534 | Completed Phase 2 Results DMC

• 2 other identifiers: 2010.064HUM00041474
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of using radiation therapy with 5 fractions of radiation to treat prostate cancer with guidance of radiation using the Calypso 4D Treatment System (Calypso).A number of recent studies have used 5 radiation fraction to treat prostate cancer over 2-3 weeks as compared to the typical treatment which would involve 40-42 smaller radiation fractions over 8-9 weeks. This type of radiation using a smaller number of treatments has been called hypofractionated radiation therapy. The Calypso is a new technique which uses beacons implanted into the prostate which using radio signals are able to localize and track the position of the prostate continuously during radiation therapy. The Calypso system has been approved by the United States Food and Drug Administration (FDA) for guidance of radiation therapy during the treatment of prostate cancer and is being utilized all across the United States. However, it has not been tested for hypofractionated radiation therapy.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With a Minimally Detected Decline (MDD) in Quality of Life (QOL)

  To evaluate the safety of the proposed hyperfractionation regimen of 5 fractions of radiation to treat prostate cancer with guidance of radiation using the Calypso 4D Treatment System (Calypso, and to compare it to that expected from conventional treatment, which would involve 40-42 smaller radiation fractions over 8-9 weeks. Percentage of patients with a MDD in Quality of Life (QOL) surveys for urinary incontinence (UI), urinary obstructive (UO), bowel (BS), and sexual (SS) domains were reviewed at 6 months and 24 months.

  24 months

Secondary Outcomes (4)

• Percentage of Patients With a PSA Nadir of <3.35 ng/ml at 12 Months

  1 Year

• Relation Between Dose Distribution and Toxicities.

  5 years

• Relation Between Reconstructed Delivered Dose Distributions.

  5 years

• Frequency of Required Interventions.

  5 years

Study Arms (1)

Radiation Treatment

EXPERIMENTAL

Radiation: Radiation Therapy

Interventions

Radiation Therapy RADIATION

Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.

Radiation Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days of enrollment
• Signed informed consent
• Gleason score ≤ 7
• If Gleason 7 (3+4=7 or 4+3=7) then \<50% of biopsy cores must be positive for any pathologic grade of prostate cancer
• If Gleason score \<7 then there is no limit on the percentage of biopsy cores involved by prostate cancer
• PSA (within 90 days prior to enrollment)
• ≤ 15 ng/ml prior to start of therapy if Gleason ≤ 6 and
• ≤ 10 ng/ml prior to start of therapy if Gleason 7
• No plan to use hormone therapy prior to evidence of biochemical failure(ie: No neoadjuvant or adjuvant ADT)
• Tumor stage: T1a, T1b, T1c, T2a, T2b
• ECOG Performance Status 0-1

You may not qualify if:

• A history of other malignancy diagnosed within the previous 60 months except for non-melanoma skin cancer.
• Any patients who have received other investigational therapy within the last 60 days
• Individuals that have previously been implanted with permanent Beacon transponders
• Patients that have any prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip)
• Patients with implanted pacemaker or defibrillators
• Patients who are felt to have body habitus not conducive to tracking with Calypso beacons
• Positive lymph nodes or metastatic disease from prostate cancer
• Tumor stage: T2c, T3, or T4
• Previous pelvic radiation therapy
• Previous surgery or chemotherapy for prostate cancer
• Previous transuretheral resection of the prostate (TURP) or cryotherapy to the prostate
• Prior hormone therapy or plans for concurrent or post treatment adjuvant hormonal therapy or chemotherapy
• Hormone therapy to include LHRH agonist or oral anti-androgen
• Finasteride and Dutasteride use not excluded
• Concomitant antineoplastic therapy (including surgery, cryotherapy, conventionally fractionated radiation therapy, and chemotherapy) while on this protocol

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Fox Chase Cancer Center: collaborator
• Cedars-Sinai Medical Center: collaborator
• Washington University School of Medicine: collaborator

Study Sites (2)

The Radiological Associates of Sacremento

Sacramento, California, 95815, United States

Location

University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dr. Daniel Spratt, M.D.
• Organization: University of Michigan Comprehensive Cancer Center

sprattda@med.umich.edu

734-936-9630

Study Officials

• Daniel Spratt, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: February 2, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: October 24, 2017
• Results First Posted: June 9, 2016

Record last verified: 2017-09

Locations

US (2)