A Study of Experimental Stereotactic Body Radiation Therapy (radiation treatment in a shorter amount of time) For Prostate Cancer

Enter your info and the study team will contact you soon!
Your data is securely stored and only shared with the research team
Logo Image
"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Male
Healthy Volunteers: No
Keywords: prostate cancer, cancer, radiation
Type: Radiation study, Phase 3
Target:
15 Participants
Investigator:
Description
This study will compare any good and bad effects of using stereotactic body radiation therapy (SBRT). SBRT gives treatment in a shorter amount of time compared to the usual radiation therapy.

SBRT is experimental for treating this type of cancer. SBRT uses special equipment to precisely deliver radiation to tumors in the body. Both the study and the usual radiation treatments use daily images to guide the radiation treatment to protect normal tissue. The study treatment may prevent the tumor from returning but it could also cause side effects.

This study will test whether using SBRT is better, the same, or worse than the usual approach.
This study requires

Most of the exams, tests, and procedures you will have are part of the usual approach for your cancer. However, there are some extra assessments that you will need to have if you take part in this study.

Quality of Life Study

If you speak and understand English, French, or Spanish, you will be required to fill out 2 forms, one about general health and the other about your urinary and bowel symptoms, as well as sexual and hormonal symptoms. Researchers will use this information to learn more about how cancer and cancer treatment affect people.

You will be asked to fill out these forms at 4 times:

  • Before you begin study treatment,

  • When you are finished radiation,

  • At 12 and 24 months after you finish radiation

Who can participate

Inclusion criteria:

  • Previously untreated localized adenocarcinoma of the prostate with the following clinical findings:
  • Clinical stage by digital rectal exam of either T1c or T2a/b (limited to one side of the gland); (American Joint Committee on Cancer [AJCC], version 7) or cT1a-c or 2a or 2b, stage group IIA or IIB (AJCC, version 8); both versions 7 and 8 staging should be recorded
  • Patients in active surveillance who elect to be treated are eligible if they meet protocol requirements
  • Stages T1a-T1b are eligible if patient underwent transurethral prostatic resection (TURP) previously Gleason score must be Gleason 7(3+4) with a PSA < 20 ng/mL, or Gleason 6(3+3) with a PSA > 10 ng/mL and < 20 ng/mL; (AJCC, version 7) or group grade 1 or 2, stage Group IIA or IIB (AJCC version 8)
  • If patient is receiving a 5-alpha reductase inhibitor at the time of enrollment the baseline PSA value will be assumed to be double the initial value and the medication should be discontinued but does not need to have a washout period to participate, to remain eligible a PSA drawn while still on the medicine must be:
  • < 10 ng/mL to remain eligible if Gleason 7(3+4)
  • Stratification level 1 if PSA < 5 ng/mL and level 2 if less than 10 ng/mL
  • 5 ng/mL and less than 10 ng/mL for Gleason 6(3+3)

  • Stratification level 3
  • Percent of submitted positive core biopsies must be < 50% of all sextants
  • NOTE: all cores from a targeted lesion will be counted as an N of 1 core for calculating percent positive cores in total
  • The prostate volume must be < 60 cc as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including magnetic resonance imaging (MRI) or computed tomography (CT) scan
  • History and physical including a digital rectal exam 60 days prior to registration
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1 60 days prior to registration
  • MRI of pelvis within 90 days prior to registration
  • Bone scan or sodium fluoride positron emission tomography (PET) scan within 90 days prior to registration
  • Charlson modified co-morbidity score =< 3 for patients under 60 and =< 4 for patients 60 and over 21 days prior to registration
  • International prostate symptom score (IPSS) of < 15 21 days prior to registration
  • The patient must provide study-specific informed consent prior to study entry
  • Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire
  • Completion of all items of the EPIC-26 which will be data entered at registration 60 days prior to registration
  • Only English, Spanish, and French-speaking patients are eligible to participate

Exclusion criteria:

  • Definitive clinical or radiologic evidence of metastatic disease; no nodal involvement or evidence of metastatic disease allowed as defined by screening of the pelvis and a bone scan or sodium fluoride PET scan
  • Definitive T3 disease on MRI
  • Prior or current invasive malignancy with current evidence of active disease within the past 3 years
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; must be off treatment for at least 3 years; [applicable only to studies that incorporate systemic therapy]
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • The use of hormonal therapy is not allowed; if the patient in on a 5-alpha reductase inhibitor, then they should be stopped prior to treatment once enrolled onto the study; no washout period is required for this study to participate
  • Severe, active co-morbidity defined as follows:
  • Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter; Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; Note also that HIV testing is not required for eligibility for this protocol
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol; (patients on Coumadin or other blood thinning agents are eligible for this study)
  • Contraindication to MRI
  • Cardiac pacemaker or defibrillator
  • Surgically implanted electrical devices such as spinal stimulation devices or intracranial stimulation devices, cochlear implants, the presence of metallic foreign bodies in the orbits, and incompatible old mechanical heart valves and aneurysm clips
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
If you are in group 1, you will receive 28 radiation treatments over approximately 6 weeks. If you are in group 2, you will receive 5 radiation treatments over approximately 2 weeks. After both groups finish radiation, the study team will follow your condition every 3 months for 2 years, then every 6 months for the next 3 years, and then yearly.
Recruitment period
From Feb. 7, 2018
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • Stage II Prostate Adenocarcinoma

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


Sending

Send SMS with Study Info:

SMS Sent!

Share Study Info via Email:


E-mail Preview