Erprobung einer kurzen Strahlentherapie-Anwendung im Vergleich zur konventionellen Strahlentherapie bei Prostatakrebs

Radiation: Intensity-Modulated Radiation Therapy (IMRT);Radiation: Stereotactic Body Radiation Therapy (SBRT)

Gender: Male
Maximum age: N/A
Minimum age: 18 Years

Inclusion Criteria:

- Previously untreated (no local therapy such as surgery, radiation cryotherapy, HIFU,
etc.) 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,

- Stages T1a-T1b are eligible if patient underwent transurethral prostatic
resection (TURP),

- The patient must meet one of the following 3 criteria: 1) Gleason score must be
Gleason 7(3+4) with a PSA < 20 ng/mL, or 2) Gleason 6(3+3) with a PSA > 10 ng/mL
and < 20 ng/mL which is considered intermediate risk and eligible for the study.
(AJCC, version 7) or 3) Group Grade 1 with a PSA > 10 ng/mL and < 20 ng/mL or 2
with a PSA < 20 ng/mL.

- If patient is receiving a 5-alpha reductase inhibitor at the time of
enrollment the baseline PSA value may be double the initial value and the
medication should be discontinued but a washout period is not required to
eligible, a PSA drawn while still on the medicine must be:

- < 10 ng/mL if Gleason 7(3+4) (Note: This patient would be on
stratification level 1 if PSA < 5 ng/mL and stratification level 2 if
less than 10 ng/mL).

- > 5 ng/mL and less than 10 ng/mL for Gleason 6(3+3) (Note: This
patients would be on stratification level 3).

- The prostate volume must be < 70 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

- Patients in active surveillance who elect to be treated are eligible if they meet
protocol requirements

- 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 the prostate and pelvis (per institutional SOC - should be compliant with
PIRADSv2.1 guidelines) within 1 year prior to registration

- Bone scan or sodium fluoride positron emission tomography (PET) scan within 120 days
prior to registration

- Charlson modified co-morbidity score =< 4 for patients under 60 and =< 5 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 2 years

- Exceptions: Non-melanomatous skin cancer, carcinoma in situ of the male breast,
penis, oral cavity, or stage Ta of the bladder, or stage I completely resected
melanoma.

- 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

- 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