A Phase II Randomized Pilot Study Comparing High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy in Localized Prostate Cancer.
AIM 1: To assess differences in HRQoL in the acute and long-term setting using the Expanded Prostate Index Composite (EPIC)-26 short form. Patient-reported HRQoL scores in the bowel, sexual and urinary domains will be evaluated at baseline, 1,3,6,9,12,18,24 and 36 months. A 10-point difference between the two treatment modalities will be considered significant.
AIM 2: To assess tumor control and determine if the 36-month repeat prostate biopsy is a predictor of biochemical failure. A repeat prostate biopsy at 36 months and serial Prostate-Specific Antigen (PSA) measurements will be performed to assess local tumor control and biochemical failure, respectively. We will evaluate the predictive value of posttreatment prostate biopsy at 36 months with respect to biochemical failure.
- Rutgers Cancer Institute of New Jersey
- RWJBarnabas Health
- Cooperman Barnabas, Livingston
- Rutgers Cancer Institute of New Jersey-University Hospital
Inclusion Criteria
- Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9
months. Patients on active surveillance with evidence of disease progression are
eligible to the protocol as long as they meet the eligibility criteria and have a
recent prostate biopsy (within 9 months)
- Low-risk and intermediate-risk patients are eligible according to the following
guidelines:
- Low and intermediate-risk disease defined as:
- Clinical stage T1-T2 and Gleason =< 7 and prostate specific antigen (PSA) <
15 ng/ml
- Lymph node evaluation by either computed tomography (CT) or magnetic resonance imaging
(MRI) and bone scan are optional and are left at the discretion of the treating
physician
- Prostate MRI is recommended by not mandatory
- No alpha reductase inhibitors use within 2 weeks of randomization. A washout period of
2 weeks is required prior to randomization
- Eastern Cooperative Oncology Group status 0-1
- Judged to be medically fit for brachytherapy by a radiation oncologist
- Concurrent, neoadjuvant and/or adjuvant androgen deprivation therapy (ADT) is not
permitted
- Prostate volume by trans-rectal ultrasound (TRUS) =< 60 cc
- International Prognostic Scoring System (IPSS) =< 20 (alpha blockers allowed)
- Patients must sign a study specific informed consent form prior to study entry
- Patients must by accessible for treatment and follow-up. Patients registered on this
trial must be treated and followed at the participating center. Investigators must
assure themselves that patients enrolled in this trial will be available for complete
documentation of the treatment, adverse events, and follow up
- Protocol treatment is to begin within 4 weeks of patient randomization
Exclusion Criteria
- Patients with a history of other malignancies, except: adequately treated non-melanoma
skin cancer, or other solid tumors curatively treated with no evidence of disease for
>= 5 years
- Prior or current bleeding diathesis
- Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior
chemotherapy for prostate cancer, prior transurethral resection of the prostate
(TURP), prior cryosurgery of the prostate
- Stage T3b and evidence of nodal or distant metastatic disease on diagnostic CT, MRI or
bone scan
- Subjects who have plans to receive other concomitant or post treatment adjuvant
antineoplastic therapy while on this protocol including surgery, cryotherapy,
conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy given as
part of the treatment of prostate cancer
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within
the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial for fungal infection requiring intravenous antibiotics at the
time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy within 30 days before
registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulations defects;
note, however, that laboratory tests for liver function and coagulation
parameters are not required for entry into this protocol
- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease
Control and Prevention (CDC) definition; note, however, that human
immunodeficiency virus (HIV) testing is not required for entry into this
protocol. The need to exclude patients with AIDS from this protocol is necessary
because the treatments involved in this protocol may be significantly
immunosuppressive. Protocol-specific requirements may also exclude
immumo-compromised patients
- Patients with history of inflammatory colitis (including Crohn's disease and
ulcerative colitis) or collagen vascular diseases including rheumatoid arthritis
and lupus are not eligible
- Subjects who have a history of significant psychiatric illness
- Men of reproductive potential who do not agree that they or their partner will use an
effective contraceptive method such as condom/diaphragm and spermicidal foam,
intrauterine device (IUD), or prescription birth control pills
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.