Clinical trial No longer in our active list Phase 2 Interventional Ages 18 and up Men only

Comparing two radiation therapies for localized prostate cancer

Official title: A Pilot Study Comparing High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy in Localized Prostate Cancer

Run by Rutgers, The State University of New Jersey · NCT04253483 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study is testing whether high-dose rate brachytherapy or stereotactic ablative radiotherapy works better for men with localized prostate cancer and how these treatments affect their quality of life.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment10 (estimated)
SponsorRutgers, The State University of New Jersey
Academic / other
Drugs / interventionschemotherapy, radiation
Locations3 sites (Livingston, New Jersey and 2 other locations)
Trial IDNCT04253483 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include men with histologically confirmed localized prostate cancer who are classified as low-risk or intermediate-risk according to specific clinical criteria.

Probably not a fit

Patients with advanced prostate cancer or those not meeting the eligibility criteria will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial evaluates the effectiveness of high-dose rate brachytherapy versus stereotactic ablative radiotherapy as monotherapy for localized prostate cancer. Patients will choose between two treatment arms: one receiving high-dose rate brachytherapy, which delivers radiation directly into the prostate, and the other receiving stereotactic ablative radiotherapy, which involves multiple external beam radiation treatments. The primary goal is to assess the feasibility of these treatments and their impact on patient-reported quality of life. Participants will be followed up periodically after treatment completion.

Why it matters

Potential benefit: If successful, this study could help identify the more effective radiation therapy for improving quality of life in patients with localized prostate cancer.

How similar studies have gone: Previous studies have shown promising results with both brachytherapy and stereotactic ablative radiotherapy, indicating potential for success in this comparative approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • RWJBarnabas Health - Saint Barnabas Medical Center, Livingston
    Livingston, New Jersey, United States
    Recruiting
  • Rutgers Cancer Institute of New Jersey
    New Brunswick, New Jersey, United States
    Recruiting
  • Rutgers New Jersey Medical School
    Newark, New Jersey, United States
    Recruiting

Study contacts

  • Principal investigator: Lara Hathout — Rutgers Cancer Institute of New Jersey

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.