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Which radiation is easier on prostate cancer patients? small trial aims to find out
NCT ID NCT04253483
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase II trial compares two types of radiation therapy for men with early-stage prostate cancer that hasn't spread. One method places a radioactive seed directly into the prostate for a few minutes, while the other delivers radiation from outside the body in five sessions. The study tracks how each treatment affects patients' quality of life over three years. Only 14 men are enrolled, so this is a small pilot study to see if a larger comparison is feasible.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy (high-dose rate brachytherapy and stereotactic ablative radiotherapy)
- What this could lead to
- If successful, this trial could help doctors choose which radiation method causes fewer side effects and better maintains quality of life for men with localized prostate cancer.
- What could go wrong
- This is a very small pilot study with only 14 participants, so results may not apply to all patients. It compares two existing treatments, so no new cure is being tested.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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14 people
The number who actually took part.
- Started
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Jul 2019
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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RWJBarnabas Health - Saint Barnabas Medical Center, Livingston
Livingston, New Jersey, 07039, United States
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Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
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Rutgers New Jersey Medical School
Newark, New Jersey, 07101, United States
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Other studies related to the condition(s) this trial covers.
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