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Stage I Prostate Cancer AJCC v8Phase 2NCT04253483

Comparison of High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy for the Treatment of Localized Prostate Cancer

A Phase 2 study testing High-Dose Rate Brachytherapy, Quality-of-Life Assessment and Questionnaire Administration in people with Stage I Prostate Cancer AJCC v8 and Stage II Prostate Cancer AJCC v8, run by Rutgers, The State University of New Jersey at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase II trial compares high-dose rate brachytherapy and stereotactic ablative radiotherapy as monotherapy in treating patients with prostate cancer that has not spread to other parts of the body (localized). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
High-Dose Rate Brachytherapy, Quality-of-Life Assessment and Questionnaire Administration
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
3 sitesUnited States
Study dates
17 Jul 2019to 1 Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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:
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  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • RWJBarnabas Health - Saint Barnabas Medical Center, Livingston

    Livingston, New Jersey, 07039

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07101

Other trials in United States

About this study

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

This phase II trial compares high-dose rate brachytherapy and stereotactic ablative radiotherapy as monotherapy in treating patients with prostate cancer that has not spread to other parts of the body (localized). High-dose rate brachytherapy delivers radiation directly into the prostate within a few minutes by a single radioactive seed through temporarily placed plastic catheters inside the prostate gland. Stereotactic ablative radiotherapy is an external beam radiation method that delivers large doses of radiation to the cancer in a short period of time, usually 5 treatments. This trial aims to find which of these two approaches is better in terms of patient-reported quality of life.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess feasibility of a pilot non-randomized trial evaluating stereotactic ablative radiotherapy (SABR) and high-dose rate brachytherapy for localized prostate cancer.

OUTLINE: Patients elect to participate in arms 1 or 2.

ARM I: Patients undergo high-dose rate brachytherapy (HDR).

ARM II: Patients undergo SABR every other day for 5 treatments.

After completion of study treatment, patients are followed up periodically.

Being tested
High-Dose Rate Brachytherapy, Quality-of-Life Assessment, Questionnaire Administration, Stereotactic Ablative Radiotherapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-Dose Rate BrachytherapyRadiation

    Also called Brachytherapy, High Dose

    Undergo HDR

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Stereotactic Ablative RadiotherapyProcedure or surgery

    Also called SABR/SBRT

    Undergo SABR

Study groups in NCT04253483
Study groupRoleWhat they receive
Arm I (HDR)ExperimentalPatients undergo HDR.
Receives: Radiation: High-Dose Rate Brachytherapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm II (SABR)ExperimentalPatients undergo SABR every other day for 5 treatments.
Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Stereotactic Ablative Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of comparing stereotactic ablative radiotherapy (SABR) and high-dose rate brachytherapy (HDRB)

    Feasibility is defined as success in enrolling patients, performing the procedures, reporting adverse effects, collecting and managing data across several institutions and patient compliance in completing health-related quality of life questionnaires.

    Measured: 36 months

Secondary outcomes (4)

  1. Changes in patient reported Health-Related Quality of life (HRQoL)

    Will be assessed by the Expanded Prostate Cancer Index Composite (EPIC)-26 short form at baseline, 1,3,6,9,12,18,24 and 36 months.

    The response to each EPIC item is standardized to a 0 to 100 scale, with higher scores representing better quality of life. Each domain is then scored by adding the score of each item within the group divided by the total number of items. Since androgen-deprivation therapy is not permitted in our study, the hormonal score will not be reported. HRQoL scores in the bowel, sexual, urinary incontinence and irritative domains will be evaluated.

    Measured: Baseline up to 36 months

  2. Changes in patient-reported urinary toxicity

    Will be assessed by American Urology Association Symptom Score questionnaires (AUA) at baseline, 1,3,6,9,12,18,24 and 36 months.

    The AUA evaluates urinary function, 7 questions, total score is 35. The higher the score, the higher rate of urinary toxicity.

    Measured: Baseline up to 36 months

  3. Changes in patient-reported sexual toxicity

    Will be assessed by Sexual Health Inventory for Men (SHIM) questionnaires at baseline, 1,3,6,9,12,18,24 and 36 months.

    The SHIM, score 1-25 lower score reflecting severe erectile dysfunction.

    Measured: Baseline up to 36 months

  4. Incidence of adverse events

    Physician-reported adverse events using the Common Terminology Criteria for Adverse Events version 4.0 will be reported at baseline, 1,3,6,9,12,18,24 and 36 months at each patient visit.

    Measured: Baseline up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study start17 Jul 2019
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04253483
Sponsor's protocol ID
Pro2018002793
Other IDs
NCI-2020-00236, Pro2018002793, 081805, P30CA072720
Status last verified
Sep 2025
First submitted
28 Jan 2020
Last updated
17 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing High-Dose Rate Brachytherapy, Quality-of-Life Assessment and Questionnaire Administration in people with Stage I Prostate Cancer AJCC v8 and Stage II Prostate Cancer AJCC v8, run by Rutgers, The State University of New Jersey at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of comparing stereotactic ablative radiotherapy (SABR) and high-dose rate brachytherapy (HDRB) (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04253483.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.

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