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

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participants needed

10
sponsor

Rutgers, The State University of New Jersey

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Updated on 19 February 2024

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cancer

ct scan

computed tomography

treatment regimen

adenocarcinoma

MRI

prostate adenocarcinoma

prostate specific antigen

bone scan

brachytherapy

prostate biopsy

transrectal ultrasound

external beam radiation therapy

alpha blocker

protocol treatment

rectal ultrasound

antiandrogen therapy

adenocarcinoma of prostate

androgen suppression

androgen deprivation therapy

prostate-specific antigen

stage ii prostate cancer

adjuvant

prostate cancer

stereotactic ablative radiotherapy

trus

stage iia prostate cancer ajcc v8

stage iic prostate cancer ajcc v8

stage i prostate cancer ajcc v8

stage iia prostate cancer

stage i prostate cancer

stage iib prostate cancer

stage ii prostate cancer ajcc v8

stage iib prostate cancer ajcc v8

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). 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.

Description

PRIMARY OBJECTIVE:

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

OUTLINE: Patients are randomized to 1 of 2 arms.

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.

Details

Condition	Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8
Age	18years - 100years
Treatment	Questionnaire Administration, Quality-of-Life Assessment, High-Dose Rate Brachytherapy, Stereotactic Ablative Radiotherapy
Clinical Study Identifier	NCT04253483
Sponsor	Rutgers, The State University of New Jersey
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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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external beam radiation therapy

adenocarcinoma of prostate

androgen suppression

androgen deprivation therapy

prostate-specific antigen

stage ii prostate cancer

adjuvant

prostate cancer

stereotactic ablative radiotherapy

trus

stage iia prostate cancer ajcc v8

stage iic prostate cancer ajcc v8

stage i prostate cancer ajcc v8

stage iia prostate cancer

stage i prostate cancer

stage iib prostate cancer

stage ii prostate cancer ajcc v8

stage iib prostate cancer ajcc v8

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