Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-28

Study Completion Date

2023-01-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to test the safety and side effects "of "ultra-hypofractionated" radiation therapy when used after brachytherapy (radiation implants). This treatment delivers a higher radiation dose with each treatment over a shorter period of time.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Internal Radiation Therapy in Treating Patients With Prostate Cancer

NCT00573833

Prostate Cancer

COMPLETED NA

Internal Radiation Therapy With or Without External-Beam Radiation Therapy in Treating Patients With Localized Prostate Cancer

NCT00714753

Prostate Cancer

COMPLETED PHASE2

A Study of MRI-guided High-dose Radiation Therapy in Prostate Cancer

NCT04997018

Prostate Cancer

ACTIVE_NOT_RECRUITING PHASE2

Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage, Low Volume Prostate Cancer

NCT01354951

Prostate Cancer

TERMINATED PHASE2

High-dose Brachytherapy Boost With Stereostatic Body Radiation Therapy to Intermediate or Higher Risk Prostate Cancer

NCT05754580

Prostatic Cancer

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

radiation therapy in combination with brachytherapy

Patients will undergo low dose rate (LDR) prostate brachytherapy using Pd-103 followed approximately 4 weeks later with hypofractionated image-guided external beam radiation therapy (25Gy in 5 fractions; 5Gy x 5 fractions every other day) to the prostate \& seminal vesicles. Both brachytherapy as well as external beam will be performed according to our current standards of practice using the same equipment, techniques, \& treatment planning procedures. Pts will be followed post-treatment at 1, 3, 6 (+/- 4 weeks) \& every 6 months (+/- 4 weeks) thereafter until 36 months. During the post-treatment followup, pts will be evaluated for urinary, bowel/rectal \& sexual toxicity. Baseline measures of these domains will be obtained prior to treatment at the time of enrollment. Serum PSA levels will be drawn on the same schedule as clinical followup. Post-treatment prostate biopsies will be obtained once between 24-36 months post-treatment to evaluate pathologic response to therapy

Group Type EXPERIMENTAL

external beam radiation therapy

Intervention Type RADIATION

brachytherapy

Intervention Type RADIATION

questionnaires

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

external beam radiation therapy

Intervention Type RADIATION

brachytherapy

Intervention Type RADIATION

questionnaires

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

International Prostate Symptom Score International Index of Erectile Function-6 EPIC urinary, bowel and sexual domain

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Intermediate risk prostate cancer patients will be eligible for this study. Intermediate risk grouping will be assessed per NCCN guidelines as:
* Pathologically-proven diagnosis of prostate adenocarcinoma
* PSA 10-20ng/mL or
* Gleason =7 or
* Clinical stage T2b/c
* Clinical stage T2b/c Additionally, patients will be required to meet the following criteria
* Age ≥18
* KPS≥70
* Prostate volume ≤ 60cc (cytoreductive androgen deprivation therapy prior to brachytherapy of ≤ 6 months duration will be allowed to achieve this goal). For patients with a prostate volume between 50-60ccs, hormone therapy will be at the discretion of the physician.
* International Prostate Symptom Score ≤15

Exclusion Criteria

* Prior prostate surgery (including TURP)
* Prior history of chronic prostatitis or urethral stricture
* Inflammatory bowel disease
* Prior history of pelvic radiotherapy
* Unable to give informed consent
* Metastatic disease.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No