Study on Using Targeted Radiation Therapy for Prostate Cancer with Rising PSA Levels After Surgery

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40

Inactive

ClinicalTrials ID:NCT04915508

This clinical trial is exploring a new radiation therapy method for treating prostate cancer in patients whose PSA levels are increasing after surgery. The study aims to see if this precise radiation treatment can effectively target cancer cells with fewer side effects.

Patient Parameters

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Program Overview

This study is testing a new type of radiation therapy called extremely hypofractionated intensity modulated stereotactic body radiotherapy (SBRT) for prostate cancer patients whose PSA levels are rising after surgery. This advanced radiation technique uses special equipment to deliver high doses of radiation directly to the tumor with great precision, potentially killing cancer cells more effectively and with fewer treatments. The goal is to see if this method can reduce side effects and improve outcomes compared to traditional radiation therapy.

Description

Primary Objectives:

To assess changes in gastrointestinal (GI) symptoms reported by patients over two years after receiving SBRT to the prostate area, compared to past data from longer radiation treatments.
To assess changes in urinary (GU) symptoms reported by patients over two years after receiving SBRT to the prostate area, compared to past data from longer radiation treatments.

Secondary Objectives:

To measure patient-reported GI symptoms at 3 months, 6 months, 1 year, and 5 years using a specific questionnaire.
To measure patient-reported GU symptoms at 3 months, 6 months, 1 year, and 5 years using a specific questionnaire.
To record and evaluate any immediate side effects using a standard scale.
To track the occurrence of side effects over five years using a standard scale.
To monitor the five-year progression-free survival rate.
To track the five-year rate of cancer recurrence based on PSA levels.
To monitor the five-year rate of survival without cancer spreading to distant parts of the body.

Exploratory Objectives:

To compare outcomes between patients treated with MRI-guided versus CT-guided radiation machines.
To compare outcomes between patients receiving short-term (up to 6 months) versus long-term (12 months or more) hormone therapy.

Outline:

Patients will receive SBRT every other day or on consecutive days for up to 14 days. Hormone therapy may be given based on the doctor's decision. After treatment, patients will have follow-up visits every 3 months for the first year, then every 6 months for up to 5 years.

Eligibility Criteria

Inclusion Criteria

Have a history of prostate cancer confirmed by lab tests and treated with surgery.
Meet at least one of the following conditions:
- Had certain adverse features found during surgery, such as positive surgical margins or high Gleason scores.
- Have rising PSA levels on at least two tests, with levels above 0.03 ng/mL.
- Have an intermediate or high-risk score on a specific genomic test.
- Have cancer found in one or more lymph nodes during surgery.
Have had a CT scan and MRI of the pelvis within 120 days before joining the study. Exceptions apply for certain medical conditions or if PSA is below 1.0 ng/mL.
Have had a bone scan or advanced imaging study within 120 days before joining the study if PSA is above 1.0 ng/mL.
Be 18 years or older.
Have a performance status score indicating they are able to carry out daily activities.
Be able to understand and willing to sign the consent form.

Exclusion Criteria

Have evidence of cancer spread to distant parts of the body, except for certain lymph node involvement.
Have neuroendocrine or small cell prostate cancer.
Have had previous radiation therapy to the pelvic area.
Have a history of Crohn's disease, ulcerative colitis, or ataxia telangiectasia.

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