No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Study type
Observational
Participants needed
200 (estimated)
Sponsor
Jonsson Comprehensive Cancer Center · Other
Who this trial is looking for
This trial is looking for men who have had surgery for prostate cancer and may still be at risk for cancer returning. Participants will receive targeted radiation therapy to help reduce side effects and improve quality of life.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with prostate cancer and had surgery.
I have one of the listed risk factors after my surgery.
I am 18 years old or older.
I can understand and sign a consent form.
I have had a CT scan or MRI of my pelvis within the last 120 days.
I have a bone scan or advanced imaging if my PSA is above 1.0 ng/mL.
My health status meets the study requirements.
You may not be able to join if
I have evidence of cancer that has spread to other parts of my body.
I have a history of neuroendocrine or small cell prostate cancer.
I have had previous radiation therapy to my pelvis.
I have Crohn's Disease, Ulcerative Colitis, or Ataxia Telangiectasia.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Single-arm, prospective registry study assessing changes in acute patient-reported urinary (GU) and gastrointestinal (GI) quality of life at the 24-month post-treatment time point following magnetic resonance imaging (MRI)-guided or computed tomography (CT)-guided stereotactic body radiotherapy (SBRT) delivered to the prostate bed +/- pelvic lymph nodes. The decision to offer an adaptive treatment…
Single-arm, prospective registry study assessing changes in acute patient-reported urinary (GU) and gastrointestinal (GI) quality of life at the 24-month post-treatment time point following magnetic resonance imaging (MRI)-guided or computed tomography (CT)-guided stereotactic body radiotherapy (SBRT) delivered to the prostate bed +/- pelvic lymph nodes. The decision to offer an adaptive treatment will be at the clinician's discretion.
Trial Locations
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Eligibility Criteria
Inclusion Criteria
* History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent.
* Presence of any ONE of the following:
1. Adverse pathologic features at the time of prostatectomy (positive surgical margin, pa…
Inclusion Criteria
* History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent.
* Presence of any ONE of the following:
1. Adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, OR presence of tertiary Gleason grade 5 disease)
2. Documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng/mL
3. Intermediate- or high-risk Decipher genomic classifier score
4. Identification of prostate cancer in ≥1 lymph node at the time of prostatectomy (pN+ disease)
* CT scan and MRI of the pelvis within 120 days prior to enrollment \[note: (a) if patient has medical contraindication to MRI, an exemption will be granted and enrollment can proceed; (b) for patients with PSA \<1.0 ng/mL, the treatment planning CT can substitute for a diagnostic CT scan; (c) a low-field, radiation planning MRI can replace the diagnostic MRI if the patient refuses or cannot obtain a high-field MRI\].
* Bone scan OR advanced nuclear imaging study within 120 days prior to enrollment for patients with PSA \>1.0 ng/mL.
* Age ≥ 18.
\~. KPS ≥ 70 and/or ECOG \<2.
* Ability to understand, and willingness to sign, the written informed consent
Exclusion Criteria
* Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator.
* Patients with neuroendocrine or small cell carcinoma of the prostate
* Prior pelvic radiotherapy
* History of Crohn's Disease, Ulcerative Colitis, or Ataxia Telangiectasia
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