About this trial

This phase II trial investigates the effect of extremely hypofractionated intensity modulated stereotactic body radiotherapy in treating patients with prostate cancer that has rising prostate specific antigen (PSA) after radical prostatectomy. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent

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)

Documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng/mL

Intermediate- or high-risk Decipher genomic classifier score

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Hormone Therapy
Drug
Receive hormonal therapy
Stereotactic Body Radiation Therapy
Radiation
Undergo SBRT

Treatment groups

102 Participants

are divided into 1 treatment group

Group A: Treatment (SBRT, hormone therapy)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change of Expanded Prostate Cancer Index (EPIC) score for the gastrointestinal domain

EPIC assessed the disease-specific aspects of prostate cancer and its therapies within the gastrointestinal summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.

Time frame

Baseline up to 2 years

2

Change of Expanded Prostate Cancer Index (EPIC) score for the genitourinary domain

EPIC assessed the disease-specific aspects of prostate cancer and its therapies within the genitourinary summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.

Time frame

Baseline up to 2 years

Secondary outcomes

1

Patient-reported gastrointestinal (GI) symptoms

EPIC assessed the disease-specific aspects of prostate cancer and its therapies within the gastrointestinal summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.

Time frame

At 3 months, 6 months, 1year, and 5 years

2

Patient-reported genitourinary (GU) symptoms

EPIC assessed the disease-specific aspects of prostate cancer and its therapies within the genitourinary summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.

Time frame

At 3 months, 6 months, 1year, and 5 years

3

Incidence of acute physician scored adverse events

Will be assessed by using the Common Terminology Criteria for Adverse Events version 4.0.

Time frame

Up to 5 years

4

Cumulative incidence of physician scored adverse events

Will be assessed by using the Common Terminology Criteria for Adverse Events version 4.0.

Time frame

Up to 5 years

Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer With Rising PSA After Radical Prostatectomy

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts