Radiotherapy for Oligometastatic Prostate Cancer

University of Florida

Status: Completed

Conditions: Oligometastatic Prostate Cancer

Treatments: Radiation: Stereotactic radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT01859221

UFPTI 1301-OL01

IRB201702654 (Other Identifier)

Details and patient eligibility

About

The purpose of this phase II study is to evaluate the outcomes of patients treated with an investigational radiation regimen using stereotactic radiotherapy for oligometastatic prostate cancer and to establish efficacy (producing a desired result or effect) and safety in this setting.

Full description

This study will serve as a component of a larger program investigating the benefits of stereotactic radiotherapy in patients with metastatic disease.

This particular study will serve as a benchmark analysis.

All patients will receive stereotactic radiotherapy directed at metastatic tumors.

If primary prostate cancer is active and has not previously been treated with radiation therapy, conventional radiation therapy (6-8 weeks of daily treatment) may be recommended. The metastatic tumor will be treated at the same time.

Hormone therapy will be recommended for all patients.

Patients will be asked to complete questionnaires at regular intervals.

Enrollment: 39 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with metastatic cancer of the prostate,
• Patients may have received prior surgery,
• Prior radiation therapy, androgen deprivation therapy (ADT), immunotherapy, bone metastasis directed therapy, or chemotherapy for prostate cancer.

Exclusion criteria

• End-stage heart disease,
• End-stage liver disease,
• End-stage renal disease,
• End stage pulmonary disease
• Current brain or central nervous system metastasis.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Castration Resistant

Experimental group

Description:

There are two different prognostic categories, hormones receptive and castration resistant, that have differing historical disease progression rates. We have therefore stratified the trial so that we can independently monitor the hypothesized improvement provided by radiation therapy in these two groups. Both groups will receive the same radiation modality which is interventional stereotactic radiation with two possible schedules of SBRT and SHRT.

Treatment:

Radiation: Stereotactic radiation

Hormone Receptive

Experimental group

Description:

There are two different prognostic categories, hormones receptive and castration resistant, that have differing historical disease progression rates. We have therefore stratified the trial so that we can independently monitor the hypothesized improvement provided by radiation therapy in these two groups. Both groups will receive the same radiation modality which is interventional stereotactic radiation with two possible schedules of SBRT and SHRT.

Treatment:

Radiation: Stereotactic radiation