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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT04915508
Phase
PHASE2
Status
Recruiting
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Conditions

  • Prostate Adenocarcinoma
  • Stage IIIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8
  • Stage IIIC Prostate Cancer AJCC v8
  • Stage IV Prostate Cancer AJCC v8
  • Stage IVA Prostate Cancer AJCC v8
  • Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hormone Therapy — DRUG
    Receive hormonal therapy
  • Stereotactic Body Radiation Therapy — RADIATION
    Undergo SBRT

Study Details

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.

Key Dates

Start date
Jun 23, 2021
Status verified
Jun 2025
Primary completion
Aug 1, 2026
Completion
Aug 1, 2027

Study Design

Enrollment
102 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (SBRT, hormone therapy)
    Patients undergo SBRT every other day or on consecutive days for up to 14 days. Patients may receive hormonal therapy at the discretion of the treating physician.

Primary Outcome Measure

Change of Expanded Prostate Cancer Index (EPIC) score for the gastrointestinal domain [ Time Frame: Baseline up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095
Brian Carlton
[email protected]
(925) 212-7215
Vince Basehart
[email protected]
(310) 267-8954
Amar Kishan, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CA

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