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

NCT04915508 | Recruiting Phase 2 DMC FDA Device

• 2 other identifiers: 21-000263NCI-2021-05447
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline up to 2 years

• 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.

  Baseline up to 2 years

Secondary Outcomes (7)

• Patient-reported gastrointestinal (GI) symptoms

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

• Patient-reported genitourinary (GU) symptoms

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

• Incidence of acute physician scored adverse events

  Up to 5 years

• Cumulative incidence of physician scored adverse events

  Up to 5 years

• Progression-free survival

  Up to 5 years

Study Arms (1)

Treatment (SBRT, hormone therapy)

EXPERIMENTAL

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.

Drug: Hormone Therapy; Radiation: Stereotactic Body Radiation Therapy

Interventions

Hormone Therapy DRUG

Receive hormonal therapy

Also known as: Chemotherapy-Hormones/Steroids, Endocrine Therapy, Hormonal Therapy, hormone treatment

Treatment (SBRT, hormone therapy)

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Treatment (SBRT, hormone therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent
• Presence of any ONE of the following:
• 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
• 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
• Karnofsky performance status (KPS) \>= 70 and/or Eastern Cooperative Oncology Group (ECOG) =\< 2
• Ability to understand, and willingness to sign, the written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Steroids; Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Amar Kishan

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Carlton

CONTACT

(925)212-7215; bcarlton@mednet.ucla.edu

Vince Basehart

CONTACT

(310) 267-8954; vbasehart@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 7, 2021
• Study Start: June 23, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

US (1)