Description:
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.
Title
- Brief Title: Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer With Rising PSA After Radical Prostatectomy
- Official Title: Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for Adjuvant or Salvage Treatment for Rising PSA After Radical Prostatectomy (EXCALIBUR)
Clinical Trial IDs
- ORG STUDY ID:
21-000263
- SECONDARY ID:
NCI-2021-05447
- NCT ID:
NCT04915508
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
Interventions
Drug | Synonyms | Arms |
---|
Hormone Therapy | Chemotherapy-Hormones/Steroids, Endocrine Therapy, Hormonal Therapy, hormone treatment | Treatment (SBRT, hormone therapy) |
Purpose
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.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the two-year change in patient-reported gastrointestinal (GI) symptoms based
on the Expanded Prostate Cancer Index (EPIC) instrument following stereotactic body
radiotherapy (SBRT) to the prostate bed and/or pelvic lymph nodes, with a comparison to
historical control data for more prolonged radiation regimens.
II. To determine the two-year change in patient-reported urinary (GU) symptoms based on the
EPIC instrument following stereotactic body radiotherapy (SBRT) to the prostate bed and/or
pelvic lymph nodes, with a comparison to historical control data for more prolonged radiation
regimens.
SECONDARY OBJECTIVES:
I. To quantify patient-reported GI symptoms using the EPIC instrument at 3 months, 6 months,
1 and 5 years.
II. To quantify patient-reported GU symptoms using the EPIC instrument at 3 months, 6 months,
1 and 5 years.
III. To quantify rates and severity of acute physician scored adverse events using the Common
Terminology Criteria for Adverse Events (CTCAE version [v.] 5.0) scale.
IV. To quantify the five-year cumulative incidence of physician scored adverse events the
CTCAE v4.03 scale.
V. To quantify five-year progression-free survival. VI. To quantify 5-year cumulative
incidence of biochemical recurrence. VII. To quantify 5-year distant metastasis-free
survival.
EXPLORATORY OBJECTIVES:
I. To compare all primary and secondary endpoints between patients treated with an magnetic
resonance imaging (MRI)-guided versus a computed tomography (CT)-guided linear accelerator.
II. To compare primary and secondary endpoints between patients treated with short course (=<
6 months) or long-term >= 12 months) antiandrogen therapy (ADT).
OUTLINE:
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.
After completion of study treatment, patients are followed up every 3 months for the first
year, and then every 6 months for up to 5 years.
Trial Arms
Name | Type | Description | Interventions |
---|
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. | |
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:
- 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
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Change of Expanded Prostate Cancer Index (EPIC) score for the gastrointestinal domain |
Time Frame: | Baseline up to 2 years |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | Patient-reported gastrointestinal (GI) symptoms |
Time Frame: | At 3 months, 6 months, 1year, and 5 years |
Safety Issue: | |
Description: | 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. |
Measure: | Patient-reported genitourinary (GU) symptoms |
Time Frame: | At 3 months, 6 months, 1year, and 5 years |
Safety Issue: | |
Description: | 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. |
Measure: | Incidence of acute physician scored adverse events |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Will be assessed by using the Common Terminology Criteria for Adverse Events version 4.0. |
Measure: | Cumulative incidence of physician scored adverse events |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Will be assessed by using the Common Terminology Criteria for Adverse Events version 4.0. |
Measure: | Progression-free survival |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Cumulative incidence of biochemical recurrence |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Distant metastasis-free survival |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Jonsson Comprehensive Cancer Center |
Last Updated
July 2, 2021