Description:
This phase II trial studies how well surgery and radiation therapy work in treating patients
with prostate cancer that has come back or spread to other parts of the body. Radiation
therapy uses high energy beams to kill tumor cells and shrink tumors. Surgical procedures,
such as oligometastasectomy, may remove tumor cells that have spread to other parts of the
body. Surgery and radiation therapy may work better in treating patients with prostate cancer
that has come back or spread to other parts of the body.
Title
- Brief Title: Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer
- Official Title: Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer (SOAR)
Clinical Trial IDs
- ORG STUDY ID:
HCI115811
- SECONDARY ID:
NCI-2018-03418
- NCT ID:
NCT03796767
Conditions
- Recurrent Prostate Carcinoma
- Metastatic Malignant Neoplasm in the Bone
- Metastatic Malignant Neoplasm in the Lymph Nodes
- Oligometastasis
- Prostate Adenocarcinoma
- PSA Failure
Purpose
This phase II trial studies how well surgery and radiation therapy work in treating patients
with prostate cancer that has come back or spread to other parts of the body. Radiation
therapy uses high energy beams to kill tumor cells and shrink tumors. Surgical procedures,
such as oligometastasectomy, may remove tumor cells that have spread to other parts of the
body. Surgery and radiation therapy may work better in treating patients with prostate cancer
that has come back or spread to other parts of the body.
Detailed Description
PRIMARY OBJECTIVES:
I. To assess response to treatment of oligometastatic disease.
SECONDARY OBJECTIVES:
I. To assess additional measurements of response to treatment of oligometastatic disease.
II. To assess prostate-specific antigen (PSA) progression free-survival following treatment
of oligometastatic disease.
III. To assess time to disease recurrence following treatment of oligometastatic disease.
IV. To assess time to initiation of antiandrogen therapy (ADT) for metastatic prostate cancer
following treatment of oligometastatic disease.
V. To assess the rate of undetectable PSA following treatment of oligometastatic disease in
subjects who have previously undergone prostatectomy.
VI. To assess safety. VII. To assess the impact of study treatment on change in quality of
life over three years.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A (radiation therapy) | Experimental | Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. | |
Arm B (salvage oligometastasectomy) | Experimental | Patients with nodal metastases undergo salvage oligometastasectomy. | |
Arm C (salvage oligometastasectomy, radiation therapy) | Experimental | Patients with nodal metastases undergo salvage oligometastasectomy. Following recovery, patients undergo SBRT or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. Within 4 months following completion of salvage therapy (defined as the combination of oligometastasectomy and/or bone radiation) and depending on PSA response as well as previous treatment, patients may receive adjuvant nodal IMRT. | |
Eligibility Criteria
Inclusion Criteria:
- Histologically proven adenocarcinoma of the prostate.
- Recurrent prostate carcinoma after definitive therapy for primary disease defined as:
- Post-prostatectomy (with/without adjuvant radiotherapy): Detectable or rising PSA
level that is > 0.2 ng/mL with a second confirmatory level of > 0.2 ng/mL after a
minimum of 1 week.
- Post radiotherapy/ablation (without radical prostatectomy): PSA rise >= 2ng/mL
over nadir.
- Subjects treated with prior definitive radiotherapy for prostate cancer who have
positive molecular imaging (e.g., fluciclovine PET/CT scan or other per PI discretion)
suggesting recurrent intraprostatic disease must undergo transrectal ultrasound (TRUS)
biopsy less than or equal to one year before study enrollment:
- If the TRUS biopsy is negative, no additional treatment is required to the
prostate in addition to that of scan positive sites.
- If the TRUS biopsy is positive, subject must undergo salvage prostatectomy or
salvage radiotherapy to the primary site concurrently with the study treatment
per the treatment protocol algorithm.
- Oligometastatic disease defined as 10 or fewer metastatic lesions to lymph nodes
and/or bones only.
- For patients with oligometastatic disease involving lymph nodes, metastasis is
confined to the pelvic or para-aortic (below IMA) regions on molecular imaging (e.g.,
fluciclovine PET/CT or PSMA PET/CT scan or other per PI discretion).
- All subjects must be surgical candidates if surgery is indicated per the treatment
algorithm.
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2.
- Use of condoms for male subjects who have not had surgical removal of their prostate
and have a partner of child bearing potential beginning at the time of informed
consent form (ICF) signature and lasting until at least 6 months after the last
radiation treatment. Because of the potential side effect on spermatogenesis
associated with radiation, female partners of childbearing potential must agree to use
a highly effective contraceptive method during and for 6 months after completing
treatment.
- Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events
(CTCAE) version (v)5 from toxicities related to any prior treatments, unless adverse
event (AE)(s) are clinically non-significant and/or stable on supportive therapy as
determined by the treating physician.
- Able to provide informed consent and willing to sign an approved consent form that
conforms to federal and institutional guidelines.
Exclusion Criteria:
- Known brain or visceral metastases other than lymph nodes as defined by CT, MRI, or
othermolecular imaging (e.g., fluciclovine PET/CT or PSMA PET/CT scan or other per PI
discretion).
- Patients actively receiving hormone therapy for prostate cancer. Patients may have
received hormone therapy perviously but must have documented non-castrate levels of
testosterone (>50 ng/dL)
- Prior or concurrent malignancy whose natural history or treatment, in the opinion of
the enrolling investigator, may have the potential to interfere wih the safety or
efficay assessment of the investigational treatment protocol of the study.
- Use of finasteride within 30 days prior to initiation of therapy. Baseline PSA should
not be obtained prior to 30 days after stopping finasteride.
- Use of dutasteride within 90 days prior to initiation of therapy. Baseline PSA should
not be obtained prior to 90 days after stopping dutasteride.
- Use of any prohibited therapy.
- Active, uncontrolled, significant intercurrent or recent illness including, but not
limited to, the following conditions:
- Cardiovascular disorders:
- Congestive heart failure New York Heart Association class 3 or 4, unstable
angina pectoris, serious cardiac arrhythmias.
- Uncontrolled hypertension defined as sustained blood pressure (BP) > 150
mmHg systolic or > 100 mmHg diastolic despite optimal antihypertensive
treatment.
- Stroke (including transient ischemic attack [TIA]), myocardial infarction
(MI), or other ischemic event, or thromboembolic event (e.g., deep venous
thrombosis, pulmonary embolism) within 6 months before first dose.
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time
of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of registration
or within 30 days of registration.
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Prostate-specific antigen (PSA) response rate |
Time Frame: | At 6 months after completion of treatment |
Safety Issue: | |
Description: | Defined according to Prostate Cancer Working Group (PCWG3) criteria as the proportion of patients achieving a PSA decline >= 50% at 6 months after completion of treatment (salvage + - adjuvant). All study data will use descriptive statistics and will be exploratory only. |
Secondary Outcome Measures
Measure: | PSA progression-free survival (PFS) |
Time Frame: | Time elapsed between completion of treatment (salvage + - adjuvant) and the first occurrence of confirmed PSA progression, assessed up to 3 years |
Safety Issue: | |
Description: | Assessed according to PCWG3 criteria. All study data will use descriptive statistics and will be exploratory only. |
Measure: | Time to disease recurrence |
Time Frame: | Time elapsed between study enrollment and first occurrence of confirmed radiographic disease progression, assessed up to 3 years |
Safety Issue: | |
Description: | Time from study enrollment until the date of confirmed radiographic disease progression as defined by RECIST 1.1 and PCWG3. |
Measure: | Time to antiandrogen therapy (ADT) |
Time Frame: | Time elapsed between study enrollment and initiation of ADT up to 3 years |
Safety Issue: | |
Description: | All study data will use descriptive statistics and will be exploratory only. |
Measure: | Rate of undetectable PSA |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | Patients previously treated with prostatectomy evaluate the proportion of patients whose PSA remains =< 0.2 ng/mL after 6 and 12 months following completion of treatment (salvage + - adjuvant). All study data will use descriptive statistics and will be exploratory only. |
Measure: | Incidence of adverse events |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. All study data will use descriptive statistics and will be exploratory only. |
Measure: | Assess impact of study treatment on Change in quality of life over 3 years |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | Quality of Life (QOL) questionnaires (FACT-P and Expanded Prostate Cancer Index Composite EPIC-26) administered at screening, response assessment visit, and each follow up visit. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | University of Utah |
Last Updated
October 29, 2020