Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer

Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer (SOAR)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03796767

Acronym

SOAR

Enrollment

Registered

2019-01-08

Start date

2019-09-09

Completion date

2026-06-30

Last updated

2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Prostate Carcinoma, Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Neoplasm in the Lymph Nodes, Oligometastasis, Prostate Adenocarcinoma, PSA Failure

Brief summary

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.

Interventions

RADIATIONHypofractionated Radiation Therapy

Undergo hypofractionated radiation therapy

RADIATIONIntensity-Modulated Radiation Therapy

Undergo IMRT

PROCEDUREMetastasectomy

Undergo salvage oligometastasectomy

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

RADIATIONStereotactic Body Radiation Therapy

Undergo SBRT

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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): Patients must have a detectable or rising PSA level that is \> 0.05 ng/mL, with a second confirmatory level of \> 0.05 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. * NOTE: Biopsy is not required for prostate fossa recurrences after radical prostatectomy. * 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.

Design outcomes

Primary

Measure	Time frame	Description
Prostate-specific Antigen (PSA) ≥ 50% 6 Months After Completion of All Treatment	6 months after completion of 5-21 weeks of treatment	The primary outcome measure will report the count of patients achieving a PSA decline \>= 50% at 6 months after completion of treatment (salvage + - adjuvant). Prostate-Specific Antigen (PSA) is a protein produced by tissue in the prostate. An elevated PSA value can be a sign of prostate cancer.

Secondary

Measure	Time frame	Description
Prostate-specific Antigen (PSA) ≥ 50% 12 Months After Completion of All Treatment	12 months after completion of 5-21 weeks of treatment	Defined according to Prostate Cancer Working Group (PCWG3) criteria as the proportion of patients achieving a PSA decline \>= 50% at 12 months after completion of treatment (salvage + - adjuvant). Prostate-Specific Antigen (PSA) is a protein produced by tissue in the prostate. An elevated PSA value can be a sign of prostate cancer.
PSA Progression Free-survival	Time elapsed between study enrollment and first occurrence of confirmed radiographic disease progression, assessed up to 3 years	The proportion of subjects without PSA progression (defined using Prostate Cancer Working Group 3 Criteria PCWG3), evaluated every 3 months for 3 years after completion of all treatment (salvage and adjuvant therapy).
To Assess Time to Disease Recurrence Following Treatment of Oligometastatic Disease.	Time elapsed between study enrollment and confirmed radiographic disease progression, up to 3 years	The time from study enrollment until the date of confirmed radiographic disease progression as defined by RECIST 1.1 and PCWG3.
To Assess Time to Initiation of ADT for Metastatic Prostate Cancer Following Treatment of Oligometastatic Disease.	Up to 3 years	The time from study enrollment to the initiation of ADT
Undetectable PSA	6 and 12 months after completion of 5-21 weeks of treatment	This outcome measure will report the count of participants with undetectable PSA after 6 and 12 months following completion of treatment (salvage ± adjuvant). Undetectable PSA is defined as the number of patients ever treated with prostatectomy whose PSA remains ≤ 0.2 ng/mL.
Number of Participants With Adverse Events (AE) by Grade	Up to 12 months after completion of 5-21 weeks of treatment	This outcome measure will assess the safety and tolerability of the study treatment. The severity of AEs was assessed using CTCAE v5.0 criteria, a 1-5 scale with higher numbers indicating greater severity. Grade 1 indicates "mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated" and Grade 5 indicates "death related to AE". This outcome measure will report the count of participants who experienced each AE grade. Subjects were monitored for adverse events from the start of treatment until 28 days after the last dose of the study drug. Adverse events were collected every three months for one year after treatment discontinuation.
Quality of Life (QOL) - The Functional Assessment of Cancer Therapy - Prostate (FACT-P)	up to 45 days after the initiation of study therapy	FACT-P is a QOL questionnaires administered at the Response Assessment Visit. FACT-P is used to assess the health-related QOL in prostate cancer. Patients indicate which symptoms/problems they've experienced during the past week, from 1 Not at All to 4 Very Much. The assessment was scored according to the "FACT-P Scoring Guidelines (Version 4)". Individual items that were "reverse items" (high value indicates poor QOL) were subtracted from 4; reverse and normal items were added to calculate each subscale. The higher the subscale the better the QOL. The subscales and score ranges are: Physical Well-Being (0-28), Social/ Family Well Being (0-28), Emotional Well-Being (0-24), Functional Well Being (0-28), and Prostate Cancer Subscale (0-48) This outcome will report the mean score and 95% confidence interval of each subscale.
Prostate-specific Antigen (PSA) ≥ 90%	6 and 12 months after completion of 5-21 weeks of treatment 6 Months After Completion of All Treatment6 Months After Completion of All Treatment	This outcome will report the count of patients achieving a PSA decline ≥ 90% 6 at 6 and12 months after completion of treatment (salvage + - adjuvant). Prostate-Specific Antigen (PSA) is a protein produced by tissue in the prostate. An elevated PSA value can be a sign of prostate cancer.
Quality of Life (QOL): Expanded Prostate Cancer Index Composite (EPIC-26)	up to 45 days after initiation of study therapy	EPIC-26 is a Health Related Quality of Life (HRQOL) questionnaires assessing the disease-specific aspects of prostate cancer and its therapies. This questionnaire asks patients to rank symptoms from 1 More than once a day to 5 Rarely or never. EPOC-26 reports 5 subscales: Urinary Incontinence Score, Urinary Obstructive/ Irritative Score, Bowel Score, Sexual Score, and Urinary Incontinence Score. Multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAlejandro Sanchez

Huntsman Cancer Institute/ University of Utah

Participant flow

Participants by arm

Arm	Count
Arm A (Radiation Therapy) Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT	2
Arm B (Salvage Oligometastasectomy) Patients with nodal metastases undergo salvage oligometastasectomy. Metastasectomy: Undergo salvage oligometastasectomy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	18
Arm C (Salvage Oligometastasectomy, Radiation Therapy) 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. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Intensity-Modulated Radiation Therapy: Undergo IMRT Metastasectomy: Undergo salvage oligometastasectomy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT	0
Total	20

Baseline characteristics

Characteristic	Arm A (Radiation Therapy)	Arm B (Salvage Oligometastasectomy)	Arm C (Salvage Oligometastasectomy, Radiation Therapy)	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	10 Participants	0 Participants	10 Participants
Age, Categorical Between 18 and 65 years	2 Participants	8 Participants	0 Participants	10 Participants
Age, Continuous	61.50 Years STANDARD_DEVIATION 0.71	66.50 Years STANDARD_DEVIATION 6.84	—	66.00 Years STANDARD_DEVIATION 6.66
BMI	26.35 kg/m^2 STANDARD_DEVIATION 2.11	29.43 kg/m^2 STANDARD_DEVIATION 3.27	—	29.12 kg/m^2 STANDARD_DEVIATION 3.27
ECOG 0 Fully active	1 Participants	18 Participants	0 Participants	19 Participants
ECOG 1 Restricted	1 Participants	0 Participants	0 Participants	1 Participants
ECOG 2 Ambulatory	0 Participants	0 Participants	0 Participants	0 Participants
ECOG 3 Limited selfcare	0 Participants	0 Participants	0 Participants	0 Participants
ECOG 4 Completely disabled	0 Participants	0 Participants	0 Participants	0 Participants
ECOG 5 Dead	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	1 Participants	0 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants	17 Participants	0 Participants	18 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Height	173.9 cm STANDARD_DEVIATION 5.39	177.78 cm STANDARD_DEVIATION 7.32	—	177.40 cm STANDARD_DEVIATION 7.13
Histology Adenocarcinoma of the prostate	2 Participants	18 Participants	0 Participants	20 Participants
Histology Adenocarcinoma of the prostate + secondary histology	0 Participants	0 Participants	0 Participants	0 Participants
M Stage M0	2 Participants	6 Participants	0 Participants	8 Participants
M Stage M1	0 Participants	0 Participants	0 Participants	0 Participants
M Stage Unknown / Not assessed	0 Participants	12 Participants	0 Participants	12 Participants
N Stage N0	2 Participants	11 Participants	0 Participants	13 Participants
N Stage N1	0 Participants	5 Participants	0 Participants	5 Participants
N Stage NX (regional lymph nodes cannot be assessed)	0 Participants	1 Participants	0 Participants	1 Participants
N Stage Unknown / Not assessed	0 Participants	1 Participants	0 Participants	1 Participants
Number of Nodal Lesions Present	0 Lesions	2.06 Lesions	—	1.85 Lesions
Overall Stage Stage IIB	0 Participants	3 Participants	0 Participants	3 Participants
Overall Stage Stage IIIA	0 Participants	2 Participants	0 Participants	2 Participants
Overall Stage Stage IIIB	2 Participants	1 Participants	0 Participants	3 Participants
Overall Stage Stage IIIC	0 Participants	2 Participants	0 Participants	2 Participants
Overall Stage Stage IVA	0 Participants	2 Participants	0 Participants	2 Participants
Overall Stage Stage IVB	0 Participants	1 Participants	0 Participants	1 Participants
Overall Stage Unknown / Not assessed	0 Participants	7 Participants	0 Participants	7 Participants
Prior exposer to Androgen deprivation therapy (ADT) No	1 Participants	13 Participants	0 Participants	14 Participants
Prior exposer to Androgen deprivation therapy (ADT) Yes	1 Participants	5 Participants	0 Participants	6 Participants
Prior radiotherapy Adjuvant/Salvage Radiotherapy - Pelvis + Prostate	2 Participants	1 Participants	0 Participants	3 Participants
Prior radiotherapy Adjuvant/Salvage Radiotherapy - Prostate	0 Participants	4 Participants	0 Participants	4 Participants
Prior radiotherapy Definitive Radiotherapy - Prostate (should be salvage radiation - prostate)	0 Participants	2 Participants	0 Participants	2 Participants
Prior radiotherapy None	0 Participants	11 Participants	0 Participants	11 Participants
PSA at Time of Initial Definitive Treatment	9.80 ng/mL STANDARD_DEVIATION 7.78	9.18 ng/mL STANDARD_DEVIATION 14.01	—	9.24 ng/mL STANDARD_DEVIATION 13.37
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	0 Participants	2 Participants
Race (NIH/OMB) White	1 Participants	17 Participants	0 Participants	18 Participants
Region of Enrollment United States	2 participants	18 participants	—	20 participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	2 Participants	18 Participants	0 Participants	20 Participants
Total Gleason at Definitive Treatment 6	0 Participants	1 Participants	0 Participants	1 Participants
Total Gleason at Definitive Treatment 7	1 Participants	13 Participants	0 Participants	14 Participants
Total Gleason at Definitive Treatment 8	1 Participants	1 Participants	0 Participants	2 Participants
Total Gleason at Definitive Treatment 9	0 Participants	3 Participants	0 Participants	3 Participants
T Stage T2	0 Participants	2 Participants	0 Participants	2 Participants
T Stage T2a	0 Participants	0 Participants	0 Participants	0 Participants
T Stage T2b	0 Participants	0 Participants	0 Participants	0 Participants
T Stage T2c	0 Participants	5 Participants	0 Participants	5 Participants
T Stage T3	0 Participants	0 Participants	0 Participants	0 Participants
T Stage T3a	2 Participants	6 Participants	0 Participants	8 Participants
T Stage T3b	0 Participants	5 Participants	0 Participants	5 Participants
Weight	180.00 kg STANDARD_DEVIATION 11.31	93.02 kg STANDARD_DEVIATION 11.94	—	91.72 kg STANDARD_DEVIATION 12.26

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 2	0 / 18	0 / 0
other Total, other adverse events	2 / 2	12 / 18	0 / 0
serious Total, serious adverse events	0 / 2	0 / 18	0 / 0

Outcome results

Primary

Prostate-specific Antigen (PSA) ≥ 50% 6 Months After Completion of All Treatment

The primary outcome measure will report the count of patients achieving a PSA decline \>= 50% at 6 months after completion of treatment (salvage + - adjuvant). Prostate-Specific Antigen (PSA) is a protein produced by tissue in the prostate. An elevated PSA value can be a sign of prostate cancer.

Time frame: 6 months after completion of 5-21 weeks of treatment

Population: No participants were enrolled in Arm C.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Arm A (Radiation Therapy)	Prostate-specific Antigen (PSA) ≥ 50% 6 Months After Completion of All Treatment	Yes	0 Participants
Arm A (Radiation Therapy)	Prostate-specific Antigen (PSA) ≥ 50% 6 Months After Completion of All Treatment	No	2 Participants
Arm B (Salvage Oligometastasectomy)	Prostate-specific Antigen (PSA) ≥ 50% 6 Months After Completion of All Treatment	Yes	8 Participants
Arm B (Salvage Oligometastasectomy)	Prostate-specific Antigen (PSA) ≥ 50% 6 Months After Completion of All Treatment	No	10 Participants
Arm C (Salvage Oligometastasectomy, Radiation Therapy)	Prostate-specific Antigen (PSA) ≥ 50% 6 Months After Completion of All Treatment	Yes	0 Participants
Arm C (Salvage Oligometastasectomy, Radiation Therapy)	Prostate-specific Antigen (PSA) ≥ 50% 6 Months After Completion of All Treatment	No	0 Participants

Secondary

Number of Participants With Adverse Events (AE) by Grade

This outcome measure will assess the safety and tolerability of the study treatment. The severity of AEs was assessed using CTCAE v5.0 criteria, a 1-5 scale with higher numbers indicating greater severity. Grade 1 indicates mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated and Grade 5 indicates death related to AE. This outcome measure will report the count of participants who experienced each AE grade. Subjects were monitored for adverse events from the start of treatment until 28 days after the last dose of the study drug. Adverse events were collected every three months for one year after treatment discontinuation.

Time frame: Up to 12 months after completion of 5-21 weeks of treatment

Population: No participants were enrolled in Arm C.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Arm A (Radiation Therapy)	Number of Participants With Adverse Events (AE) by Grade	CTCAE Grade: 4	0 Participants
Arm A (Radiation Therapy)	Number of Participants With Adverse Events (AE) by Grade	CTCAE Grade: 1	1 Participants
Arm A (Radiation Therapy)	Number of Participants With Adverse Events (AE) by Grade	CTCAE Grade: 2	1 Participants
Arm A (Radiation Therapy)	Number of Participants With Adverse Events (AE) by Grade	CTCAE Grade: 3	0 Participants
Arm A (Radiation Therapy)	Number of Participants With Adverse Events (AE) by Grade	CTCAE Grade: 5	0 Participants
Arm B (Salvage Oligometastasectomy)	Number of Participants With Adverse Events (AE) by Grade	CTCAE Grade: 5	0 Participants
Arm B (Salvage Oligometastasectomy)	Number of Participants With Adverse Events (AE) by Grade	CTCAE Grade: 3	0 Participants
Arm B (Salvage Oligometastasectomy)	Number of Participants With Adverse Events (AE) by Grade	CTCAE Grade: 1	11 Participants
Arm B (Salvage Oligometastasectomy)	Number of Participants With Adverse Events (AE) by Grade	CTCAE Grade: 4	0 Participants
Arm B (Salvage Oligometastasectomy)	Number of Participants With Adverse Events (AE) by Grade	CTCAE Grade: 2	3 Participants

Secondary

Prostate-specific Antigen (PSA) ≥ 50% 12 Months After Completion of All Treatment

Defined according to Prostate Cancer Working Group (PCWG3) criteria as the proportion of patients achieving a PSA decline \>= 50% at 12 months after completion of treatment (salvage + - adjuvant). Prostate-Specific Antigen (PSA) is a protein produced by tissue in the prostate. An elevated PSA value can be a sign of prostate cancer.

Time frame: 12 months after completion of 5-21 weeks of treatment

Population: No participant was enrolled on Arm C

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Arm A (Radiation Therapy)	Prostate-specific Antigen (PSA) ≥ 50% 12 Months After Completion of All Treatment	Yes	1 Participants
Arm A (Radiation Therapy)	Prostate-specific Antigen (PSA) ≥ 50% 12 Months After Completion of All Treatment	No	1 Participants
Arm B (Salvage Oligometastasectomy)	Prostate-specific Antigen (PSA) ≥ 50% 12 Months After Completion of All Treatment	Yes	4 Participants
Arm B (Salvage Oligometastasectomy)	Prostate-specific Antigen (PSA) ≥ 50% 12 Months After Completion of All Treatment	No	14 Participants
Arm C (Salvage Oligometastasectomy, Radiation Therapy)	Prostate-specific Antigen (PSA) ≥ 50% 12 Months After Completion of All Treatment	Yes	0 Participants
Arm C (Salvage Oligometastasectomy, Radiation Therapy)	Prostate-specific Antigen (PSA) ≥ 50% 12 Months After Completion of All Treatment	No	0 Participants

Secondary

Prostate-specific Antigen (PSA) ≥ 90%

This outcome will report the count of patients achieving a PSA decline ≥ 90% 6 at 6 and12 months after completion of treatment (salvage + - adjuvant). Prostate-Specific Antigen (PSA) is a protein produced by tissue in the prostate. An elevated PSA value can be a sign of prostate cancer.

Time frame: 6 and 12 months after completion of 5-21 weeks of treatment 6 Months After Completion of All Treatment6 Months After Completion of All Treatment

Population: No participants were enrolled in Arm C.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Arm A (Radiation Therapy)	Prostate-specific Antigen (PSA) ≥ 90%	PSA decline ≥ 90% at 6 Months	Yes	0 Participants
Arm A (Radiation Therapy)	Prostate-specific Antigen (PSA) ≥ 90%	PSA decline ≥ 90% at 6 Months	No	2 Participants
Arm A (Radiation Therapy)	Prostate-specific Antigen (PSA) ≥ 90%	PSA decline ≥ 90% at 12 Months	Yes	0 Participants
Arm A (Radiation Therapy)	Prostate-specific Antigen (PSA) ≥ 90%	PSA decline ≥ 90% at 12 Months	No	2 Participants
Arm B (Salvage Oligometastasectomy)	Prostate-specific Antigen (PSA) ≥ 90%	PSA decline ≥ 90% at 12 Months	No	14 Participants
Arm B (Salvage Oligometastasectomy)	Prostate-specific Antigen (PSA) ≥ 90%	PSA decline ≥ 90% at 6 Months	Yes	5 Participants
Arm B (Salvage Oligometastasectomy)	Prostate-specific Antigen (PSA) ≥ 90%	PSA decline ≥ 90% at 12 Months	Yes	4 Participants
Arm B (Salvage Oligometastasectomy)	Prostate-specific Antigen (PSA) ≥ 90%	PSA decline ≥ 90% at 6 Months	No	13 Participants
Arm C (Salvage Oligometastasectomy, Radiation Therapy)	Prostate-specific Antigen (PSA) ≥ 90%	PSA decline ≥ 90% at 12 Months	No	0 Participants
Arm C (Salvage Oligometastasectomy, Radiation Therapy)	Prostate-specific Antigen (PSA) ≥ 90%	PSA decline ≥ 90% at 6 Months	No	0 Participants
Arm C (Salvage Oligometastasectomy, Radiation Therapy)	Prostate-specific Antigen (PSA) ≥ 90%	PSA decline ≥ 90% at 12 Months	Yes	0 Participants
Arm C (Salvage Oligometastasectomy, Radiation Therapy)	Prostate-specific Antigen (PSA) ≥ 90%	PSA decline ≥ 90% at 6 Months	Yes	0 Participants

Secondary

PSA Progression Free-survival

The proportion of subjects without PSA progression (defined using Prostate Cancer Working Group 3 Criteria PCWG3), evaluated every 3 months for 3 years after completion of all treatment (salvage and adjuvant therapy).

Time frame: Time elapsed between study enrollment and first occurrence of confirmed radiographic disease progression, assessed up to 3 years

Secondary

Quality of Life (QOL): Expanded Prostate Cancer Index Composite (EPIC-26)

EPIC-26 is a Health Related Quality of Life (HRQOL) questionnaires assessing the disease-specific aspects of prostate cancer and its therapies. This questionnaire asks patients to rank symptoms from 1 More than once a day to 5 Rarely or never. EPOC-26 reports 5 subscales: Urinary Incontinence Score, Urinary Obstructive/ Irritative Score, Bowel Score, Sexual Score, and Urinary Incontinence Score. Multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.

Time frame: up to 45 days after initiation of study therapy

Population: 1 participant did not complete this assessment in Arm A. 10 participants did not complete this assessment in Arm B. No participants were enrolled in Arm C.

Arm	Measure	Group	Value (MEAN)
Arm A (Radiation Therapy)	Quality of Life (QOL): Expanded Prostate Cancer Index Composite (EPIC-26)	EPIC-26: Urinary Obstructive/ Irritative Score	75 units on a scale
Arm A (Radiation Therapy)	Quality of Life (QOL): Expanded Prostate Cancer Index Composite (EPIC-26)	EPIC-26: Sexual Score	34.67 units on a scale
Arm A (Radiation Therapy)	Quality of Life (QOL): Expanded Prostate Cancer Index Composite (EPIC-26)	EPIC-26: Bowel Score	100 units on a scale
Arm A (Radiation Therapy)	Quality of Life (QOL): Expanded Prostate Cancer Index Composite (EPIC-26)	EPIC-26: Urinary Incontinence Score EPIC-26: Hormonal Score	70 units on a scale
Arm A (Radiation Therapy)	Quality of Life (QOL): Expanded Prostate Cancer Index Composite (EPIC-26)	EPIC-26: Urinary Incontinence Score	46 units on a scale
Arm B (Salvage Oligometastasectomy)	Quality of Life (QOL): Expanded Prostate Cancer Index Composite (EPIC-26)	EPIC-26: Urinary Incontinence Score EPIC-26: Hormonal Score	94.38 units on a scale
Arm B (Salvage Oligometastasectomy)	Quality of Life (QOL): Expanded Prostate Cancer Index Composite (EPIC-26)	EPIC-26: Urinary Incontinence Score	65.22 units on a scale
Arm B (Salvage Oligometastasectomy)	Quality of Life (QOL): Expanded Prostate Cancer Index Composite (EPIC-26)	EPIC-26: Urinary Obstructive/ Irritative Score	86.72 units on a scale
Arm B (Salvage Oligometastasectomy)	Quality of Life (QOL): Expanded Prostate Cancer Index Composite (EPIC-26)	EPIC-26: Bowel Score	94.27 units on a scale
Arm B (Salvage Oligometastasectomy)	Quality of Life (QOL): Expanded Prostate Cancer Index Composite (EPIC-26)	EPIC-26: Sexual Score	42.67 units on a scale

Secondary

Quality of Life (QOL) - The Functional Assessment of Cancer Therapy - Prostate (FACT-P)

FACT-P is a QOL questionnaires administered at the Response Assessment Visit. FACT-P is used to assess the health-related QOL in prostate cancer. Patients indicate which symptoms/problems they've experienced during the past week, from 1 Not at All to 4 Very Much. The assessment was scored according to the FACT-P Scoring Guidelines (Version 4). Individual items that were reverse items (high value indicates poor QOL) were subtracted from 4; reverse and normal items were added to calculate each subscale. The higher the subscale the better the QOL. The subscales and score ranges are: Physical Well-Being (0-28), Social/ Family Well Being (0-28), Emotional Well-Being (0-24), Functional Well Being (0-28), and Prostate Cancer Subscale (0-48) This outcome will report the mean score and 95% confidence interval of each subscale.

Time frame: up to 45 days after the initiation of study therapy

Population: 1 participant did not complete this assessment in Arm A. 10 participants did not complete this assessment in Arm B. No participants were enrolled in Arm C.

Arm	Measure	Group	Value (MEAN)
Arm A (Radiation Therapy)	Quality of Life (QOL) - The Functional Assessment of Cancer Therapy - Prostate (FACT-P)	Social/ Family Well Being	16 units on a scale
Arm A (Radiation Therapy)	Quality of Life (QOL) - The Functional Assessment of Cancer Therapy - Prostate (FACT-P)	Functional Well Being	14 units on a scale
Arm A (Radiation Therapy)	Quality of Life (QOL) - The Functional Assessment of Cancer Therapy - Prostate (FACT-P)	Emotional Well-Being	16 units on a scale
Arm A (Radiation Therapy)	Quality of Life (QOL) - The Functional Assessment of Cancer Therapy - Prostate (FACT-P)	Prostate Cancer Subscale	41 units on a scale
Arm A (Radiation Therapy)	Quality of Life (QOL) - The Functional Assessment of Cancer Therapy - Prostate (FACT-P)	Physical Well-Being	26 units on a scale
Arm B (Salvage Oligometastasectomy)	Quality of Life (QOL) - The Functional Assessment of Cancer Therapy - Prostate (FACT-P)	Prostate Cancer Subscale	36.50 units on a scale
Arm B (Salvage Oligometastasectomy)	Quality of Life (QOL) - The Functional Assessment of Cancer Therapy - Prostate (FACT-P)	Physical Well-Being	25.75 units on a scale
Arm B (Salvage Oligometastasectomy)	Quality of Life (QOL) - The Functional Assessment of Cancer Therapy - Prostate (FACT-P)	Social/ Family Well Being	24.13 units on a scale
Arm B (Salvage Oligometastasectomy)	Quality of Life (QOL) - The Functional Assessment of Cancer Therapy - Prostate (FACT-P)	Emotional Well-Being	19.88 units on a scale
Arm B (Salvage Oligometastasectomy)	Quality of Life (QOL) - The Functional Assessment of Cancer Therapy - Prostate (FACT-P)	Functional Well Being	24.50 units on a scale

Secondary

To Assess Time to Disease Recurrence Following Treatment of Oligometastatic Disease.

The time from study enrollment until the date of confirmed radiographic disease progression as defined by RECIST 1.1 and PCWG3.

Time frame: Time elapsed between study enrollment and confirmed radiographic disease progression, up to 3 years

Secondary

To Assess Time to Initiation of ADT for Metastatic Prostate Cancer Following Treatment of Oligometastatic Disease.

The time from study enrollment to the initiation of ADT

Time frame: Up to 3 years

Secondary

Undetectable PSA

This outcome measure will report the count of participants with undetectable PSA after 6 and 12 months following completion of treatment (salvage ± adjuvant). Undetectable PSA is defined as the number of patients ever treated with prostatectomy whose PSA remains ≤ 0.2 ng/mL.

Time frame: 6 and 12 months after completion of 5-21 weeks of treatment

Population: No participants were enrolled in Arm C

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Arm A (Radiation Therapy)	Undetectable PSA	PSA ≤ 0.2 at 6 months	Yes	0 Participants
Arm A (Radiation Therapy)	Undetectable PSA	PSA ≤ 0.2 at 6 months	No	2 Participants
Arm A (Radiation Therapy)	Undetectable PSA	PSA ≤ 0.2 at 12 months	Yes	1 Participants
Arm A (Radiation Therapy)	Undetectable PSA	PSA ≤ 0.2 at 12 months	No	1 Participants
Arm B (Salvage Oligometastasectomy)	Undetectable PSA	PSA ≤ 0.2 at 12 months	No	14 Participants
Arm B (Salvage Oligometastasectomy)	Undetectable PSA	PSA ≤ 0.2 at 6 months	Yes	7 Participants
Arm B (Salvage Oligometastasectomy)	Undetectable PSA	PSA ≤ 0.2 at 12 months	Yes	4 Participants
Arm B (Salvage Oligometastasectomy)	Undetectable PSA	PSA ≤ 0.2 at 6 months	No	11 Participants
Arm C (Salvage Oligometastasectomy, Radiation Therapy)	Undetectable PSA	PSA ≤ 0.2 at 12 months	No	0 Participants
Arm C (Salvage Oligometastasectomy, Radiation Therapy)	Undetectable PSA	PSA ≤ 0.2 at 6 months	No	0 Participants
Arm C (Salvage Oligometastasectomy, Radiation Therapy)	Undetectable PSA	PSA ≤ 0.2 at 12 months	Yes	0 Participants
Arm C (Salvage Oligometastasectomy, Radiation Therapy)	Undetectable PSA	PSA ≤ 0.2 at 6 months	Yes	0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Contacts

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Prostate-specific Antigen (PSA) ≥ 50% 6 Months After Completion of All Treatment

Number of Participants With Adverse Events (AE) by Grade

Prostate-specific Antigen (PSA) ≥ 50% 12 Months After Completion of All Treatment

Prostate-specific Antigen (PSA) ≥ 90%

PSA Progression Free-survival

Quality of Life (QOL): Expanded Prostate Cancer Index Composite (EPIC-26)

Quality of Life (QOL) - The Functional Assessment of Cancer Therapy - Prostate (FACT-P)

To Assess Time to Disease Recurrence Following Treatment of Oligometastatic Disease.

To Assess Time to Initiation of ADT for Metastatic Prostate Cancer Following Treatment of Oligometastatic Disease.

Undetectable PSA