Adenocarcinoma of the ProstatePhase 2NCT02203695
Randomized Salvage Radiation Therapy Plus Enzalutamide Post Prostatectomy
A Phase 2 study testing Enzalutamide and SRT in people with Adenocarcinoma of the Prostate, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 9 sites in United States.
Trial summary
The primary hypothesis of this study is that outcomes for patients with biochemically recurrent prostate cancer following radical prostatectomy will be improved by the addition of enzalutamide for 6-months compared to standard-of-care salvage radiation therapy to allow for further study in the definitive phase III… Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate
- What is being tested?
- Enzalutamide and SRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 9 sitesUnited States
- Study dates
- 28 Mar 2015to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPPA) authorization for the release of personal health information.
- Males aged 18 years of age and above
- Patients must have adenocarcinoma of the prostate gland
- Patients must have received primary treatment with radical prostatectomy.
- Patients must have evidence of biochemical (PSA) relapse after prostatectomy
- Patients must have PSA within study range
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- Patients must have non-metastatic (M0) disease, as defined by a lack of metastases seen on CT scan of the chest/abdomen/pelvis and whole-body radionuclide 99Technetium (Tc) bone scan, (or sodium fluoride PET scan) taken within 3 months of study entry.
- Patients must have had node negative (pN0) disease found at the time of surgery.
- Patients must have non-castrate levels of serum testosterone levels within study range.
- Patients must not have previously received hormonal therapy (LHRH agonist, antiandrogen, or both), with the exception of neoadjuvant or adjuvant hormones given in conjunction with prostatectomy.
- Patients must have Eastern Cooperative Oncology Group (ECOG)performance status of 0-1, and life expectancy greater 3 years.
- Patients must have laboratory test results within the certain ranges
- Patients must be disease-free from prior malignancies for greater than 3 years, with the exception of non-melanoma skin cancers and superficial urothelial cancers.
- Patients must have the ability to swallow the study drug whole as a tablet or capsule.
- Throughout study, male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration or per local guidelines where these require additional description of contraceptive methods.
- Throughout the study, patients must use a condom if having sex with a pregnant woman.
Who cannot join
- Currently active second malignancy
- Primary treatment with radiation therapy.
- Radiographic or clinical evidence of local-regional tumor recurrence,
- Concurrent use of other antiandrogens, estrogen-like agents, or 5a-reductase inhibitors.
- Use of systemic corticosteroids equivalent to prednisone (inhaled corticosteroids are permitted).
- Concurrent use of other anti-cancer agents or treatments.
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- Serious concurrent medical illnesses (including uncontrolled major cardiac, pulmonary, Child-Pugh C liver or psychiatric diseases) or active major infections (including HIV, Hepatitis A-C).
- Clinically significant cardiovascular disease including:
- Myocardial infarction within 6 months of Screening visit.
- Uncontrolled angina within 3 months of Screening visit.
- Congestive heart failure (within certain ranges)
- History of clinically significant ventricular arrhythmias
- Prolonged corrected QT interval
- History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place.
- Hypotension within certain ranges
- Uncontrolled hypertension within certain ranges
- Medications which lowers seizure threshold.
- History of seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumors, brain metastases, or alcoholism. Also, history of loss of consciousness or transient ischemic attack within 12months of enrollment (Day 1 visit).
- Patients taking medications that may have adverse interactions with enzalutamide
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
Suburban Hospital
Bethesda, Maryland, 20814
University of Chicago Medical Center
Chicago, Illinois, 60637
Karmanos Cancer Center
Detroit, Michigan, 48201
Indiana University
Lafayette, Indiana, 47904
Oregon Health Sciences University
Portland, Oregon, 97239
University of Utah - Huntsman Cancer Center
Salt Lake City, Utah, 84112
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
About this study
Official title: Phase II Randomized Placebo-Controlled Double-Blind Study of Salvage Radiation Therapy (SRT) Plus Placebo Versus SRT Plus Enzalutamide in Men With High-Risk PSA-Recurrent Prostate Cancer After Radical Prostatectomy
The primary hypothesis of this study is that outcomes for patients with biochemically recurrent prostate cancer following radical prostatectomy will be improved by the addition of enzalutamide for 6-months compared to standard-of-care salvage radiation therapy to allow for further study in the definitive phase III setting. This study builds on the prior success of high-dose bicalutamide (for 24 months) when combined with salvage external radiation therapy (XRT), while using a newer more potent anti-androgen for a shorter duration of time (6 months) in an effort to minimize adverse effects.
Read the detailed description
Enzalutamide is a second-generation androgen receptor signaling inhibitor that significantly prolongs survival in patients with metastatic castration-resistant prostate cancer who have received prior docetaxel chemotherapy 35,36. Enzalutamide has demonstrated activity in cells that overexpress the androgen receptor. Unlike previous androgen receptor blocker (ARB) agents, Enzalutamide does not display any agonist properties and blocks translocation of the ligand-receptor complex into the nucleus preventing DNA binding 33. Enzalutamide is an oral agent that is generally well tolerated and does not require concurrent steroid administration, which makes it an ideal candidate for combination with salvage radiation therapy (SRT).
Finally, provocative preliminary Phase II data presented at the American Society of Clinical Oncology (ASCO) 2013 by M. Smith and colleagues assessed the efficacy and safety of 25-weeks (~6-mos) of enzalutamide alone in prostate cancer of all stages who had never received hormone therapy; presenting with non-castrate testosterone levels ( 230 ng/dL). Enzalutamide alone for 6-mos achieved a high PSA response rate with efficacy similar to castration, but .in contrast to castration, bone mineral density (BMD) remained stable and metabolic variables were not substantially impacted.
The trial described here differs from Radiation Therapy Oncology Group (RTOG) 96-01, RTOG 05-34 and RADICALS in several ways. First, the eligibility criteria are stricter; less favorable patients have been selected. Second, short-term ARB is being tested, while in RTOG 96-01 and RADICALS long-term ARB of 2-years was examined. Finally, and most importantly, we are testing the second generation ARB agent, enzalutamide, alone in combination with SRT as opposed to RTOG 05-34 and RADICALS which use androgen deprivation (AD).
This trial is not intended to address the efficacy of SRT alone over observation. The complete response rate (a drop in PSA to undetectable levels) after SRT is 70%-80% and durable responses are observed in 30%-40% of patients. For these reasons, it is not feasible or appropriate to randomize men between observation and SRT. The more important issue is whether the proportion of durable responses is increased by altering the therapeutic approach, such as the use of enhanced ARB using enzalutamide.
- Conditions
- Adenocarcinoma of the Prostate
- Being tested
- Enzalutamide, SRT
- Keywords
- Salvage Radiation Therapy (SRT), Enzalutamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnzalutamideDrug
Also called XTANDI
Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
SRTRadiation
Also called Salvage Radiation Therapy
Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx
| Study group | Role | What they receive |
|---|---|---|
| SRT plus Enzalutamide | Experimental | Arm 2 (experimental): (SRT) Salvage radiation therapy (Three dimensional conformal radiation therapy (3D-CRT)/IMRT [Intensity-modulated radiation therapy]) 66.6-70.2 Gy as 1.8 Gy M-F for 37-39 fx PLUS Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT) Receives: Drug: Enzalutamide |
| SRT plus placebo | Placebo comparator | Arm 1 (control): Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT (Intensity-modulated radiation therapy)) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx PLUS Placebo PO daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT) Receives: Radiation: SRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants With Freedom of PSA (Prostate Specific Antigen) Progression
The primary efficacy endpoint is the rate of Freedom-from-PSA-progression (FFPP) at 2-years. FFPP is defined as the time from randomization to the date of PSA progression. A subject who does not have PSA progression at the time of the analysis will be censored at the last date of PSA measurement.
Measured: From time of randomization to date of PSA progression, approximately 2 years.
Secondary outcomes (7)
Number of Participants With Local Recurrence
Local recurrence within the radiation field (confirmed pathologically) at 2-years
Measured: 2 years from end of radiation therapy
Metastatic Free Survival Rate
Metastasis-free survival (MFS) rates at 2 years. Metastasis-free survival will be defined as the time from the date of registration to date of evidence of systemic disease on bone scan or cross sectional imaging or death, which occurs first. Number of participants with a metastasis event at 2 years is reported.
Measured: 2 years from the time of registration
How Well Participants Tolerate Treatment Assessed by European Organization for Research & Treatment of Cancer Quality of Life (Questionnaire (EORTC-QLQ-P25)
The European Organization for the Research and Treatment of Cancer (EORTC-QLQ-P25) quality of life questionnaire, Prostate Cancer Module. Uses a 4-point Likert scale, with responses ranging from "not at all" to "very much" for sexual symptoms and treatment related symptoms. Domain scores range 0 to 100, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).
Measured: Baseline, End of Treatment (180 Days) and 6 Months Post-treatment
How Well Participants Tolerate Treatment Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P).
The Functional Assessment of Cancer Therapy (FACT-P), assesses the health-related quality of life in men with prostate cancer. The score is the sum of all 5 domain scores and ranges from 0 to156 where higher scores represent better quality of life.
Measured: Baseline, End of Treatment (180 Days) and 6 Months Post-treatment
How Well Participants Tolerate Treatment Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire score range is from 0 to 100. A higher score indicates a better level of functioning or quality of life.
Measured: Baseline, End of Treatment (180 Days) and 6 Months Post-treatment
How Well Participants Tolerate Treatment Assessed by Sexual Health Inventory in Men (SHIM) Questionnaire.
Quality of life (QoL) tool used to determine participant tolerability of treatment assessed by Sexual Health inventory in Men (SHIM). The questionnaire includes 5-items, and provides a total score from 1 to 25, with higher scores indicating better erectile function and lower scores indicating more severe erectile dysfunction.
Measured: Baseline, End of Treatment (180 Days) and 6 Months Post-treatment
Feasibility of Achieving Stated Accrual
Anticipated accrual of participants versus actual reported enrollment. The goal is 48 in each arm.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study start28 Mar 2015
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc, Medivation, Inc.
- Responsible party
- Sponsor
- Investigators
- Daniel Song, M.D., Principal investigator, The SKCCC at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203695
- Sponsor's protocol ID
- J1454
- Other IDs
- IRB00030471
- Status last verified
- Oct 2025
- First submitted
- 16 Jun 2014
- Last updated
- 28 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Tran PT, Lowe K, Tsai HL, Song DY, Hung AY, Hearn JWD, Miller S, Proudfoot JA, Deek MP, Phillips R, Lotan T, Paller CJ, Marshall CH, Markowski M, Dipasquale S, Denmeade S, Carducci M, Eisenberger M, DeWeese TL, Orton M, Deville C, Davicioni E, Liauw SL, Heath EI, Greco S, Desai NB, Spratt DE, Feng F, Wang H, Beer TM, Antonarakis ES. Phase II Randomized Study of Salvage Radiation Therapy Plus Enzalutamide or Placebo for High-Risk Prostate-Specific Antigen Recurrent Prostate Cancer After Radical Prostatectomy: The SALV-ENZA Trial. J Clin Oncol. 2023 Feb 20;41(6):1307-1317. doi: 10.1200/JCO.22.01662. Epub 2022 Nov 11.
PubMed 36367998Kapoor R, Deek MP, McIntyre R, Raman N, Kummerlowe M, Chen I, Gaver M, Wang H, Denmeade S, Lotan T, Paller C, Markowski M, Carducci M, Eisenberger M, Beer TM, Song DY, DeWeese TL, Hearn JW, Greco S, DeVille C, Desai NB, Heath EI, Liauw S, Spratt DE, Hung AY, Antonarakis ES, Tran PT. A phase II randomized placebo-controlled double-blind study of salvage radiation therapy plus placebo versus SRT plus enzalutamide with high-risk PSA-recurrent prostate cancer after radical prostatectomy (SALV-ENZA). BMC Cancer. 2019 Jun 13;19(1):572. doi: 10.1186/s12885-019-5805-z.
PubMed 31196032
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Placebo-Controlled Double-Blind Study of Salvage Radiation Therapy (SRT) Plus Placebo Versus SRT Plus Enzalutamide in Men With High-Risk PSA-Recurrent Prostate Cancer After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT02203695
- Acronym / sponsor ID
- J1454
- Conditions
- Adenocarcinoma of the Prostate
- Keywords
- Salvage Radiation Therapy (SRT), Enzalutamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc, Medivation, Inc.
- Study start
- 28 Mar 2015 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Posted 24 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary hypothesis of this study is that outcomes for patients with biochemically recurrent prostate cancer following radical prostatectomy will be improved by the addition of enzalutamide for 6-months compared to standard-of-care salvage radiation therapy to allow for further study in the definitive phase III setting. This study builds on the prior success of high-dose bicalutamide (for 24 months) when combined with salvage external radiation therapy (XRT), while using a newer more potent anti-androgen for a shorter duration of time (6 months) in an effort to minimize adverse effects.
Detailed description
Enzalutamide is a second-generation androgen receptor signaling inhibitor that significantly prolongs survival in patients with metastatic castration-resistant prostate cancer who have received prior docetaxel chemotherapy 35,36. Enzalutamide has demonstrated activity in cells that overexpress the androgen receptor. Unlike previous androgen receptor blocker (ARB) agents, Enzalutamide does not display any agonist properties and blocks translocation of the ligand-receptor complex into the nucleus preventing DNA binding 33. Enzalutamide is an oral agent that is generally well tolerated and does not require concurrent steroid administration, which makes it an ideal candidate for combination with salvage radiation therapy (SRT).
Finally, provocative preliminary Phase II data presented at the American Society of Clinical Oncology (ASCO) 2013 by M. Smith and colleagues assessed the efficacy and safety of 25-weeks (~6-mos) of enzalutamide alone in prostate cancer of all stages who had never received hormone therapy; presenting with non-castrate testosterone levels ( 230 ng/dL). Enzalutamide alone for 6-mos achieved a high PSA response rate with efficacy similar to castration, but .in contrast to castration, bone mineral density (BMD) remained stable and metabolic variables were not substantially impacted.
The trial described here differs from Radiation Therapy Oncology Group (RTOG) 96-01, RTOG 05-34 and RADICALS in several ways. First, the eligibility criteria are stricter; less favorable patients have been selected. Second, short-term ARB is being tested, while in RTOG 96-01 and RADICALS long-term ARB of 2-years was examined. Finally, and most importantly, we are testing the second generation ARB agent, enzalutamide, alone in combination with SRT as opposed to RTOG 05-34 and RADICALS which use androgen deprivation (AD).
This trial is not intended to address the efficacy of SRT alone over observation. The complete response rate (a drop in PSA to undetectable levels) after SRT is 70%-80% and durable responses are observed in 30%-40% of patients. For these reasons, it is not feasible or appropriate to randomize men between observation and SRT. The more important issue is whether the proportion of durable responses is increased by altering the therapeutic approach, such as the use of enhanced ARB using enzalutamide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SRT plus Enzalutamide | Experimental | Drug: EnzalutamideArm 2 (experimental): (SRT) Salvage radiation therapy (Three dimensional conformal radiation therapy (3D-CRT)/IMRT [Intensity-modulated radiation therapy]) 66.6-70.2 Gy as 1.8 Gy M-F for 37-39 fx PLUS Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT) |
| SRT plus placebo | Placebo comparator | Radiation: SRTArm 1 (control): Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT (Intensity-modulated radiation therapy)) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx PLUS Placebo PO daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPPA) authorization for the release of personal health information.
- Males aged 18 years of age and above
- Patients must have adenocarcinoma of the prostate gland
- Patients must have received primary treatment with radical prostatectomy.
- Patients must have evidence of biochemical (PSA) relapse after prostatectomy
Key exclusion criteria (19 listed)
- Currently active second malignancy
- Primary treatment with radiation therapy.
- Radiographic or clinical evidence of local-regional tumor recurrence,
- Concurrent use of other antiandrogens, estrogen-like agents, or 5a-reductase inhibitors.
- Use of systemic corticosteroids equivalent to prednisone (inhaled corticosteroids are permitted).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnzalutamideAlso: XTANDIEnzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT) | Drug | SRT plus Enzalutamide |
| SRTAlso: Salvage Radiation TherapySalvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx | Radiation | SRT plus placebo |
Primary outcome
Percent of Participants With Freedom of PSA (Prostate Specific Antigen) Progression
Time frame: From time of randomization to date of PSA progression, approximately 2 years.
The primary efficacy endpoint is the rate of Freedom-from-PSA-progression (FFPP) at 2-years. FFPP is defined as the time from randomization to the date of PSA progression. A subject who does not have PSA progression at the time of the analysis will be censored at the last date of PSA measurement.
7 secondary outcomes
Number of Participants With Local Recurrence
Time frame: 2 years from end of radiation therapy
Metastatic Free Survival Rate
Time frame: 2 years from the time of registration
How Well Participants Tolerate Treatment Assessed by European Organization for Research & Treatment of Cancer Quality of Life (Questionnaire (EORTC-QLQ-P25)
Time frame: Baseline, End of Treatment (180 Days) and 6 Months Post-treatment
How Well Participants Tolerate Treatment Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P).
Time frame: Baseline, End of Treatment (180 Days) and 6 Months Post-treatment
How Well Participants Tolerate Treatment Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
Time frame: Baseline, End of Treatment (180 Days) and 6 Months Post-treatment
How Well Participants Tolerate Treatment Assessed by Sexual Health Inventory in Men (SHIM) Questionnaire.
Time frame: Baseline, End of Treatment (180 Days) and 6 Months Post-treatment
Feasibility of Achieving Stated Accrual
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36367998Tran PT, Lowe K, Tsai HL, Song DY, Hung AY, Hearn JWD, Miller S, Proudfoot JA, Deek MP, Phillips R, Lotan T, Paller CJ, Marshall CH, Markowski M, Dipasquale S, Denmeade S, Carducci M, Eisenberger M, DeWeese TL, Orton M, Deville C, Davicioni E, Liauw SL, Heath EI, Greco S, Desai NB, Spratt DE, Feng F, Wang H, Beer TM, Antonarakis ES. Phase II Randomized Study of Salvage Radiation Therapy Plus Enzalutamide or Placebo for High-Risk Prostate-Specific Antigen Recurrent Prostate Cancer After Radical Prostatectomy: The SALV-ENZA Trial. J Clin Oncol. 2023 Feb 20;41(6):1307-1317. doi: 10.1200/JCO.22.01662. Epub 2022 Nov 11.
- Derived from this study: PubMed 31196032Kapoor R, Deek MP, McIntyre R, Raman N, Kummerlowe M, Chen I, Gaver M, Wang H, Denmeade S, Lotan T, Paller C, Markowski M, Carducci M, Eisenberger M, Beer TM, Song DY, DeWeese TL, Hearn JW, Greco S, DeVille C, Desai NB, Heath EI, Liauw S, Spratt DE, Hung AY, Antonarakis ES, Tran PT. A phase II randomized placebo-controlled double-blind study of salvage radiation therapy plus placebo versus SRT plus enzalutamide with high-risk PSA-recurrent prostate cancer after radical prostatectomy (SALV-ENZA). BMC Cancer. 2019 Jun 13;19(1):572. doi: 10.1186/s12885-019-5805-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Song, M.D. principal investigator
The SKCCC at Johns Hopkins
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enzalutamide and SRT in people with Adenocarcinoma of the Prostate, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants With Freedom of PSA (Prostate Specific Antigen) Progression (time frame: From time of randomization to date of PSA progression, approximately 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02203695, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.