Adenocarcinoma of the ProstatePhase 3NCT03535675

Muscadine Plus (MPX) In Men With Prostate Cancer

A Phase 3 study testing Muscadine Plus in people with Adenocarcinoma of the Prostate, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 13 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This research is being done to determine if men with rising PSA after initial therapy for localized prostate cancer who display the Alanine/Alanine SOD2 genotype of MnSOD and supplement their diet with MPX have greater decrease in PSA slope following treatment compared to men that do not supplement with MPX. Read more about this study

Who is it for?: Ages 18 to 99 years, men only
Conditions the study is for: Adenocarcinoma of the Prostate
What is being tested?: Muscadine Plus
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 59 participants
Where: 13 sitesUnited States
Study dates: 30 Oct 2018to 3 Nov 2022
Phase: Phase 3
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 99 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients meeting the following conditions are eligible for registration and participation in the study:
Subject has histologically or cytologically confirmed adenocarcinoma of the prostate
Subject has undergone definitive treatment (surgery, surgery with radiation therapy, cryotherapy, radiation therapy or brachytherapy) for the primary prostate tumor (prior chemotherapy is not allowed) .
A subject with a rising PSA post-prostatectomy should consider radiation as a potentially curative alternative. If subject declines radiation or is not a candidate for radiation, he may be considered eligible in this setting.
Subject has a rising PSA on a minimum of 3 time points (2 rises) within the 12 months prior to study initiation (this will include the PSA measurement taken at the screening visit, but not at the baseline day 0 study visit).
For purposes of calculating PSA doubling time (PSADT):

Show all 31Show fewer

All PSA values used in the calculation should be ≥ 0.20 ng/ml and overall should follow a rising trend;
Record every available PSA drawn within the last 12 months of the most recent local PSA;
The minimum requirement is 3 PSA values obtained over 3 months with a minimum of 4 weeks between measurements;
If there are 4 or more PSAs available, the time interval between the first and last PSA measurements must be at least 3 months, and, there is no minimum time interval requirement between any two PSA measurements;
For radiotherapy only patients, record PSA nadir value and collection date. PSADT (PSA doubling time) must be positive according to Memorial Sloan Kettering Cancer Center Prostate Cancer Nomograms under this link: http://www.mskcc.org/applications/nomograms/prostate/PsaDoublingTime.aspx
One of the following criteria must be met.
Absolute level of PSA >0.4 ng/mL following surgery. (surgery only)
Absolute level of PSA >0.4 ng/mL for subjects treated with multiple treatment modalities (e.g., surgery + radiation, surgery + cryotherapy, etc.).
A rise by 2 ng/mL or more above the nadir PSA will be considered the standard definition for biochemical failure after radiation therapy with or without hormonal therapy. (radiation only)
Subject is >18 years of age.
Subject has life expectancy of greater than 12 months.
Subject has Eastern Cooperative Oncology Group performance status 0, 1 or 2
Subject has testosterone level of ≥1.5 ng/mL at screening.
Subject has normal organ and marrow function as defined below:
Leukocytes >3,000/microliter
absolute neutrophil count >1,500/microliter
platelets >100,000/microliter
total bilirubin <1.5 x upper limit of normal except for Gilberts <2.5 x upper limit of normal
aspartate aminotransferase/Alanine transaminase ≤ 2.5 X upper limit of normal
creatinine ≤ 2.5 upper limit of normal
Subject agrees to abstain from other commercially available MuscadinePlus (MP) products (Vinetra, MuscadinePlus or MP capsules) while participating in this study.
Subject's use of other dietary/herbal supplements (e.g. saw palmetto, selenium, pomegranate juice or pills, acai concentrated extract, etc) has been stable for at least 2 months prior to screening and the subject agrees not to stop or change the dose(s) while participating in the study.
Subject has signed a written informed consent document and agrees to comply with requirements of the study.
CT or MRI chest/abdomen/pelvis and bone scan without evidence of metastatic disease as an inclusion.
Subject agrees to genotyping of manganese-dependent superoxide dismutase 2 (MnSOD2) gene and any genetic counseling. Only those with Alanine/Alanine SOD2 genotype will be randomized.

Who cannot join

Subjects meeting the following conditions are not eligible for participation in the study:
Subject has known radiographic evidence of metastatic disease, except for presence of positive lymph nodes from the surgical pathology. Pelvic/intraperitoneal lymph nodes less than 1.5 cm maybe considered nonspecific and the patient would be eligible. If there is any clinical suspicion for metastatic disease, CT and Bone Scan must be performed to rule out metastatic disease, within the last four months, per standard of care.
Subject has received any therapies that modulate testosterone levels (e.g., androgen ablative/anti-androgen therapy, 5 alpha reductase inhibitors) for a minimum of 12 months prior to study.
Subject has had prior or concomitant treatment with experimental drugs, high dose steroids, or any other cancer treatment within 4 weeks prior to the first dose of the study product.
Subject has consumed any Muscadine Plus over the past 2 months.
Subject has a known allergy to muscadine grapes, ellagic acid or rice
Subject has uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Subject has negative PSA doubling time (negative doubling time corresponds with decreasing PSA) Doubling time may be computed using the Sloan Kettering prediction tools posted at http://www.mskcc.org/applications/nomograms/prostate/PsaDoublingTime.aspx

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado Cancer Center
Aurora, Colorado, 80045
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of Virginia
Charlottesville, Virginia, 22908
University of Chicago
Chicago, Illinois, 60637
Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope
Duarte, California, 91010
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016

Other trials in United States

About this study

Official title: A Randomized Double-Blind, Placebo-Controlled Study Of The Effects Of MPX Capsules On Rising Prostate-Specific Antigen Levels In Alanine/Alanine SOD2 Genotype Men Following Initial Therapy For Prostate Cancer

Read the detailed description

Prostate specific antigen (PSA) is a single-chain glycoprotein produced by the epithelial cells of the prostate. PSA has been used for early detection and monitoring of patients with prostate cancer who receive a variety of treatments. Due to the widespread use of serum PSA to monitor for prostate cancer recurrence following primary treatment, there exists a group of men with a rising PSA as their only evidence of recurrence. These patients may not demonstrate clinical or radiographic evidence of disease progression for an average 8 years from the time of detectable PSA to detectable metastatic disease by standard imaging. Currently there are limited treatment options for these patients that may delay disease progression or improve survival, including salvage radiation for prior surgical patients, hormonal therapy, and active surveillance.

Although some surgical patients are candidates for salvage radiation, not all patients will want salvage radiation. Even the early initiation of hormonal therapy (e.g., luteinizing hormone releasing hormone (LHRH) analogs) has not demonstrated a survival benefit, although Schroder et al suggests an advantage for early hormone therapy in the setting of metastatic regional lymph nodes. Furthermore, early initiation of androgen ablation is associated with significant morbidity and impact on quality of life, including fatigue, hot flashes, loss of libido, decreased muscle mass, and osteoporosis with long term use. This group of relatively well men with biochemical recurrence are currently offered androgen ablation therapy or active surveillance (regular PSA monitoring and annual scans) until there is evidence of metastatic disease, because other options have not been available. These patients are excellent candidates for innovative treatments hypothesized to slow the progression of clinical prostate cancer and delay the development of metastatic disease.

As the previous section documents, preclinical studies of muscadine grape skin offer evidence that it may extend the time between biochemical recurrence and development of metastatic disease. While the Phase II study described above found no significant difference in PSA doubling time between placebo and either dose of MPX, there was a signal of benefit in the subgroup analysis of men with the Alanine/Alanine superoxide dismutase 2 (SOD2) genotype that received high dose MPX. It is therefore proposed to test the benefits of high dose MPX in capsule formulation in a randomized, controlled study of men who have failed primary therapy, either radiation, surgery or cryotherapy, as primary treatment for prostate cancer. Eligible subjects will have a rising PSA and will have 3 PSA values at least 7 days apart with a recovered testosterone to be able to calculate a baseline PSA doubling time. The primary endpoint of this study will be mean PSA slope during the study period.

Conditions: Adenocarcinoma of the Prostate
Being tested: Muscadine Plus, Placebos

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Muscadine PlusDrug
Also called MPX
Ellagic acid inhibits DNA Methyltransferase. DNA Methyltransferases (DNMTs) are a family of enzymes that regulate chromatin methylation and use S-adenosyl methionine (SAM) as the methyl donor. Ellagic acid's metabolite, urolithin-A inhibits the protein complex nuclear factor kappa-light-enhancer of activated B-cells (NFkB), potentially leading to increased rates of apoptosis and decreases in cancer cell proliferation. Extracts from Vitis rotundifolia have shown inhibition of the phosphatidylinositol 3-kinase-Akt pathway.
PlacebosDrug
Also called Placebo
The placebo capsules are rice flour that will be placed in white opaque capsules identical to the ones used for MPX.

Study groups in NCT03535675
Study group	Role	What they receive
Muscadine Plus	Experimental	Each treatment cycle consists of once daily oral dosing of 4000 mg Muscadine Plus, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of study drug and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug. Receives: Drug: Muscadine Plus
Placebo	Experimental	Each treatment cycle consists of once daily oral dosing of 4000 mg placebos, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of placebo and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug. Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

Prostate Specific Antigen (PSA) Response
To determine if men who display the Alanine/Alanine superoxide dismutase 2 (SOD2) genotype of MnSOD and supplement their diet with MPX have greater changes in PSA slope following treatment compared to men that do not supplement with MPX.
PSA response will be measured as the change of serum PSA in ng/mL/month, on-study PSA slope for each patient with comparisons between treatment arms adjusted for pre-study PSA slope; on-study PSA slope was calculated from PSA values taken at baseline,12, 24, 36, and 48 weeks, and calculated as the slope of the simple linear regression of the natural log of PSA versus time in ng/mL/month.
Measured: baseline,12, 24, 36, and 48 weeks

Secondary outcomes (4)

PSA Doubling Time
PSA doubling time (PSADT) will be calculated in months by measuring the PSA values within 12 months from start of intervention.
Measured: Up to 26 months
PSA Objective Response Rate
The number of patients with a decrease in PSA of ≥50%
Measured: Up to 1 year
PSA Progression
The time to disease progression for both treatment groups by PSA progression. PSA progression is defined as an increase in PSA greater than 50% and >5 ng/ml above nadir.
Measured: 2 years
Radiographic Progression
The time to disease progression for both treatment groups by radiologic disease progression (i.e. development of metastatic disease).
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 20183 Nov 2022

First posted24 May 2018
Study start30 Oct 2018
Primary completion6 Jul 2022
Study completion3 Nov 2022

Why it stopped: The study was terminated by DSMB due to futility.

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 (1)Papers the sponsor has linked to this study.
Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a multicenter, double-blind, randomized study to evaluate the benefit of MPX supplementation in the subset of men who display the Alanine/Alanine SOD2 genotype of MnSOD. Based on a previous randomized phase II trial of MPX at Hopkins, PSA doubling time (PSA-DT) was prolonged in this subgroup of men.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03535675
Sponsor's protocol ID: J1823
Other IDs: IRB00166021
Status last verified: Apr 2023
First submitted: 10 May 2018
Last updated: 22 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Mandl A, Zahurak ML, Metri NA, Shore ND, Mao S, McKay RR, Taplin ME, Szmulewitz RZ, Maughan BL, Reichert ZR, Kessler ER, Heath EI, Dreicer R, Stein CA, Milne GL, Sfanos KS, Ernst SE, Mummert LA, Cruz-Lebron A, Michel SLJ, Kane MA, Hursey M, Worth MA, Wagner WD, Eshleman JR, Debeljak M, Xu L, Cao H, Dowling D, Marshall CH, Markowski MC, Denmeade SR, Eisenberger MA, Antonarakis ES, Carducci MA, Paller CJ. Muscadine Grape Skin Extract in Biochemically Recurrent Prostate Cancer: A Randomized, Placebo-Controlled, Biomarker-Enriched Trial in Patients With the SOD2 Ala/Ala Variant. Prostate. 2025 Jul;85(10):966-976. doi: 10.1002/pros.24903. Epub 2025 May 5.
PubMed 40325900

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Adenocarcinoma of the Prostate trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Double-Blind, Placebo-Controlled Study Of The Effects Of MPX Capsules On Rising Prostate-Specific Antigen Levels In Alanine/Alanine SOD2 Genotype Men Following Initial Therapy For Prostate Cancer
ClinicalTrials.gov ID: NCT03535675
Acronym / sponsor ID: J1823
Conditions: Adenocarcinoma of the Prostate
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated by DSMB due to futility.
Enrolment: 59 participants (actual)
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
Collaborators: Greater Washington Community Foundation
Study start: 30 Oct 2018 (actual)
Primary completion: 6 Jul 2022 (actual)
Study completion: 3 Nov 2022 (actual)
First posted: 24 May 2018 (actual)
Results: Posted 22 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: This is a multicenter, double-blind, randomized study to evaluate the benefit of MPX supplementation in the subset of men who display the Alanine/Alanine SOD2 genotype of MnSOD. Based on a previous randomized phase II trial of MPX at Hopkins, PSA doubling time (PSA-DT) was prolonged in this subgroup of men.

Arm	Type	Receives
Muscadine Plus	Experimental	Drug: Muscadine PlusEach treatment cycle consists of once daily oral dosing of 4000 mg Muscadine Plus, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of study drug and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.
Placebo	Experimental	Drug: PlacebosEach treatment cycle consists of once daily oral dosing of 4000 mg placebos, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of placebo and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.

Who may qualify

Ages: 18 to 99 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (31 listed)

Patients meeting the following conditions are eligible for registration and participation in the study:
Subject has histologically or cytologically confirmed adenocarcinoma of the prostate
Subject has undergone definitive treatment (surgery, surgery with radiation therapy, cryotherapy, radiation therapy or brachytherapy) for the primary prostate tumor (prior chemotherapy is not allowed) .
Subject has a rising PSA on a minimum of 3 time points (2 rises) within the 12 months prior to study initiation (this will include the PSA measurement taken at the screening visit, but not at the baseline day 0 study visit).
One of the following criteria must be met.

Key exclusion criteria (8 listed)

Subjects meeting the following conditions are not eligible for participation in the study:
Subject has known radiographic evidence of metastatic disease, except for presence of positive lymph nodes from the surgical pathology. Pelvic/intraperitoneal lymph nodes less than 1.5 cm maybe considered nonspecific and the patient would be eligible. If there is any clinical suspicion for metastatic disease, CT and Bone Scan must be performed to rule out metastatic disease, within the last four months, per standard of care.
Subject has received any therapies that modulate testosterone levels (e.g., androgen ablative/anti-androgen therapy, 5 alpha reductase inhibitors) for a minimum of 12 months prior to study.
Subject has had prior or concomitant treatment with experimental drugs, high dose steroids, or any other cancer treatment within 4 weeks prior to the first dose of the study product.
Subject has consumed any Muscadine Plus over the past 2 months.

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
Muscadine PlusAlso: MPXEllagic acid inhibits DNA Methyltransferase. DNA Methyltransferases (DNMTs) are a family of enzymes that regulate chromatin methylation and use S-adenosyl methionine (SAM) as the methyl donor. Ellagic acid's metabolite, urolithin-A inhibits the protein complex nuclear factor kappa-light-enhancer of activated B-cells (NFkB), potentially leading to increased rates of apoptosis and decreases in cancer cell proliferation. Extracts from Vitis rotundifolia have shown inhibition of the phosphatidylinositol 3-kinase-Akt pathway.	Drug	Muscadine Plus
PlacebosAlso: PlaceboThe placebo capsules are rice flour that will be placed in white opaque capsules identical to the ones used for MPX.	Drug	Placebo

Primary outcome

Prostate Specific Antigen (PSA) Response
Time frame: baseline,12, 24, 36, and 48 weeks
To determine if men who display the Alanine/Alanine superoxide dismutase 2 (SOD2) genotype of MnSOD and supplement their diet with MPX have greater changes in PSA slope following treatment compared to men that do not supplement with MPX. PSA response will be measured as the change of serum PSA in ng/mL/month, on-study PSA slope for each patient with comparisons between treatment arms adjusted for pre-study PSA slope; on-study PSA slope was calculated from PSA values taken at baseline,12, 24, 36, and 48 weeks, and calculated as the slope of the simple linear regression of the natural log of PSA versus time in ng/mL/month.

4 secondary outcomes

PSA Doubling Time
Time frame: Up to 26 months
PSA Objective Response Rate
Time frame: Up to 1 year
PSA Progression
Time frame: 2 years
Radiographic Progression
Time frame: 2 years

Results and safety

Results posted to the registry on 22 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Muscadine Plus	29	29
Placebo	30	30

Primary outcome: Prostate Specific Antigen (PSA) Response

Time frame: baseline,12, 24, 36, and 48 weeks. Mean (95% Confidence Interval). Unit: ng/mL/Month

Measure	Muscadine Plus n = 29	Placebo n = 30
Value	0.106 (0.08 to 0.13)	0.089 (0.06 to 0.11)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 2 years. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Muscadine Plus	1 of 29 (3.4%)	22 of 29 (75.9%)	0 of 29
Placebo	6 of 30 (20%)	23 of 30 (76.7%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40325900Mandl A, Zahurak ML, Metri NA, Shore ND, Mao S, McKay RR, Taplin ME, Szmulewitz RZ, Maughan BL, Reichert ZR, Kessler ER, Heath EI, Dreicer R, Stein CA, Milne GL, Sfanos KS, Ernst SE, Mummert LA, Cruz-Lebron A, Michel SLJ, Kane MA, Hursey M, Worth MA, Wagner WD, Eshleman JR, Debeljak M, Xu L, Cao H, Dowling D, Marshall CH, Markowski MC, Denmeade SR, Eisenberger MA, Antonarakis ES, Carducci MA, Paller CJ. Muscadine Grape Skin Extract in Biochemically Recurrent Prostate Cancer: A Randomized, Placebo-Controlled, Biomarker-Enriched Trial in Patients With the SOD2 Ala/Ala Variant. Prostate. 2025 Jul;85(10):966-976. doi: 10.1002/pros.24903. Epub 2025 May 5.
Individual participant dataSharing planned: No

Related trials for Adenocarcinoma of the Prostate

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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.

Channing Paller, M.D principal investigator

SKCCC at Johns Hopkins

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Muscadine Plus in people with Adenocarcinoma of the Prostate, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 13 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 31 inclusion and 8 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: stopped early, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 22 May 2023). 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?

Prostate Specific Antigen (PSA) Response (time frame: baseline,12, 24, 36, and 48 weeks). 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 NCT03535675, which also lists 1 linked publication.

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 22 May 2023.