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Bladder CancerPhase 2NCT03517995

Randomized, Phase II Clinical Trial of Sulforaphane in Bladder Cancer Chemoprevention

A Phase 2 study testing Sulforaphane Administration in people with Bladder Cancer and Bladder Tumor, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The main purpose of this study is to see if Prostaphane is effective and can help reduce the progression of bladder cancer. Researchers also want to find out if Prostaphane is safe and tolerable, and to evaluate how Prostaphane works to reduce the progression of bladder cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sulforaphane Administration
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
2 sitesUnited States
Study dates
Apr 2020to Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women; age ≥18 years; evidence of non-muscle invasive or muscle invasive primary bladder tumor (urothelial carcinoma +/- variant histology) discovered on cystoscopy or radiologic imaging performed within 60 days of randomization; with no evidence of distant metastases; planned Transurethral Resection+B21 (TURBT), cystoscopy with biopsies or cystectomy (total or partial);
  • Absent prior pelvic radiation; normal organ function;
  • Absent neoadjuvant chemotherapy (refusal or ineligibility); (the participant may have prior intravesical treatment exposure (including Bacillus Calmette-Guerin (BCG), mitomycin, gemcitabine, valrubicin, docetaxel, etc.) for bladder cancer (BC) (excluding primary bladder radiation therapy) provided that treatment was completed greater than 30 days prior to the patient's randomization visit);
  • Non-smokers (urinary cotinine tested);
  • Agree to restrict dietary sources of Sulforaphane (SFN) to 3 or 5 servings/week and abstain from consuming SFN supplements beginning three days prior to start of study and throughout duration of the study;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
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  • Willing to discontinue current vitamin/mineral supplement use and substitute with a standard multivitamin supplement provided for the study;
  • Willing to use an effective method of contraception, if the partner is of child-bearing age, while on study;
  • Willing to comply with proposed visit and treatment schedule;
  • Able to understand and willing to sign a written informed consent document;
  • Participants must have normal organ and marrow function.

Who cannot join

  • Evidence of other cancers (excluding non-melanoma skin cancer) or metastatic disease;
  • Prior pelvic radiation; concurrent systemic chemotherapy for any other cancer, excluding non-melanoma skin cancer;
  • Any treatment for the bladder tumor other than intravesical therapy;
  • Prior treatment with a known histone deacetylase inhibitor (including but not limited to valproic acid, suberoylanilide hydroxamic acid (SAHA), Panobinostat (LBH589), etc.) within 6 months prior to starting study treatment or while on study therapy;
  • Current treatment with warfarin;
  • Use of dietary supplements or herbal remedies which may affect the study outcome - unless the participant is willing to discontinue taking them for 1 month prior to starting study;
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  • Usual consumption of > 5 servings per week of brassica vegetables;
  • Gastrointestinal ailments which would interfere with the ability to adequately absorb SFN;
  • Allergy/known intolerance to cruciferous vegetables;
  • Used antibiotics (more than 3 doses) within 10 days prior to study (day -14 prior to study randomization);
  • Current smoker.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • James A. Haley Veteran's Administration Hospital

    Tampa, Florida, 33612

Other trials in United States

About this study

The main purpose of this study is to see if Prostaphane is effective and can help reduce the progression of bladder cancer. Researchers also want to find out if Prostaphane is safe and tolerable, and to evaluate how Prostaphane works to reduce the progression of bladder cancer. This study will compare Prostaphane with a placebo to see if taking Prostaphane is better than taking a placebo. A placebo is a pill that looks like Prostaphane but has no drug or other active ingredients in it.

The study will be presented to eligible patients by the patient's surgeon at the time when an appointment is made for cystoscopy for suspicion of bladder cancer (BC) or to confirm BC diagnosis.

Read the detailed description

The study will be presented to eligible patients by the patient's surgeon at the time when an appointment is made for cystoscopy for suspicion of bladder cancer (BC) or to confirm BC diagnosis.

Participants will be asked to spend 21 to 30 days in this study. The study will be conducted during the time from when the participant is diagnosed with bladder cancer to when they undergo a surgical procedure for the treatment or removal of their bladder cancer. The surgical procedure is done as a part of their regular medical care. Participants will be asked to come for 1 additional visit as part of this research study at the midpoint between their biopsy and surgery.

Being tested
Sulforaphane Administration, Placebo Administration, Standard of Care Surgery
Keywords
primary bladder tumor, non-muscle invasive bladder tumor, muscle invasive bladder tumor, sulforaphane, chemoprevention
Medical subject headings
Urinary Bladder Neoplasms, Carcinoma, Transitional Cell

What participants receive

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

  • Sulforaphane AdministrationDrug

    Also called Prostaphane

    1 capsule (10 mg Prostaphane) taken two times per day (2 capsules, 20 mg Prostaphane total).

  • Placebo AdministrationOther

    1 capsule (placebo) taken two times per day (2 capsules total).

  • Standard of Care SurgeryProcedure or surgery

    Also called post study treatment surgery, bladder cancer surgery

    The study will be conducted during the time from when participants are diagnosed with bladder cancer to when they undergo a surgical procedure for the treatment or removal of their bladder cancer. The surgical procedure is done as a part of their regular medical care.

Study groups in NCT03517995
Study groupRoleWhat they receive
Sulforaphane Plus SurgeryActive comparatorSulforaphane Administration prior to bladder cancer surgery.
Receives: Drug: Sulforaphane Administration; Procedure: Standard of Care Surgery
Placebo Plus SurgeryPlacebo comparatorPlacebo Administration prior to bladder cancer surgery.
Receives: Other: Placebo Administration; Procedure: Standard of Care Surgery

What is being measured

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

  1. Magnitude of Change

    Magnitude of change in Intermediate Endpoint Biomarkers (IEBs) of proliferation (Ki-67 expressing cells- an independent marker of poor prognosis in bladder cancer (BC)) from baseline to end of treatment with 20 mgs Prostaphane® [Nutinov Labs, France] containing 200 μmol of Sulforaphane (SFN) a day at 3-4 weeks (maximum 30 days) in BC cells and benign/adjacent cells.

    Measured: Up to 30 days

Secondary outcomes (6)

  1. Effectiveness of Sulforaphane vs. Placebo

    Effectiveness of SFN at this dose (vs. placebo) as indicated by modulation of other IEBs of proliferation, apoptosis and phase II enzymes, as well as the potential molecular mechanism of SFN, we will measure changes in: (i) BC histology grade; (ii) labeling index of a sensitive biomarker that is a member of DNA replication origin licensing complex, Mcm2; (iii) apoptosis (Caspase-3); (iv) Phase II enzymes (glutathione transferases, epoxide hydrolase, Nicotinamide adenine dinucleotide phosphate (NAD(P)H): quinone reductase, and glucuronosyltransferases); (v) Nrf2 and Transcription factor (NF-kB) signaling, from baseline to end of treatment in BC cells and benign/adjacent cells.

    Measured: End of study, approximately 30 days

  2. Occurrence of Adverse Events per Study Arm

    Safety of SFN at this dose (vs. Placebo) as indicated by incidence of adverse events and toxicities, monitored using Common Toxicity Criteria version 5.0, complete blood count (CBC), and complete metabolic panel (CMP) from baseline at mid-point and at end of trial.

    Measured: End of study, approximately 30 days

  3. Mid-study Bioavailability of Sulforaphane

    Bioavailability, of SFN at this dose vs. Placebo. Investigators will measure change in SFN in plasma and bladder tissue from baseline, at mid-point and at end of study.

    Measured: Mid-study, approximately 15 days

  4. End of Study Bioavailability of Sulforaphane

    Bioavailability, of SFN at this dose vs. Placebo. Investigators will measure change in SFN in plasma and bladder tissue from baseline, at mid-point and at end of study.

    Measured: End of study, approximately 30 days

  5. Adherence of Sulforaphane vs. Placebo

    Adherence based on pill counts and diet and pill logs from baseline.

    Measured: End of study, approximately 30 days

  6. Acceptability of Sulforaphane vs. Placebo

    Acceptability based on pill counts and diet and pill logs from baseline.

    Measured: End of study, approximately 30 days

Timeline

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

  1. First posted8 May 2018
  2. Study startApr 2020 (estimated)
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2022 (estimated)

Why it stopped: Grant not approved

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03517995
Sponsor's protocol ID
MCC-19574
Status last verified
Feb 2020
First submitted
26 Apr 2018
Last updated
28 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sulforaphane Administration in people with Bladder Cancer and Bladder Tumor, run by H. Lee Moffitt Cancer Center and Research Institute at 2 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 11 inclusion and 11 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: withdrawn, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Magnitude of Change (time frame: Up to 30 days). 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 NCT03517995.

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 May 2020.

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