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Adenocarcinoma of the ProstatePhase 2NCT01228084

Sulforaphane in Treating Patients With Recurrent Prostate Cancer

A Phase 2 study testing Sulforaphane, Laboratory biomarker analysis and Pharmacological study in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by OHSU Knight Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial studies how well sulforaphane works in treating patients with recurrent prostate cancer. Sulforaphane may prevent or slow the growth of certain cancers. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Sulforaphane, Laboratory biomarker analysis and Pharmacological study
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Nov 2010to May 2013
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histopathologically or cytologically proven adenocarcinoma of the prostate treated with either a prostatectomy or definitive radiation (external beam or brachytherapy
  • Protocol-Specific Prostate Working Group 2 (PCWG2) Criteria: rising PSA after definitive therapy
  • For post surgical patients: the nadir reference value (#1) is the last PSA measured before increases are documented, with subsequent values obtained a minimum of 1 week apart; if the PSA at time point 3 (value #3A) is greater than that at point 2, then eligibility has been met; if the PSA is not greater than point 2 (value #3B), but value #4 is, the patient is eligible assuming that other criteria are met and values 3A or #4 are 1.0 ng/mL or higher
  • For post radiation therapy patients: the nadir reference value (#1) is the last PSA measured before increases are documented, with subsequent values obtained a minimum of 1 week apart; if the PSA at time point 3 (value #3A) is greater than that at point 2, then eligibility has been met; if the PSA is not greater than point 2 (value #3B), but value #4 is, the patient is eligible assuming that other criteria are met and if values 3A or #4 are 2.0 ng/mL or more above the nadir reference value (#1) according to Phoenix/American Society for Therapeutic Radiology and Oncology (ASTRO) criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status <= 2
  • The following laboratory results within 4 weeks prior to starting study treatment:
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  • White blood cells (WBC) >= 3000/mm^3
  • Neutrophil >= 1,500/mm^3
  • Platelet >= 100,000/mm^3
  • Serum creatinine =< upper limit of normal (ULN)
  • Albumin > 3.0 gm/dL
  • Total bilirubin < 1.5 X ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 1.5 X ULN
  • Testosterone level >= 150ng/dL, and no evidence of progression while on prior hormonal therapy, if applicable (i.e. patient must be non-castrate resistant).
  • Prior androgen therapy is allowed as long as the patient did not progress while on therapy.
  • The following imaging scans within 12 weeks prior to starting study treatment: Whole Body Bone Scan: computed tomography (CT) Chest/Abdomen/Pelvis w/ contrast; NOTE: if contrast medium for CT scan is contraindicated for the patient, documentation of this is required and a CT scan with contrast will not be required; subject still must obtain a CT without contrast, though.
  • Willingness to use effective contraception by study participants or their female partners throughout the treatment period and for at least 2 months following treatment
  • Signed informed patient consent and Health Insurance Portability and Accountability Act (HIPAA) within 3 months prior to starting treatment

Who cannot join

  • Significant active medical illness which in the opinion of the investigator would preclude protocol treatment
  • Measurable and/or evaluable recurrent prostate cancer by imaging (CT scan of the chest, abdomen, and pelvis and bone scan performed within 12 weeks prior to starting treatment) or by physical exam
  • Prior investigational therapy within 30 days prior to starting study treatment
  • 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
  • Concurrent systemic treatment for prostate cancer
  • Current treatment with warfarin
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  • Gastrointestinal ailments which would interfere with the ability to adequately absorb sulforaphane
  • Allergy to cruciferous vegetables
  • Any condition which, in the opinion of the study clinician, would make participation in the study harmful to the patient

Trial locations and contacts

1 site in 1 country.

United States1 site

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: The Effects of Sulforaphane in Patients With Biochemical Recurrence of Prostate Cancer

This phase II trial studies how well sulforaphane works in treating patients with recurrent prostate cancer. Sulforaphane may prevent or slow the growth of certain cancers.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the proportion of patients who achieve a 50% decline in prostate-specific antigen (PSA) levels within 20 weeks of sulforaphane treatment.

SECONDARY OBJECTIVES:

  1. To determine the percentage change in PSA from baseline to the final measured value at the end of study as well as the maximal PSA decline that occurs while on study for each subject.

II. To determine the proportion of patients whose PSA has not doubled after full 20 weeks of sulforaphane treatment.

III. To determine the safety profile of sulforaphane. IV. To determine the pharmacokinetics (PK) of sulforaphane and its metabolites in blood.

  1. To determine the effect of sulforaphane supplementation on target pharmacodynamic (PD) modulation in peripheral blood cells.

VI. To assess the effect of Glutathione-S-Transferase Mu 1 (GSTM1) genotype on sulforaphane PK, PD.

VII. To collect frozen serum for future analysis of correlative biomarkers.

OUTLINE:

Patients receive sulforaphane orally (PO) once daily for 20 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 14-30 days and every 6 months for 12 months.

Being tested
Sulforaphane, Laboratory biomarker analysis, Pharmacological study
Keywords
sulforaphane, broccoli sprout extract (BSE), prostate cancer, recurrent prostate cancer, phase II
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • SulforaphaneDrug

    Also called Broccoli Sprout Extract (BSE)

    Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.

  • Laboratory biomarker analysisOther

    Correlative studies

  • Pharmacological studyOther

    Also called Pharmacological studies

    Correlative studies

Study groups in NCT01228084
Study groupRoleWhat they receive
SulforaphaneExperimentalSulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
Receives: Drug: Sulforaphane; Other: Laboratory biomarker analysis; Other: Pharmacological study

What is being measured

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

  1. Proportion of Patients Who Achieve a 50% Decline in Prostate-Specific Antigen (PSA) Levels

    To determine the proportion of patients who achieve a decline in PSA levels while receiving sulforaphane treatment. as a measure of anti-tumor activity in men with recurrent prostate cancer.

    Measured: Less than or equal to 20 weeks of sulforaphane treatment.

Secondary outcomes (7)

  1. Percent Change in PSA From Baseline to Final Measured Value at End of Study

    To determine the percentage change in PSA from baseline to the final measured value at the end of study.

    Measured: Measure at baseline and after stopping study treatment (less than or equal to 20 weeks of treatment with sulforaphane.)

  2. Minimum Percent Change in PSA (i.e., the Smallest Increase for Those With Increased PSA and the Greatest Decline for Those With Decreased PSA)

    Measured: PSA measured every 28 days while on study treatment, an average of 5 months

  3. Proportion of Patients Whose PSA Levels Have Not Doubled

    Measured: While on treatment with sulforaphane (less than or equal to 20 weeks.)

  4. Incidence of Grade 3 or Higher Treatment Related Toxicity

    Toxicities will be graded based on the NIH Cancer Therapy Evaluation Program (CTEP) Common Toxicity Criteria of Adverse Events Version 4.0 (http://ctep.cancer.gov). All adverse events of any grade (for example, abnormal laboratory values, etc.) deemed clinically significant by the investigator will be recorded as a measure of the safety profile of sulforaphane

    Measured: Continually through study and 14-30 days after last drug dose.

  5. Half-life of Sulforaphane (SFN) in Blood

    Measured: Day 1 of study treatment

  6. Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Null Genotype

    Measured: Day 1 of study treatment

  7. Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Intact Genotype

    Measured: Day 1 of study treatment

Timeline

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

  1. First posted25 Oct 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionMay 2012
  4. Study completionMay 2013

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01228084
Sponsor's protocol ID
6613
Other IDs
SOL-10082-L, 6613
Status last verified
Apr 2017
First submitted
19 Oct 2010
Last updated
28 Apr 2017
Data monitoring committee
Yes

Publications

  • Singh KB, Hahm ER, Alumkal JJ, Singh SV. Restoration of Immune Surveillance in Prostate Cancer Prevention by Sulforaphane in Hi-Myc Mice. Mol Carcinog. 2026 Jun;65(6):677-686. doi: 10.1002/mc.70106. Epub 2026 Mar 9.

    PubMed 41802185

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sulforaphane, Laboratory biomarker analysis and Pharmacological study in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by OHSU Knight Cancer Institute at 1 site 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 18 inclusion and 9 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 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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 3 Mar 2014). 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?

Proportion of Patients Who Achieve a 50% Decline in Prostate-Specific Antigen (PSA) Levels (time frame: Less than or equal to 20 weeks of sulforaphane treatment.). 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 NCT01228084, 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 28 Apr 2017; AzTrials last refreshed its copy on 6 Nov 2026.

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