Sulforaphane in Treating Patients With Recurrent Prostate Cancer

NCT01228084 | Completed Phase 2 Results DMC

• 2 other identifiers: 6613SOL-10082-L
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adenocarcinoma of the Prostate; Recurrent Prostate Cancer

Keywords

sulforaphane; broccoli sprout extract (BSE); prostate cancer; recurrent prostate cancer; phase II

Outcome Measures

Primary Outcomes (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.

  Less than or equal to 20 weeks of sulforaphane treatment.

Secondary Outcomes (7)

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

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

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

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

• Proportion of Patients Whose PSA Levels Have Not Doubled

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

• Incidence of Grade 3 or Higher Treatment Related Toxicity

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

• Half-life of Sulforaphane (SFN) in Blood

  Day 1 of study treatment

Study Arms (1)

Sulforaphane

EXPERIMENTAL

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.

Drug: Sulforaphane; Other: Laboratory biomarker analysis; Other: Pharmacological study

Interventions

Sulforaphane DRUG

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.

Also known as: Broccoli Sprout Extract (BSE)

Sulforaphane

Laboratory biomarker analysis OTHER

Correlative studies

Sulforaphane

Pharmacological study OTHER

Correlative studies

Also known as: Pharmacological studies

Sulforaphane

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• The Wayne D. Kuni and Joan E. Kuni Foundation: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Joshi Alumkal, MD
• Organization: Oregon Health & Science University, Knight Cancer Institute

503-494-1091

Study Officials

• Joshi J Alumkal, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 25, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2013
• Last Updated: April 28, 2017
• Results First Posted: March 3, 2014

Record last verified: 2017-04

Locations

US (1)