Trial Outcomes & Findings for Diindolylmethane in Treating Patients With Stage I or Stage II Prostate Cancer Undergoing Radical Prostatectomy (NCT NCT00888654)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

41 participants

Primary outcome timeframe

Within the first 24 months after radical prostatectomy.

Results posted on

2018-03-19

Participant Flow

Participant milestones

Participant milestones
Measure	B-Dim, Radical Prosatectomy B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) Radical Prostatectomy B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) Radical Prosatectomy
Overall Study STARTED	41
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	B-Dim, Radical Prosatectomy B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) Radical Prostatectomy B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) Radical Prosatectomy
Overall Study Problems swallowing oral meds.	1
Overall Study Not enough oral meds before surgery	3
Overall Study Surgery aborted	2
Overall Study Withdrawal by Subject	1
Overall Study Inelig. due to contraindication of med	1
Overall Study Change in surg date	1
Overall Study Stopped meds due to headaches	1

Baseline Characteristics

Diindolylmethane in Treating Patients With Stage I or Stage II Prostate Cancer Undergoing Radical Prostatectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	B-Dim, Radical Prosatectomy n=41 Participants B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) Radical Prostatectomy B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) Radical Prosatectomy
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants

PRIMARY outcome

Timeframe: Within the first 24 months after radical prostatectomy.

Population: Patients that were eligible, evaluable, and compliant

Outcome measures

Outcome measures
Measure	B-Dim, Radical Prosatectomy n=28 Participants B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) Radical Prostatectomy B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) Radical Prosatectomy
Mean Level of Diindolylmethane in Prostate Tissue After Treatment	14.2 ng/g Interval 10.6 to 17.7

SECONDARY outcome

Timeframe: Pre and post radical prostatectomy

Population: All enrolled patients except for one patient who was deemed ineligible due to a disallowed concomitant medication and for one patient whose prostatectomy was cancelled because of adhesions found at the time of surgery.

Serum levels of PSA, testosterone, and diindolylmethane (DIM)

Outcome measures

Outcome measures
Measure	B-Dim, Radical Prosatectomy n=39 Participants B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) Radical Prostatectomy B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) Radical Prosatectomy
Serum Levels of PSA, Testosterone, and Diindolylmethane Pre-treatment PSA	6.4 ng/ml Interval 2.1 to 29.4
Serum Levels of PSA, Testosterone, and Diindolylmethane Post-treatment PSA	5.8 ng/ml Interval 2.6 to 28.3
Serum Levels of PSA, Testosterone, and Diindolylmethane Pre-treatment Testosterone	301 ng/ml Interval 77.0 to 608.0
Serum Levels of PSA, Testosterone, and Diindolylmethane Post-treatment Testosterone	388 ng/ml Interval 110.0 to 686.0
Serum Levels of PSA, Testosterone, and Diindolylmethane Pre-treatment DIM	0.0 ng/ml Interval 0.0 to 0.0
Serum Levels of PSA, Testosterone, and Diindolylmethane Post-treatment DIM	7.5 ng/ml Interval 0.0 to 24.7

SECONDARY outcome

Timeframe: Pre and post radical prostatectomy

Population: All enrolled patients except for one patient who was deemed ineligible due to a disallowed concomitant medication and for one patient whose prostatectomy was cancelled because of adhesions found at the time of surgery.

Levels of androgen receptor in prostate tissue as measured by AR score (intensity x % cells stained), higher scores indicate higher levels of androgen receptor in prostate tissue.

Outcome measures

Outcome measures
Measure	B-Dim, Radical Prosatectomy n=39 Participants B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) Radical Prostatectomy B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) Radical Prosatectomy
Levels of Androgen Receptor in Prostate Tissue Pre-BR-DIM Androgen Receptor	278 AR score (intensity x % cells stained) Interval 263.0 to 293.0
Levels of Androgen Receptor in Prostate Tissue Post-BR-DIM Androgen Receptor	245 AR score (intensity x % cells stained) Interval 227.0 to 263.0

Adverse Events

B-Dim, Radical Prosatectomy

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	B-Dim, Radical Prosatectomy n=41 participants at risk B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) Radical Prostatectomy B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) Radical Prosatectomy
Nervous system disorders Headache	4.9% 2/41 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Elisabeth Heath, M.D.

Barbara Ann Karmanos Cancer Institute

Phone: 313-576-8715

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place