Trial · Interventional

CompletedPhase 2Results postedRegistry data

Exisulind and Intermittent Androgen Suppression (ADT) in Biochemical Relapsed Prostate Cancer

NCTNCT00283803Other id44830Other idEX1006

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Overview

Status: Completed
Phase: Phase 2
Enrollment: 32 participants (actual)
Sponsor: University of Washington · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 12 Mar 2002
Primary completion: Oct 2011
Completion: Oct 2011
First posted: 30 Jan 2006 (estimated)
Last update posted: 7 Aug 2018
Conditions: Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200220042006200820102012

Ph 2
Exisulind and Intermittent Androgen Suppression (ADT) in Biochemical Relapsed Prostate Cancer
NCT00283803
12 Mar 2002 to Oct 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this research study is to determine if an investigational drug called Exisulind will extend the "off-treatment" period of patients receiving Intermittent Androgen Suppression (ADT). There is evidence suggesting that alternating between periods of treatment and no treatment with androgen suppressants may delay the time to develop androgen-insensitive progression and improve overall quality of life. During intermittent androgen suppression (IAS) treatments, men receive a luteinizing hormone-releasing hormone (LHRH) agonist and antiandrogen for a fixed period of time (approximately 9 months) and then enter an off-treatment period, whose length will vary, depending on the rate of rise in the patient's Prostate-Specific Antigen (PSA). Once the PSA reaches an established threshold (1 ng/mL in men who have had a prostatectomy or 4 ng/ml in men with an intact prostate), androgen suppression will be re-initiated for another 9 months. These cycles of on-treatment/off-treatment will be repeated until patient no longer responds to the androgen suppression and it is clear that their cancer is progressing. It has been observed that off-treatment periods tend to become shorter with each successive cycle of androgen suppression, presumably due to the emergence of androgen-independent clones. This study proposes to look at exisulind, a pro-apoptotic drug, which may extend the off-treatment period in patients receiving IAS.

Interventions

ExisulindDrug
luteinizing hormone-releasing hormone (LHRH) agonistDrug
AntiandrogenDrug

Arms1

Experimental
IAS and Exisulind
Patients will receive intermittent dosing of hormone therapy with commercially supplied luteinizing hormone-releasing hormone (LHRH) agonist and anti-androgen to be chosen by physician per standard of care. Exisulind will be started 3 months prior to the end of the second cycle of hormone therapy. Patients will continue treatment with Exisulind beyond the completion of the second cycle of hormone therapy until they meet criteria for discontinuation.

Primary outcomes3

Outcomes the sponsor listed as primary.

Duration of the First "Off-treatment" Cycle in Patients Who Have Completed One Cycle of Intermittent Androgen Suppression With the Addition of Exisulind.
Time frame · From date of first treatment until the date of first documented progression or study withdrawal, whichever came first, assessed up to 10 years.
Registry description
Patients were monitored for the amount of time (number of weeks) that passed between the completion of a cycle of Intermittent Androgen Suppression with Exisulind and the need to re-initiate treatment with Intermittent Androgen Suppression. It was hoped that adding Exisulind to standard Androgen Suppression would extend the amount time before disease progression.
Time to Hormone-refractory Diseases in Patients Treated With Intermittent Androgen Suppression and Exisulind
Time frame · From date of first treatment until the date of first documented progression or study withdrawal, whichever came first, assessed up to 10 years.
Registry description
Patients were monitored for continued hormonal sensitivity of their disease from the time of the first treatment with Intermittent Androgen Suppression and Exisulind and the time at which point they were considered hormone-refractory (castrate resistant). The development of hormone-refractory disease was one of the criteria for withdraw from study treatment. For this protocol, hormone-refractory was defined as 2 consecutive rising PSAs at least 2 weeks apart while on an LHRH agonist (with or without an anti-androgen).
Number of Participants With Dose Hold, Dose Reduction, or Treatment Withdrawal for Toxicity.
Time frame · From date of first treatment until study withdrawal, assessed up to 10 years.
Registry description
Patients were monitored for toxicity related treatment modifications from the start of Exisulind through the time that there were withdrawn from study.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· From date of first treatment until the date of first documented progression or study withdrawal, whichever came first, assessed up to 10 years.

Duration of the First "Off-treatment" Cycle in Patients Who Have Completed One Cycle of Intermittent Androgen Suppression With the Addition of Exisulind.

Group	Value (Weeks)
IAS and Exisulind	39

Primary outcomeMedian· From date of first treatment until the date of first documented progression or study withdrawal, whichever came first, assessed up to 10 years.

Time to Hormone-refractory Diseases in Patients Treated With Intermittent Androgen Suppression and Exisulind

Group	Value (Weeks)
IAS and Exisulind	286

Primary outcomeCount of participants· From date of first treatment until study withdrawal, assessed up to 10 years.

Number of Participants With Dose Hold, Dose Reduction, or Treatment Withdrawal for Toxicity.

Group	Value (Participants)
IAS and Exisulind	6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
ExisulindPatients will receive intermittent dosing of hormone therapy with commercially supplied LHRH agonist and antiandrogen to be chosen by physician per standard of care. Exisulind will be started 3 months prior to the end of the second cycle of hormone therapy. Patients will continue treatment with Exisulind beyond the completion of the second cycle of hormone therapy until they meet criteria for discontinuation. Exisulind: Exisulind 125 mg	0 / 32	1 / 32	21 / 32

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 21 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * A willingness and ability to sign an informed consent document; * 21 years or of legal age; * Histologically or cytologically documented prostate cancer. * ECOG Performance status score of 0 or 1. * Received at least one cycle of IAS with an LHRH agonist and anti-androgen * Willingness to remain off chronic NSAIDs (with the exception of ibuprofen or naproxen), including COX 2 inhibitors and salicylates (e.g., aspirin, mesalamine, azodisalicylate, salsalate, sulfasalazine) for duration of the study. Patients on low dose aspirin for cardiovascular prevention may be included in the study. * Have not taken sulindac (Clinoril™) on regular basis for any indication for one week prior to enrollment and willing to remain off of sulindac for the duration of the study. * Patients with prior radiation must be 2 weeks from their last radiation-treatment and have recovered from all associated toxicity. Exclusion Criteria: * Known hypersensitivity to sulindac (Clinoril™) * ECOG Performance status score \> 1; * Patients previously on SWOG 9346 or 9921 trials, or any other trials using IAS for which adding exisulind may be confounding. * Patients may not have any evidence of hormone-refractory prostate cancer, i.e. 2 consecutive rises in PSA on LHRH agonist and anti-androgen * Active peptic ulcer disease; * Use of an investigational medication or device within one month of initiating study therapy; * Elevations of serum creatinine to above the upper limit of normal; * Platelet count \< 100,000/L; hgb \< 9.0 g/dL; absolute neutrophil count \< 1500/mm3 * Known hepatic, biliary tract, renal or hematologic dysfunction which in the opinion of the Investigator or Sponsor are clinically significant or would obscure laboratory analyses or are associated with lab abnormalities; * Any condition or any medication that may interfere with the conduct of the study. * Bilirubin \> ULN. Patients with elevated indirect bilirubin due to Gilbert's Syndrome will be eligible. * AST or ALT \>2.5 X ULN

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