ACTIVE_NOT_RECRUITING

White Button Mushroom Sup for the Reduction of PSA in Pts With Biochemically Rec or Therapy Naive Fav Risk Prostate CA

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Conditions

Prostate AdenocarcinomaPSA FailurePSA ProgressionRecurrent Prostate CarcinomaStage I Prostate Cancer AJCC v8Stage IIA Prostate Cancer AJCC v8Stage IIB Prostate Cancer AJCC v8Stage IIC Prostate Cancer AJCC v8Stage IIIA Prostate Cancer AJCC v8Stage IIIC Prostate Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial studies how well white button mushroom supplement works in reducing prostate-specific antigen (PSA) levels in patients with prostate cancer that has come back (recurrent) or has favorable risk and has not undergone any therapy (therapy naive). PSA is a blood marker of prostate growth. White button mushroom supplement may affect PSA level, various parameters of immune system and levels of hormones that may have a role in prostate cancer growth.

Official Title

A Randomized Phase 2 Trial of White Button Mushroom Supplement in Patients With Biochemically Recurrent Prostate Cancer Following Local Therapy and in Therapy Na?ve Patients With Favorable Risk Prostate Cancer Undergoing Active Surveillance

Quick Facts

Study Start:2021-05-10
Study Completion:2025-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04519879

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented informed consent of the participant and/or legally authorized representative
  2. * For therapy naive favorable risk prostate cancer (cohort 2 only): agreement to undergo baseline and 48 week prostate biopsy
  3. * Willing to forego non-study supplements containing mushroom for the duration of the study
  4. * Eastern Cooperative Oncology Group (ECOG) =\< 2
  5. * Histologically or cytologically confirmed history of adenocarcinoma of the prostate
  6. * BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: PSA failure defined as:
  7. * PSA of \>= 0.2 ng/mL that has increased above nadir following prostatectomy, OR
  8. * PSA increase of 2.0 ng/mL above post-therapy nadir if other primary local therapy was used instead of prostatectomy
  9. * NOTE: PSA value must be increasing based on 2 consecutive measurements taken at least 2 weeks apart
  10. * BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Testosterone levels \> 50 ng/dL
  11. * BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Received any number of primary local therapies, defined as:
  12. * Radical prostatectomy
  13. * External beam radiation therapy
  14. * Radioactive seed implantation
  15. * Cryotherapy
  16. * High-intensity focused ultrasound (HIFU)
  17. * BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: May have received up to 24 months of neoadjuvant/adjuvant androgen deprivation therapy in conjunction with primary local therapy. Androgen deprivation therapy must have been completed \> 6 months from day (D)1 of the study
  18. * BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Neoadjuvant/adjuvant cytotoxic chemotherapy must have been completed \> 6 months from day (D)1 of the study
  19. * BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: No clinical or radiographic evidence of metastatic disease within 2 months prior to day 1 of protocol therapy. If metastatic disease is detected by positron emission tomography (PET) imaging only patients are eligible as long as no metastatic disease is noted on computed tomography (CT) scan (or magnetic resonance imaging \[MRI\]) and bone scan
  20. * THERAPY NAIVE FAVORABLE RISK PROSTATE CANCER COHORT (COHORT 2) ONLY: Adenocarcinoma of the prostate diagnosed =\< 12 months of protocol screening and has elected active surveillance as preferred management plan OR already on active surveillance
  21. * THERAPY NAIVE FAVORABLE RISK PROSTATE CANCER COHORT (COHORT 2) ONLY: Clinical stage T1c-T2a as defined below:
  22. * T1c: Tumor identified by needle biopsy found in one or both sides, but not palpable
  23. * T2a: Tumor involves one-half of one side or less
  24. * THERAPY NAIVE FAVORABLE RISK PROSTATE CANCER COHORT (COHORT 2) ONLY: Gleason score =\< 6 (grade group 1) or Gleason 3+4 (grade group 2)
  25. * THERAPY NAIVE FAVORABLE RISK PROSTATE CANCER COHORT (COHORT 2) ONLY: Adequate biopsy of at least 10 biopsy cores
  26. * THERAPY NAIVE FAVORABLE RISK PROSTATE CANCER COHORT (COHORT 2) ONLY: No prior therapy for prostate cancer defined as:
  27. * Local therapy including surgery , radiation or focal therapy (cryoablation, HIFU, light)
  28. * Systemic therapy (hormonal, immunotherapy, targeted, chemotherapy). Subjects who have used 5-alpha reductase inhibitor (e.g. finasteride or dutasteride) \> 6 months prior to D1 of protocol therapy will be allowed
  29. * Platelets \> 100,000 /mm\^3 (within 28 days prior to day 1 of protocol therapy)
  30. * Hemoglobin \> 8 g/dL (within 28 days prior to day 1 of protocol therapy)
  31. * Aspartate aminotransferase, alanine aminotransferase, \< 3 x upper limit of normal (ULN) (within 28 days prior to day 1 of protocol therapy)
  32. * Total bilirubin \< 2 x ULN (within 28 days prior to day 1 of protocol therapy)
  33. * Creatinine \< 2 x ULN (within 28 days prior to day 1 of protocol therapy)
  1. * Other concomitant investigational anti-cancer therapy/ vaccines/biologics, corticosteroids with \> 10 mg of prednisone equivalent dose
  2. * Therapy with mushroom supplements within last 3 months of randomization
  3. * BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Neoadjuvant/adjuvant androgen derivation therapy lasting \> 24 months or within 6 months prior to day 1 of protocol therapy
  4. * BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Neoadjuvant/adjuvant chemotherapy within 6 months prior to day 1 of protocol therapy
  5. * BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Prior therapy for recurrent prostate cancer (unless given as a component of attempted curative salvage treatment including salvage radiation therapy, and completed \> 6 months before day 1 of protocol therapy):
  6. * Chemotherapy
  7. * Androgen deprivation therapy
  8. * Immunotherapy
  9. * Targeted therapy
  10. * Known history of allergic reaction to mushrooms
  11. * Clinically significant uncontrolled illness
  12. * Active infection requiring treatment
  13. * Uncontrolled congestive heart failure, cardiac arrhythmia
  14. * History of other primary non-skin malignancy within previous 2 years unless treated with curative intent and in remission
  15. * Any other condition that would, in the Investigator?s judgment, contraindicate the patient?s participation in the clinical study due to safety concerns with clinical study procedures
  16. * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Contacts and Locations

Principal Investigator

Clayton S Lau
PRINCIPAL_INVESTIGATOR
City of Hope Medical Center

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States
City of Hope at Glendora
Glendora, California, 91741
United States
City of Hope at Irvine Lennar
Irvine, California, 92618
United States
City of Hope Rancho Cucamonga
Rancho Cucamonga, California, 91730
United States
John Wayne Cancer Institute
Santa Monica, California, 90404
United States
City of Hope South Pasadena
South Pasadena, California, 91030
United States
City of Hope West Covina
West Covina, California, 91790
United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

  • Clayton S Lau, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-10
Study Completion Date2025-10-01

Study Record Updates

Study Start Date2021-05-10
Study Completion Date2025-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Prostate Adenocarcinoma
  • PSA Failure
  • PSA Progression
  • Recurrent Prostate Carcinoma
  • Stage I Prostate Cancer AJCC v8
  • Stage IIA Prostate Cancer AJCC v8
  • Stage IIB Prostate Cancer AJCC v8
  • Stage IIC Prostate Cancer AJCC v8
  • Stage IIIA Prostate Cancer AJCC v8
  • Stage IIIC Prostate Cancer AJCC v8