White Button Mushroom Sup for the Reduction of PSA in Pts With Biochemically Rec or Therapy Naive… (NCT04519879) | Clinical Trial Compass
Active — Not RecruitingPhase 2
White Button Mushroom Sup for the Reduction of PSA in Pts With Biochemically Rec or Therapy Naive Fav Risk Prostate CA
United States133 participantsStarted 2021-05-10
Plain-language summary
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.
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria:
* Documented informed consent of the participant and/or legally authorized representative
* For therapy naive favorable risk prostate cancer (cohort 2 only): agreement to undergo baseline and 48 week prostate biopsy
* Willing to forego non-study supplements containing mushroom for the duration of the study
* Eastern Cooperative Oncology Group (ECOG) =\< 2
* Histologically or cytologically confirmed history of adenocarcinoma of the prostate
* BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: PSA failure defined as:
* PSA of \>= 0.2 ng/mL that has increased above nadir following prostatectomy, OR
* PSA increase of 2.0 ng/mL above post-therapy nadir if other primary local therapy was used instead of prostatectomy
* NOTE: PSA value must be increasing based on 2 consecutive measurements taken at least 2 weeks apart
* BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Testosterone levels \> 50 ng/dL
* BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Received any number of primary local therapies, defined as:
* Radical prostatectomy
* External beam radiation therapy
* Radioactive seed implantation
* Cryotherapy
* High-intensity focused ultrasound (HIFU)
* 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…