Active — Not RecruitingPhase 1

Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer

United States20 participantsStarted 2021-12-07

Plain-language summary

This study will be undertaken to evaluate the feasibility of replacing systemic Androgen Deprivation Therapy (ADT) with targeted local delivery of an anti-androgen agent alone in patients in whom ADT + radiation therapy is indicated for the treatment of localized prostate cancer.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. National Comprehensive Cancer Network (NCCN) intermediate risk prostate cancer, OR
✓. NCCN high risk prostate cancer due to Gleason Grade 4 or 5 AND refuses to receive systemic ADT, OR
✓. NCCN high risk prostate cancer due to Prostate Specific Antigen (PSA) \> 20 AND refuses to receive systemic ADT.

What they're measuring

Feasibility of replacing systemic androgen tx with targeted local delivery

Timeframe: 27 months

Trial details

NCT IDNCT04943536

SponsorAlessa Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-24

View on ClinicalTrials.gov More Prostate Adenocarcinoma trials