Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer (Biolen + RT)
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|ClinicalTrials.gov Identifier: NCT04943536|
Recruitment Status : Recruiting
First Posted : June 29, 2021
Last Update Posted : October 8, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Adenocarcinoma||Drug: bicalutamide Radiation: Stereotactic body radiation therapy||Phase 1|
This study is a prospective, single-center, single-arm feasibility study. Up to 20 participants will be recruited to assess the safety and patient tolerance of Biolen for the localized delivery of bicalutamide into the prostate when delivered with radiotherapy.
At baseline, patients will undergo multiparametric MRI of the prostate. Study participants will have placement of the drug eluting Biolen implants. At the 8 week timepoint, participants will undergo repeat multiparametric MRI.
Participants will receive standard of care radiation therapy on weeks 9-11 and will be followed through 2 years post radiation. A third and fourth multiparametric MRI will be performed at 6 and 24 months after completion of radiation. Clinical labs and correlative sample collection and patient quality of life questionnaires will be administered at follow-up visits. Following completion of follow-up or removal from protocol, patients may be offered enrollment on long-term follow up protocols.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer|
|Actual Study Start Date :||October 1, 2021|
|Estimated Primary Completion Date :||October 1, 2024|
|Estimated Study Completion Date :||December 31, 2024|
Experimental: Biolen+Radiation Therapy
Localized single delivery of the Biolen implant (polymer + bicalutamide) with radiation therapy
localized anti-androgen therapy
Radiation: Stereotactic body radiation therapy
localized radiation therapy
- Feasibility of replacing systemic androgen tx with targeted local delivery [ Time Frame: 27 months ]Ability to successfully implant the prostate with Biolen and a lack of implant toxicity that interferes with the capacity to complete intended radiation therapy.
- Adverse Events [ Time Frame: through 27 months ]toxicity of localized delivery of bicalutamide
- MRI changes [ Time Frame: baseline versus 8 weeks post biolen implantation and 6 months post RT ]prostate and tumor volume changes
- Biochemical progression free survival [ Time Frame: 24 months post RT ]rate of biochemical progression free survival
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- Patients with biopsy proven localized prostate cancer in whom prostate radiation and ADT is appropriate therapy (such as Intermediate Risk localized prostate cancer)
- Patients must have at least 1 MRI detected; biopsy proven prostate cancer.
Patients diagnosed as one of the following:
- 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.
- Age >18 years.
- NCCN high risk patients eligible for treatment with systemic ADT who do not refuse systemic ADT.
- Patients receiving prior radiotherapy or surgery for prostate cancer.
- Patients receiving prior or ongoing ADT.
- Study participant unwilling or unable to undergo MRI, including patients with contra-indications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc.
- Use of 5 alpha reductase inhibitors (e.g. Finasteride or Dutasteride) within 3 months of screening or total use within the last two years prior to screening of > 3 months.
- Prostate volume more than 80 cc at prior MRI imaging.
- International Prostate Symptom Score ≥ 20.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04943536
|Contact: Deborah Citrin, MDfirstname.lastname@example.org|
|Contact: Theresa Cooley-Zgela, RNemail@example.com|
|United States, Maryland|
|National Cancer Institute||Recruiting|
|Bethesda, Maryland, United States, 20894|
|Principal Investigator: Deborah Citrin, MD|
|Principal Investigator:||Deborah Citrin, MD||National Cancer Institute (NCI)|
|Responsible Party:||Alessa Therapeutics Inc.|
|Other Study ID Numbers:||
|First Posted:||June 29, 2021 Key Record Dates|
|Last Update Posted:||October 8, 2021|
|Last Verified:||October 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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