Radioligand Therapy for Recurrent Prostate Cancer
(ROADSTER Trial)

Recruiting in Palo Alto (17 mi)

Overseen byGlenn Bauman, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Glenn Bauman

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?Approximately 50-60% of men undergoing salvage brachytherapy post cancer recurrence to the prostate have the disease controlled at 5 years. This study aims to integrate a local treatment to the prostate (brachytherapy) with a treatment involving 177Lutetium (Lu)- Prostate-Specific Membrane Antigen (PSMA) therapy. Differently than brachytherapy, 177-Lutetium-PSMA is thought to have its effect not only to the cancer cells within the prostate, but also to cancer cells located elsewhere in the body. Thus, the idea here is that by adding 177Lutetium (Lu)- PSMA early in the course of treatment we may be able to inactivate potential metastatic cells outside the prostate, while the prostate cancer within this organ still treated by the combination of brachytherapy and 177-Lutetium-PSMA.

Eligibility Criteria

Men with prostate cancer recurrence after prior radiotherapy, confirmed by biopsy. They must have adequate liver and kidney function, no severe toxicity from previous treatments, and meet specific blood count criteria. The trial excludes those who've had certain types of prostate radiotherapy before or show signs of cancer spread beyond the prostate.

Inclusion Criteria

I don't have severe urinary or digestive side effects from past treatments.

My prostate cancer has come back, confirmed by a biopsy.

My blood counts are within the required range without recent transfusions.

+8 more

Exclusion Criteria

I have had targeted radiation therapy to my prostate before.

Documented extraprostatic or distant recurrence on PSMA PET

I am not suitable for or have declined a specific cancer treatment procedure.

+3 more

Participant Groups

The study is testing a combination treatment for recurrent prostate cancer: high dose radiation (brachytherapy) alongside a radioactive drug called 177Lu-PSMA that targets cancer cells in the prostate and potentially elsewhere in the body.

2Treatment groups

Experimental Treatment

Active Control

Group I: Lutetium ArmExperimental Treatment2 Interventions

Patients in Lutetium Arm will receive 1 cycle of 177Lu-PSMA radioligand therapy plus 1 fraction of HDR brachytherapy.

Group II: High Dose Radiation (HDR) armActive Control1 Intervention

Patients in the HDR arm will receive two fractions of HDR brachytherapy. HDR brachytherapy will be administered as per local practice and as previously described. All procedures will be conducted under general anesthesia in a dedicated brachytherapy suite using transrectal three dimensional ultrasound for image guidance. For all HDR fractions at least 10Gy will be delivered to the entire prostate with a boost to 13.5Gy to the involved prostate as determined by biopsy and PSMA PET/MRI results. In instances of multi-focal/diffuse involvement of the prostate, the entire prostate will receive 13.5Gy/fraction (respecting OAR constraints).