Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for OligoRecurrenT Prostate Cancer

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The primary goal of this study is to determine if adding PET-directed local therapy improves disease control compared to standard systemic therapy alone in Veterans with oligorecurrent prostate cancer on PET/CT. The investigators will conduct a multi-institutional phase II/III randomized trial comparing SST with or without PET-directed local therapy using radiation or surgery to all metastases and if a local recurrence is present.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Bicalutamide; Docetaxel; Flutamide; Goserelin; Leuprolide; Methylprednisolone; Nilutamide; Prednisone; Triptorelin Pamoate

Criteria

Inclusion Criteria:

• Age 18 years and ECOG performance status 2.

• Histologically or cytologically confirmed prostate adenocarcinoma.

• Prior curative-intent local therapy with either upfront definitive radiotherapy (any modality) or prostatectomy +/- post-operative radiotherapy for localized prostate cancer

• Any T-classification, Gleason's Grade Group, and pre-treatment PSA at the time of initial curative-intent

• treatment are acceptable.

• Nx, N0, or N1 N-classification at the time of curative-intent local therapy

• No metastatic disease at the time of curative-intent local therapy

• Rising PSA suspicious for biochemical recurrence after local therapy. In general, this will be defined as:

• PSA 0.2 ng/ml x 2 after prostatectomy +/- post-operative radiotherapy

• Elevation of PSA 2 ng/ml above the nadir after definitive radiotherapy

• Two consecutively rising PSAs with evidence of metastasis on the imaging studies described in 5.6

• The following lab studies must be performed within 90 days of enrollment (except in patients who have already started SST):

• PSA

• Total testosterone > 100 ng/dl

• The following imaging studies must be performed within 90 days of enrollment (except in patients who have started SST):

• CT or MRI abdomen/pelvis

• Technetium (Tc99m-MDP) or sodium fluoride (NaF) bone scan (sodium fluoride preferred)

• FDA-approved standard of care PET/CT (currently PSMA, Fluciclovine, choline,)

• The imaging studies in 6 reveal a total of 1-5 lesions suspicious for nodal recurrence or metastasis from prostate cancer as determined by the official report.

• Veterans with radiographic evidence of local recurrence: There must be recurrence on imaging in at least one other site in addition to a local recurrence in the prostate, seminal vesicles, or prostate bed. In other words, patients with a local recurrence in the prostate, prostate bed, or seminal vesicles only are not eligible. The Veteran must be a candidate for salvage local therapy.

• If a Veteran has started SST for this recurrence prior to enrollment, he is eligible if all of the following criteria are met:

• He has been on SST for 120 days.

• The imaging studies required for enrollment were performed within 90 days prior to the SST start date. These studies will be entered as the enrollment studies.

• Biochemically recurrent PSA and serum testosterone > 100 ng/dl within 90 days prior to SST start.

• There is no evidence of castration-resistant prostate cancer (see section 11.4 for definition of castration-resistant prostate cancer)

• No other prior malignancy is allowed except for the following: adequately treated non-melanomatous skin cancer, adequately treated Stage 0, I, or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.

Exclusion Criteria:

• Any current or prior evidence of castration-resistant prostate cancer (two consecutive rises in serum PSA, obtained at a minimum of 1-week interval, with the final PSA value 1 ng/ml, while having a total testosterone < 50 ng/dl).

• Presence of a symptomatic metastasis that requires palliative radiotherapy.

• Any known brain metastases, presence of leptomeningeal disease, malignant spinal cord compression, or malignant cauda equina syndrome are not eligible.

• Prior nodal, bone, or visceral metastasis after curative-intent therapy other than those identified on the enrollment imaging studies, whether treated or untreated.

• Prior local therapy with surgery or radiation to the nodal or distant metastases identified on the enrollment PET/CT.

• Prior radiation therapy to any sites requiring PET-directed local therapy or salvage local therapy that will lead to prohibitively high risk of toxicity from subsequent local therapy, as determined by the treating radiation oncologist or surgeon/urologist.

• Any other previous or current condition, which, in the judgement of the responsible clinician, is likely to interfere with any STARPORT treatments or assessments.

• Patients with psychiatric illness/social situations that would limit compliance with study requirements.