CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 464 target
Drug / intervention
Goserelin, Histrelin, Leuprolide & Triptorelin +11 moredrug
Likely dose
Not stated in record
Key inclusion· 19
  • ✓Age 18 years or older
  • ✓ECOG Performance Status 2 at enrollment
  • ✓Prostate cancer confirmed histologically or cytologically
  • ✓Prior curative-intent local therapy to all sites (radiotherapy or prostatectomy ± post-operative radiotherapy) if recurrent
Key exclusion· 7
  • ✕Current or prior castration-resistant prostate cancer (consecutive PSA rises with PSA ≥1 ng/ml at testosterone <50 ng/dl)
  • ✕Prior malignancy except: non-melanomatous skin cancer, Stage 0-II cancer in complete remission, or any cancer disease-free for 3 years
  • ✕Symptomatic metastasis requiring palliative radiotherapy
  • ✕Brain metastases, leptomeningeal disease, malignant spinal cord compression, or malignant cauda equina syndrome

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04787744
NCT04787744Phase 3RecruitingOn TrackUpdated 2mo ago
Long Recruiting
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Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for OligoRecurrenT Prostate Cancer (VA STARPORT)

VA Office of Research and Development·interventional·Posted Mar 9, 2021·Updated Apr 8, 2026

In Brief

A Phase 3 clinical trial evaluating PET-directed Local Therapy using Surgery, PET-directed Local Therapy using Radiation, and 10 other interventions for Prostate Cancer and 5 related conditions. Currently recruiting, targeting 464 participants across 20 sites.

Detailed Summary

This is a prospective, open-label, multi-center seamless phase II to phase III randomized clinical trial designed to compare SST with or without PET-directed local therapy in improving the castration-resistant prostate cancer-free survival (CRPC-free survival) for Veterans with oligometastatic prostate cancer. Oligometastasis will be defined as 1-10 sites of metastatic disease based on the clinical determination of the LSI which incorporates all imaging, clinical, and pathologic data available.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer, Oligometastasis, Oligorecurrence, Recurrent Prostate Cancer, Metastatic Prostate Cancer, De Novo Prostate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 3Recruiting
202120222023202420252026202720282029
First PostedMar 9, 2021
Enrollment StartJul 1, 2021
Primary CompletionSep 30, 2026
Study CompletionMar 30, 2029
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 5.3 years agoPrimary completion in 3 months

Interventions

PET-directed Local Therapy using Surgeryprocedure

Surgery will be used to treat metastases.

PET-directed Local Therapy using Radiationradiation

Radiation therapy will be used to treat metastases. Radiation options include: 1. Stereotactic body radiotherapy (SBRT) using 1-10 fractions 2. Conventionally fractionated radiotherapy using elective nodal radiotherapy and a simultaneous integrated boost to involved nodes The selection of the form of metastasis-directed radiotherapy for each metastasis will be determined using shared decision-making between the treating physician and the Veteran.

Salvage Local Therapy for locally recurrent diseaseother

For Veterans who have a local recurrence in addition to oligorecurrent metastatic lesions, they will undergo salvage local therapy using brachytherapy, SBRT, surgery, cryotherapy or HIFU. The selection of modality of salvage local therapy will be determined using shared decision-making between the treating physician and Veteran.

Goserelin, Histrelin, Leuprolide & Triptorelindrug

Androgen deprivation therapy (ADT) using an LHRH agonist

ADT + Nilutamide, Flutamide, & Bicalutamidedrug

ADT adding anti-androgen therapy to an LHRH agonist

Degarelix & Relugolixdrug

ADT using an LHRH Antagonist.

ADT + Docetaxel +/- prednisonedrug

Enhanced SST using chemohormonal therapy

ADT + Abiraterone + Prednisonedrug

Enhanced SST using Abiraterone + Prednisone

ADT + Abiraterone + Methylprednisolonedrug

Enhanced SST using Abiraterone + Methylprednisolone

ADT + Apalutamidedrug

Enhanced SST using ADT + Apalutamide

ADT + Enzalutamidedrug

Enhanced SST using ADT + Enzalutamide

Prostate-directed Radiation for De novo oligometastatic prostate cancerradiation

Veterans in ARM 1 will receive prostate-directed RT only and NO treatment to any nodal or distant metastatic sites. Acceptable dose/fractionations include 55 Gy in 20 fractions and 36 Gy in 6 fractions. Veterans in ARM 2 should receive prostate-directed local therapy using radiotherapy or radical prostatectomy in addition to PET-directed local therapy to metastases.