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

Conditions

• De Novo Prostate Cancer
• Metastatic Prostate Cancer
• Oligometastasis
• Oligorecurrence
• Prostate Cancer
• Recurrent Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PET-directed Local Therapy using Surgery — PROCEDURE
  Surgery will be used to treat metastases.
• PET-directed Local Therapy using Radiation — RADIATION
  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 disease — OTHER
  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 & Triptorelin — DRUG
  Androgen deprivation therapy (ADT) using an LHRH agonist
• ADT + Nilutamide, Flutamide, & Bicalutamide — DRUG
  ADT adding anti-androgen therapy to an LHRH agonist
• Degarelix & Relugolix — DRUG
  ADT using an LHRH Antagonist.
• ADT + Docetaxel +/- prednisone — DRUG
  Enhanced SST using chemohormonal therapy
• ADT + Abiraterone + Prednisone — DRUG
  Enhanced SST using Abiraterone + Prednisone
• ADT + Abiraterone + Methylprednisolone — DRUG
  Enhanced SST using Abiraterone + Methylprednisolone
• ADT + Apalutamide — DRUG
  Enhanced SST using ADT + Apalutamide
• ADT + Enzalutamide — DRUG
  Enhanced SST using ADT + Enzalutamide
• Prostate-directed Radiation for De novo oligometastatic prostate cancer — RADIATION
  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.

Study Details

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.

Key Dates

Start date

Jul 1, 2021

Status verified

Apr 2026

Primary completion

Sep 30, 2026

Completion

Mar 30, 2029

Study Design

Enrollment

464 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Standard Systemic Therapy (SST)
  All Veterans will receive SST (if De novo, Veterans will receive prostate-directed radiation).
• Experimental: SST + PET-directed local therapy
  In addition to SST, all Veterans will receive PET-directed local therapy to all metastases using surgery or radiation. If De novo, Veterans will also receive prostate-directed radiation or radical prostatectomy to treat the prostate/prostate bed. The best course of treatment will be determined using shared decision-making between the physician and Veteran.

Primary Outcome Measure

Castration-resistant prostate cancer-free survival (CRPC-free survival) [ Time Frame: 4 years ]

Central Contacts

• Abhishek Solanki, MD MS
  (708) 202-8387
  [email protected]

Locations (20)

Find similar trials in Long Beach, CA

Related Studies

• Collection of Blood From Patients With Cancer
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
  Enrolling By Invitation · National Institutes of Health Clinical Center (CC) · Bethesda, Maryland
• Follow-Up Study of Subjects Previously Enrolled in Poxviral Vector Gene Transfer Studies
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer
  Recruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey