Impact of 68Ga-PSMA-11 PET on the management of biochemically recurrent prostate cancer in a prospective single-arm clinical trial.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 292-292
Author(s):  
Wolfgang Fendler ◽  
Justin Ferdinandus ◽  
Jeremie Calais ◽  
Matthias Eiber ◽  
Robert R. Flavell ◽  
...  

292 Background: Prostate-specific membrane antigen ligand positron emission tomography (PSMA PET) induced management changes in up to every second patient in smaller clinical trials. We aim to determine the impact of 68Ga-PSMA-11 PET/CT on management of biochemically recurrent prostate cancer in a large prospective cohort. Methods: We report management changes following PSMA PET, a secondary endpoint of a prospective multicenter trial in men with prostate cancer biochemical recurrence (NCT02940262 and NCT03353740). Pre-PET, Post-PET and Post-Treatment Questionnaires were sent to referring physicians recording working clinical summaries, intended and implemented therapeutic and diagnostic management. Results: Intended management change occurred in 260/382 (68%) patients. Intended change was considered major in 176/382 (46%) patients. Management pathway aligned with PET findings, i.e. change towards local/focal therapy for locoregional disease (54/126 patients, 44%) and towards systemic therapy or combination approaches for metastatic disease (106/153 patients, 69%). Intended management was implemented in 160/206 (78%) patients. Perceived site of disease was unknown in 259/382 (68%) patients before and 111/382 (29%) patients after PSMA PET. A total of 150 intended diagnostic tests, mostly CT (n=43, 29%) and bone Scans/NaF-PET (n=52, 35%), were prevented by PSMA PET. A total of 73 tests, mostly biopsies (n=44, 60%) requested by the study protocol, were triggered. Conclusions: Disease localization by PSMA PET translated into management changes in more than half of patients with biochemical recurrence of prostate cancer. More than twice as many diagnostic tests were prevented than triggered following PET. Clinical trial information: NCT02940262 and NCT03353740.

2016 ◽  
Vol 34 (3_suppl) ◽  
pp. e298-e298 ◽  
Author(s):  
Bernadette Marie Greenwood ◽  
Stuart May ◽  
John Francis Feller

e298 Background: Prostate cancer is commonly managed with radical prostatectomy (RP) or radiation therapy (RT). 20-40% of men undergoing RP experience biochemical recurrence (BCR) before 10 years. 30-50% or those receiving RT experience BCR. Treatment options for these men are limited and include: salvage radiation, close surveillance, androgen deprivation therapy (ADT), or participation in a clinical trial. Our IRB-approved study evaluated the use of transrectally delivered, MR-guided laser focal therapy with real-time MR thermometry for the treatment of recurrent prostate cancer. Methods: 63 y.o. patient treated September, 2014 with MR-guided laser focal salvage therapy for locally recurrent prostate cancer, Gleason score 4+5 involving the transition zone far anteriorly at the base level measuring 1.4 x 1.1 x 1.3 cm. The patient was originally diagnosed with Gleason score 4+3 adenocarcinoma of the prostate by MR ultrasound fusion biopsy in 2012 and subsequently underwent treatment with proton beam radiation therapy. Results: MR-guided biopsy of the prostate August, 2014 confirmed the presence of locally recurrent PCa. Before MR-guided laser focal therapy, the biochemical recurrence was documented with an elevated serum PSA equal to 5.7. The 3- and 6-month post laser focal therapy serum PSA levels were 0.5. It reached a nadir of 0.3 at one year following the laser ablation. Patient had negative 6-month follow-up MR-guided biopsy of treatment region and remains on active surveillance Conclusions: Following proton beam radiation therapy, transrectal MR-guided laser focal therapy achieved oncologic control at 12 months post-treatment. Clinical trial information: 02243033.


2021 ◽  
Vol 11 (11) ◽  
pp. 393-403
Author(s):  
Raquel García ◽  
Virginia Morillo ◽  
Pablo Sopena ◽  
Miguel R. Soler ◽  
María Rodríguez ◽  
...  

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 276-276
Author(s):  
Marleen Suzanne Vallinga ◽  
Anthonius Breeuwsma ◽  
Maxim Rybalov ◽  
Jan Pruim ◽  
Igle J. De Jong

276 Background: Salvage cryoablation is an effective but toxic treatment for local recurrent prostate cancer after primary radiotherapy. To assess the location of recurrent prostate cancer, an 11C-choline PET/CT can be used. We studied the clinical impact of 11C-choline PET/CT on the choice for and the results of salvage cryoablation. Methods: A total of 141 patients with a biochemical recurrence (BCR according to ASTRO-Phoenix criteria) after radiotherapy, and thus candidates for salvage cryoablation, were included. Patients were re-staged with an 11C-choline PET/CT, complementary prostate biopsies, when indicated a pelvic lymph node dissection and/or additional imaging. Change in choice of therapy was defined as major (no salvage cryoablation because of metastases or lack of local recurrence on PET/CT), minor (local salvage treatment was performed, but different technique of after additional diagnostics) or none (salvage cryoablation was performed). The impact of selection of patients for cryoablation with PET/CT on outcome was measured by time from cryoablation to BCR (according to Astro-Phoenix), first distant metastasis and start of hormonal therapy. Results: In 71 of 141 patients (51%) a change in therapy was implemented because of the result of 11C-choline PET/CT. A major impact was observed in 48 (34%) patients. In 83 patients, a salvage cryoablation was performed (59%). 18% of this group showed no PSA response. Of the remaining patients with PSA response, 37% developed a BCR after mean 25.7 months. 47% of patients are still in remission after a mean follow-up of 43 months. In 16 of 83 patients (19%) metastases were proven after mean 55.4 months (SD 26.3). 15 patients started with hormonal therapy, mean 29.5 months (SD 20.1) after cryoablation. Conclusions: 11C-choline PET/CT showed a significant impact on selection for salvage cryoablation. The choice for local salvage therapy was abandoned in 34% of patients. Of the men who underwent a salvage cryoablation, 47% stayed free of biochemical recurrence during mean 43 months follow-up.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5057-5057
Author(s):  
Tom Hope ◽  
Rahul Raj Aggarwal ◽  
Kirsten L Greene ◽  
Bryant Chee ◽  
Dora Tao ◽  
...  

5057 Background: PET imaging of prostate specific membrane antigen (PSMA) has been shown to have a higher sensitivity and specificity compared to conventional imaging. The objective was to evaluate the impact of PSMA PET on the management of prostate cancer patients with biochemical recurrence following local therapy. Methods: In our initial Ga-68-PSMA-11 PET protocol (NCT02611882), 150 patients with biochemical recurrence were imaged. 63 patients were imaged using PET/CT (GE Discovery VCT) and 63 patients using PET/MRI (GE Signa 3.0T PET/MRI). 110 patients received Lasix injections. Referring clinicians filled out a pretreatment management form and a management form based on the imaging results. Changes in management were graded as major, minor, no change or unknown based upon the responses. Results: We received both pre and post imaging forms in 126 patients, for an 84% response rate. The average PSA in the population was 5.9 ± 5.4 ng/mL with an average doubling time of 9.7 ± 11.0 months, and 60 patients had a PSA of less than 2.0 at the time of imaging. The average time between prior treatment and imaging (RP and/or radiation) was 5.3 ± 5.4 years, with 46 patients imaged within two years of their most recent treatment. 43 patients had a prior prostatectomy, 41 prior radiation, and 33 patients had both. 103 patients (82%) had disease localized on PSMA imaging. Of the 126 patients, 67 (53%) of the imaging studies resulted in a major change in management. The most common major change was converting from active surveillance to radiation therapy (15 patients, 12%), changing from ADT to radiation therapy (16 patients, 13%), and converting from radiation therapy to either active surveillance (6 patients, 5%) or to ADT alone (3 patients, 2%). 10 patients (8%) had a minor change, 42 patients (33%) had no change, and 7 patients (6%) had an unknown change in management. Conclusions: The results of our surveys demonstrate a substantial impact of PSMA PET on the intended patient management. The majority of changes involved converting a targeted therapy to systemic treatment or systemic treatment to a targeted therapy. Prospective studies are warranted to determine whether directed treatment towards PSMA-avid lesions affects long-term disease outcomes. Clinical trial information: NCT02611882.


2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 214-214 ◽  
Author(s):  
Ravi Amrit Madan ◽  
Renee Nicole Donahue ◽  
Harpreet Singh ◽  
Fatima Karzai ◽  
Marc Robert Theoret ◽  
...  

214 Background: Enzalutamide (enz) is FDA approved for advanced prostate cancer, but studies are evaluating enz in earlier stages of disease. We have conducted a clinical trial (NCT01875250) of enz ± a therapeutic vaccine in biochemically recurrent prostate cancer. Methods: Eligible patients (pts) had a PSA between 2.0-20.0 ng/ml, no metastatic disease and normal testosterone (T). Treatment for all pts included enz 160 mg daily for 84 days (D), but no T lowering therapy was permitted. This analysis evaluated all pts for the impact of enz on PSA and T regardless of randomization. Pts treated with Enz alone were evaluated for immune responses.The impact of the vaccine will be evaluated after protocol-defined requisite follow-up. Results: Median age for all pts (n = 34) was 66 years (range: 52-87), with a median on-study baseline PSA of 4.55 ng/ml (2.02-19.43). Common adverse events included fatigue and breast tenderness, but no pts discontinued enz for toxicity. The median PSA decline was 99% (range: 52% to > 99%) with 11/34 pts having undetectable nadirs. Median time to first PSA rise after 84 D course of enz was 29 D (13-70) and median recovery to baseline PSA in 25 evaluable pts was 190 D (84-469). T increased above normal limits in 18/34 pts (median Tmax = 802 ng/dl). Immune analysis (n = 12) indicated enz alone increased naïve T-cells and NK cells, and decreased several subsets of myeloid derived suppressor cells with a highly suppressive phenotype. Conclusions: The preliminary findings from this study suggest that short-course enz is well tolerated, leads to prolonged PSA suppression and enhanced immune responses in patients with biochemically recurrent prostate cancer. These immune studies provide the rationale for the use of enz in combination with immunotherapeutics in this and other malignancies. Clinical trial information: NCT01875250.


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