The impact of 18F-DCFPyL-PET/CT on the management of patients with recurrent PCa.

[pjoshea13]

Interesting results from a new study below [1].

"66% (226/341) had a PET-directed change in management.

"The most common change was conversion from observation or systemic therapy to surgery or radiation for loco-regional (n=74) or oligometastatic disease (n=30) or alternatively the addition of nodal-directed therapy to salvage surgery or radiation (n=37).

"Conclusion: Preliminary data from this prospective multicenter trial suggests the high detection rate of additional disease by PSMA PET in men with suspected low volume metastatic disease results in frequent change in management."

Hopefully, there was a positive effect on survival.

-Patrick

[1] jnm.snmjournals.org/content...

Preliminary results of a prospective, multicenter trial assessing the impact of 18F-DCFPyL-PET/CT on the management of patients with recurrent prostate cancer.

Ur Metser1, Katherine Zukotynski2, Wei Liu3, Deanna Langer4, Pamela MacCrostie5, L.K. Joseph Chin6, Antonio Finelli7, Laurence H. Klotz7, Anil Kapoor8, Luke T. LaVallee9 and Glenn Bauman10

+ Author Affiliations

1Joint Department of Medical Imaging University of Toronto Toronto ON Canada

2McMaster University Ancaster ON Canada

3Oncology Western University London ON Canada

4Cancer Care Ontario Toronto ON Canada

5Cancer Imaging Program Cancer Care Ontario Toronto ON Canada

6Division of Urology, Department of Surgery Western University, London, Ontario, Canada London ON Canada

7Division of Urology, Department of Surgery University of Toronto Toronto ON Canada

8Division of Urology, Department of Surgery McMaster University Hamilton ON Canada

9Division of Urology, Department of Surgery University of Ottawa Ottawa ON Canada

10Department of Oncology, Western University London ON Canada

Abstract

Purpose: A prospective, multicenter registry trial was conducted to assess disease detection rate and PET-directed change in the clinical management of men with suspected limited recurrent prostate cancer after primary therapy who subsequently had 18F-DCFPyL PET/CT (=PSMA PET) (NCT03718260).

Methods: The first 410 men enrolled in the study (December 2018-October 2019) formed the basis for this preliminary analysis. Eligibility included biochemical failure after primary therapy, either no or limited (≤4 sites) disease on conventional imaging (CT and bone scintigraphy) and one of the following predefined clinical cohorts: 1. Node positive or detectable serum PSA after radical prostatectomy (RP) 2. Post RP; 3. Post RP and pelvic radiotherapy; 4. Post RP or primary radiotherapy and androgen deprivation therapy; 5. Post radiotherapy for oligometastases; 6. Post primary radiotherapy. Results: 261/410 men (64%) had PET-detected lesions. PET detection rates among men with negative conventional imaging was 174/310 (56%). Among men with lesions on conventional imaging, new lesions were seen on PET in 63/100 (63%). Detection rate of any lesion by PSA level at enrollment were 54/139 (39%) for PSA <0.5; 49/78 (63%) 0.5-1.0 and 157/191 (82%) for PSA >1.0. On PSMA PET 49/410 men (12%) had local only disease, 95/410 (23%) had regional nodal without distant disease, and 117/410 (29%) had distant disease (non-regional nodal, bony or visceral); overall 144/410 (35%) had recurrent disease localized to the pelvis. The results for each cohort are presented in Table 1. Post PSMA PET planned management was recorded in 341/410 men. 66% (226/341) had a PET-directed change in management. The most common change was conversion from observation or systemic therapy to surgery or radiation for loco-regional (n=74) or oligometastatic disease (n=30) or alternatively the addition of nodal-directed therapy to salvage surgery or radiation (n=37). Conclusion: Preliminary data from this prospective multicenter trial suggests the high detection rate of additional disease by PSMA PET in men with suspected low volume metastatic disease results in frequent change in management. Long term follow-up is needed to determine whether this impacts disease control.

[cesanon]

""Conclusion: Preliminary data from this prospective multicenter trial suggests the high detection rate of additional disease by PSMA PET in men with suspected low volume metastatic disease results in frequent change in management.""

Patrick

I don't think I understand, but thisseems like it might be important. Can you explain what they are saying and what its significance is to patient decision making regarding treatment decisions?

[Graham49 in reply to cesanon]

My interpretation is that if you get recurrent PCa after primary treatment you need to get a PSMA scan so that it can be properly managed.

[tango65 in reply to Graham49]

It is also important to plan the initial treatment., particularly in intermediate and high risk cancers.

pubmed.ncbi.nlm.nih.gov/315....

[cesanon in reply to Graham49]

"results in frequent change in management"

So it would seem that it frequently results in changes in treatment decisions.

I guess,

1. Either from system treatment to localized? Or

2. From localized to systemic treatment? Or???

3. ?????????????

What do you think?

[Hidden in reply to cesanon]

My husband was part of that trial. His PSA was super high after Prostatectomy and the PSMA let us know that he was truly oligometastatic. The cat scan and bone only showed 2 mets. He then had all 5 Mets zapped with SBRT and added Erleada as well as Lupron. 🙏 for a long remission until a cure is discovered.

[pjoshea13 in reply to cesanon]

Experimental: Cohort 1

Men who are node positive or who have persistently detectable PSA after initial radical prostatectomy will be restaged with [18F]-DCFPyL PET/ CT scan (PSMA PET)

Diagnostic Test: [18F]-DCFPyL PET/ CT scan (PSMA PET)

Participants will undergo re-staging with [18F]-DCFPyL PET/CT Scan (PSMA PET).

***

Experimental: Cohort 2

Men with biochemical failure after initial prostatectomy will be restaged with [18F]-DCFPyL PET/ CT scan (PSMA PET)

Diagnostic Test: [18F]-DCFPyL PET/ CT scan (PSMA PET)

Participants will undergo re-staging with [18F]-DCFPyL PET/CT Scan (PSMA PET).

***

Experimental: Cohort 3

Men with biochemical failure after initial radical prostatectomy and salvage radiotherapy will be restaged with [18F]-DCFPyL PET/ CT scan (PSMA PET)

Diagnostic Test: [18F]-DCFPyL PET/ CT scan (PSMA PET)

Participants will undergo re-staging with [18F]-DCFPyL PET/CT Scan (PSMA PET).

***

Experimental: Cohort 4

Men with biochemical failure after initial radical prostatectomy with or without adjuvant/ salvage radiotherapy who are currently on salvage hormone therapy will be restaged with [18F]-DCFPyL PET/ CT scan (PSMA PET)

Diagnostic Test: [18F]-DCFPyL PET/ CT scan (PSMA PET)

Participants will undergo re-staging with [18F]-DCFPyL PET/CT Scan (PSMA PET).

***

Experimental: Cohort 5

Men who have prior metastases directed treatment for oligometastatic disease with subsequent biochemical failure will be restaged with [18F]-DCFPyL PET/ CT scan (PSMA PET)

Diagnostic Test: [18F]-DCFPyL PET/ CT scan (PSMA PET)

Participants will undergo re-staging with [18F]-DCFPyL PET/CT Scan (PSMA PET).

***

Experimental: Cohort 6

Men with biochemical failure after primary radiation therapy (external beam, brachytherapy or combinations together with or without hormone therapy) will be restaged with [18F]-DCFPyL PET/ CT scan (PSMA PET)

Diagnostic Test: [18F]-DCFPyL PET/ CT scan (PSMA PET)

Participants will undergo re-staging with [18F]-DCFPyL PET/CT Scan (PSMA PET).

***

Experimental: Cohort 7

[18F]-DCFPyL as a problem-solving tool in patients with prostate cancer when confirmation of the site of disease and/or disease extent may impact clinical management. Patients in this cohort require approval from an independent adjudication by Cancer Care Ontario.

Diagnostic Test: [18F]-DCFPyL PET/ CT scan (PSMA PET)

Participants will undergo re-staging with [18F]-DCFPyL PET/CT Scan (PSMA PET).

***

clinicaltrials.gov/ct2/show...

Primary Outcome Measures :

Frequency of disease detection on PSMA PET [ Time Frame: 5 years ]

The number of men with detectable lesions on PSMA PET who have suspected recurrent or persistent disease post radical prostatectomy with or without adjuvant or salvage pelvic radiotherapy or hormone therapy as well as men treated with primary radiotherapy will be measured

Secondary Outcome Measures :

Proportion of men with lesions detectable on PSMA PET imaging but not conventional imaging (CT or bone scan) [ Time Frame: 5 years ]

Number of lesions detected on PSMA PET compared to conventional imaging

Proportion of men with oligometastatic recurrence (four or fewer sites including the prostate bed if positive) confirmed on PSMA PET/CT [ Time Frame: 5 years ]

Number of men with four or fewer sites of disease detected on PSMA PET

Proportion of men with extensive recurrence (more than four sites including the prostate bed if positive) confirmed on PSMA PET/CT [ Time Frame: 5 years ]

Number of men with more than four sites of disease detected on PSMA PET

To determine rates of concordance in lesion detection between conventional imaging (CT/bone scan) and PSMA PET/CT [ Time Frame: 5 years ]

Number of lesions detected on both conventional imaging and PSMA PET

Proportion of men who have a change in usual management after PSMA PET [ Time Frame: 5 years ]

Number of men who have their management plan changed because of PSMA PET results

Proportion of men with detectable disease on PSMA PET/CT as a function of PSA parameters (absolute value, PSA velocity, PSA doubling time) [ Time Frame: 5 years ]

The frequency of lesions detected on PSMA PET according to the level of PSA at imaging

Other Outcome Measures:

Proportion of men with oligometastatic recurrence (four or fewer sites including the prostate bed) on PMSA PET/CT who undergo lesion directed therapy [ Time Frame: 5 years ]

The number of men who undergo lesion directed therapy after PSMA PET

To determine freedom from new systemic therapy in men undergoing targeted ablative therapy within 6 months after PSMA PET/CT [ Time Frame: 5 years ]

The number of men who remain off systemic therapy after PSMA PET imaging

To compare planned management after PSMA PET with actual management at 6 months after PSMA PET/CT [ Time Frame: 6 months ]

The number of men whose actual management plan within 6 months is the same as the specified plan at the time of PSMA PET imaging

***

More papers to follow.

-Patrick

[tango65]

They have found similar results using Ga68 PSMA PET/CT.

As I have said many times, if I have to do everything again I would not do any treatment (primary and after BCR treatments) without having a PSMA PET/CT done . The era of CT and bone scan has to end. We are years behind Europe and Australia in these diagnostic modalities.

[Moespy]

Had this PSMA Scan on a trial at NIH. T the time I was on my 2nd recurrence since RP in 2011 at 0.5 PSA. The Scan lit up a Lymph Node in my Pelvic Region and the subsequent biopsy verified PCa. Instead of waiting for my PSA to increase to 2.0 this scan enabled me to move forward with Radiation to the entire pelvic region and to move forward with Lupron. I have been undetectable for 18 months since then. Big fan of this Scan for early detection after recurrence.

[V10fanatic]

My Axumin PET only showed recurrence in the prostate. I took part in UCLA's PSMA PET trial and it picked up 5 other mets. Because of these findings, I switched my treatment plan completely. Instead of simply irradiating the prostrate I am now on Lupron and Zytiga, had Provenge and SBRT to the mets. Xgeva and possibly Xofigo are coming next.

[Hidden]

What was your PSA count prior to the PSMA test?

[paige20180]

My husband has had two reoccurrences where the Choline 11 PET found 1 or 2 lesions and SBRT was performed.

Our issue is Blue Cross has hired a third party EviCore and they have made it impossible to treat my husbands Ogliometastic disease. The Last round of SBRT the EviCore radiologist told our doctors at Hopkins SBRT was not necessary. PSA doubled every 3 weeks and treatment was delayed fighting EviCore who felt only a Lupron shot was needed. BCBS will not pay for PET imaging or even a MRI if PSA is less than 2. We have to pay for all of our imaging out of pocket as well as SBRT. I have a friend now that can not get SBRT.

Thank you for posting this study so I can try to use it to get reimbursed for the treatments we have had to pay for out of pocket. I hope you all are having better luck than us.

[j-o-h-n]

Looks good to me....

Good Luck, Good Health and Good Humor.

j-o-h-n Sunday 07/19/2020 6:59 PM DST

[immunity1]

I am a devotee to PET PSMA scans (F18 and Ga68) early in the disease for patients with aggressive PC, having had 6 over the past 4 years, following a diagnosis in 2010 (see profile) in order to manage my cancer. However, I do struggle to understand how some researchers bluntly say how much more sensitive these scans are relative to other modalities (even if they are). That is, how many false positive PET PSMA scans are there, if you are not doing histology to get a handle on actual disease (as a denominator). Or am I missing something?

[pjoshea13 in reply to immunity1]

As the author of a recent Dutch study commented:

"Histologic verification of PSMA PET findings for BCR (e.g. through histological biopsy) is often difficult and therefore scarcely performed." [1]

-Patrick

[1] pubmed.ncbi.nlm.nih.gov/314...

[immunity1]

Yes. Thanks. R